CSMS# 16-000428 - FDA New and End-Dated Product Codes and New Product Classes for CDER and CVM Products
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05/26/2016 03:43 PM EDT
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The Food And Drug Administration has end-dated CDER product codes due to duplication effective 4/25/16, created new CDER product codes effective immediately, and created new CVM Class Codes and new CVM product codes, effective immediately. The changes are described below.
The Food And Drug Administration will be deleting the following CDER product codes below due to duplication. These product codes will be deleted effective 4/25/2016, and the use of these codes after that date will result in a data transmission error. The correct codes to use are also listed below, which are available for use immediately.
The following product codes were deleted effective 4/25/16:
End-dated Code/Description
62G[][]58-Infliximab
Correct Code/Description
61Y[][]01-Infliximab
End-dated Code/Description
62Z[][]07-Filgrastim
Correct Code/Description
64Y[][]02-Filgrastim
The Food And Drug Administration has added the following new Class Code and Product Codes for CDER products, which will become effective immediately, for use under Industry Code 60 - Human and Animal Drugs:
New Class Code/Description
Y- Inhibitor (Growth Factor)
New Product Code/Description
60Y[][]01- Aflibercept (Inhibitor (Growth Factor))
60Y[][]99- Inhibitor (Growth Factor) N.E.C.
The Food And Drug Administration has added the following new Class Code and Product Codes for CDER products, which will become effective immediately, for use under Industry Code 66 - Human and Animal Drugs:
New Class Code/Description
W- Immunomodulator
New Product Code/Description
66W[][]01- Abatacept (Immunomodulator)
66W[][]02- Rilonacept (Immunomodulator)
66W[][]99- Immunomodulator N.E.C.
The following CDER product codes are available immediately:
New Product/Description
62Z[][]17- Ziv-Aflibercept (Anti-Neoplastic - Part II)
62Z[][]18-Ado-Trastuzumab Emtansine (Anti-Neoplastic - Part II)
62Z[][]19-Aldesleukin (Anti-Neoplastic - Part II)
62Z[][]20-Blinatumomab (Anti-Neoplastic - Part II)
62Z[][]21-Brentuximab Vedotin (Anti-Neoplastic - Part II)
62Z[][]22-Denileukin Diftitox (Anti-Neoplastic - Part II)
62Z[][]23-Dinutuximab (Anti-Neoplastic - Part II)
62Z[][]24-Ibritumomab Tiuxetan (Anti-Neoplastic - Part II)
62Z[][]25-Ipilimumab (Anti-Neoplastic - Part II)
62Z[][]26-Nivolumab (Anti-Neoplastic - Part II)
62Z[][]27-Obinutuzumab (Anti-Neoplastic - Part II)
62Z[][]28-Ofatumumab (Anti-Neoplastic - Part II)
62Z[][]29-Panitumumab (Anti-Neoplastic - Part II)
62Z[][]30-Pegaspargase (Anti-Neoplastic - Part II)
62Z[][]31-Pembrolizumab (Anti-Neoplastic - Part II)
62Z[][]32-Pertuzumab (Anti-Neoplastic - Part II)
62Z[][]33-Ramucirumab (Anti-Neoplastic - Part II)
62Z[][]34-Rituximab (Anti-Neoplastic - Part II)
62Z[][]35-Trastuzumab (Anti-Neoplastic - Part II)
64E[][]05-Collagenase (Enzyme)
64E[][]06-Collagenase Clostridium Histolyticum (Enzyme)
64T[][]10- Alefacept (Immunosuppressive)
64T[][]11- Belatacept (Immunosuppressive)
The Food And Drug Administration has added the following new Class Code and Product Code for CVM products, which will become effective immediately, for use under Industry Code 70 - Animal Food(Non-Medicated Feed and Feed Ingreds):
New Class Code/Description
E – Binding Agents
New Product Code/Description
70 E[][] 01 – Lignin Sulfonates
Additionally the Food And Drug Administration has added the following new Class Codes and Product Codes for CVM products, which will become effective immediately, for use under Industry Code 72-Pet/Laboratory Animal Food.
New Class Code/Description
F-Pet Chews (Non-Nutritive)
G-Pet Treats
New Product Code/Description
72F[][]01-Rawhide, Beef, Pet Chews (Non-Nutritive)
72F[][]02-Rawhide, Horse, Pet Chews (Non-Nutritive)
72F[][]03-Rawhide, Pork, Pet Chews (Non-Nutritive)
72F[][]04-Rawhide, Sheep, Pet Chews (Non-Nutritive)
72F[][]05-Rawhide, Sheep, Pet Chews (Non-Nutritive)
72F[][]06-Ears, Pork, Pet Chews (Non-Nutritive)
72F[][]07-Ears, Beef, Pet Chews (Non-Nutritive)
72F[][]08-Ears, Sheep, Pet Chews (Non-Nutritive)
72F[][]09-Ears, Combination Products, Pet Chews (Non-Nutritive)
72F[][]10-Feet, Poultry, Pet Chews (Non-Nutritive)
72F[][]11-Feet, Pork, Pet Chews (Non-Nutritive)
72F[][]12-Feet, Beef, Pet Chews (Non-Nutritive)
72F[][]13-Feet, Sheep, Pet Chews (Non-Nutritive)
72F[][]14-Bone, Beef, Pet Chews (Non-Nutritive)
72F[][]15-Bone, Sheep, Pet Chews (Non-Nutritive)
72F[][]16-Bone, Pork, Pet Chews (Non-Nutritive)
72F[][]17-Bone, Poultry, Pet Chews (Non-Nutritive)
72F[][]18-Noses, Pork, Pet Chews (Non-Nutritive)
72F[][]19-Tongues, Beef, Pet Chews (Non-Nutritive)
72F[][]20-Pizzles, Beef, Pet Chews (Non-Nutritive)
72F[][]21-Pizzles, Pork, Pet Chews (Non-Nutritive)
72F[][]22-Pizzles, Sheep, Pet Chews (Non-Nutritive)
72F[][]23-Ligaments, Beef, Pet Chews (Non-Nutritive)
72F[][]24-Ligaments, Pork, Pet Chews (Non-Nutritive)
72F[][]25-Ligaments, Sheep, Pet Chews (Non-Nutritive)
72F[][]26-Antlers, Deer, Wild Game Chews, Pet Chews (Non-Nutritive)
72F[][]27-Antlers, Elk, Wild Game Chews, Pet Chews (Non-Nutritive)
72F[][]28-Antlers, Moose, Wild Game Chews, Pet Chews (Non-Nutritive)
72F[][]99-Pet Chews (Non-Nutritive), N.E.C.
72G[][]01-Meat (Mammalian muscle), Pet Treats
72G[][]02-Poultry Products, Pet Treats
72G[][]03-Fish-Seafood Products. Pet Treats
72G[][]04-Cereal/Veg/Grain Products (corn, oats, barley, etc.), Pet Treats
72G[][]05-Combination Products, Pet Treats
72G[][]06-Oil-based Products, Pet Treats
72G[][]07-Pet Treats with Dairy Products, Pet Treats
72G[][]99-Pet Treats, N.E.C.
Please send any questions or concerns to the email address for the Product Code Builder Feedback PCBFeedback@fda.hhs.gov.
The Food And Drug Administration has end-dated CDER product codes due to duplication effective 4/25/16, created new CDER product codes effective immediately, and created new CVM Class Codes and new CVM product codes, effective immediately. The changes are described below.
The Food And Drug Administration will be deleting the following CDER product codes below due to duplication. These product codes will be deleted effective 4/25/2016, and the use of these codes after that date will result in a data transmission error. The correct codes to use are also listed below, which are available for use immediately.
The following product codes were deleted effective 4/25/16:
End-dated Code/Description
62G[][]58-Infliximab
Correct Code/Description
61Y[][]01-Infliximab
End-dated Code/Description
62Z[][]07-Filgrastim
Correct Code/Description
64Y[][]02-Filgrastim
The Food And Drug Administration has added the following new Class Code and Product Codes for CDER products, which will become effective immediately, for use under Industry Code 60 - Human and Animal Drugs:
New Class Code/Description
Y- Inhibitor (Growth Factor)
New Product Code/Description
60Y[][]01- Aflibercept (Inhibitor (Growth Factor))
60Y[][]99- Inhibitor (Growth Factor) N.E.C.
The Food And Drug Administration has added the following new Class Code and Product Codes for CDER products, which will become effective immediately, for use under Industry Code 66 - Human and Animal Drugs:
New Class Code/Description
W- Immunomodulator
New Product Code/Description
66W[][]01- Abatacept (Immunomodulator)
66W[][]02- Rilonacept (Immunomodulator)
66W[][]99- Immunomodulator N.E.C.
The following CDER product codes are available immediately:
New Product/Description
62Z[][]17- Ziv-Aflibercept (Anti-Neoplastic - Part II)
62Z[][]18-Ado-Trastuzumab Emtansine (Anti-Neoplastic - Part II)
62Z[][]19-Aldesleukin (Anti-Neoplastic - Part II)
62Z[][]20-Blinatumomab (Anti-Neoplastic - Part II)
62Z[][]21-Brentuximab Vedotin (Anti-Neoplastic - Part II)
62Z[][]22-Denileukin Diftitox (Anti-Neoplastic - Part II)
62Z[][]23-Dinutuximab (Anti-Neoplastic - Part II)
62Z[][]24-Ibritumomab Tiuxetan (Anti-Neoplastic - Part II)
62Z[][]25-Ipilimumab (Anti-Neoplastic - Part II)
62Z[][]26-Nivolumab (Anti-Neoplastic - Part II)
62Z[][]27-Obinutuzumab (Anti-Neoplastic - Part II)
62Z[][]28-Ofatumumab (Anti-Neoplastic - Part II)
62Z[][]29-Panitumumab (Anti-Neoplastic - Part II)
62Z[][]30-Pegaspargase (Anti-Neoplastic - Part II)
62Z[][]31-Pembrolizumab (Anti-Neoplastic - Part II)
62Z[][]32-Pertuzumab (Anti-Neoplastic - Part II)
62Z[][]33-Ramucirumab (Anti-Neoplastic - Part II)
62Z[][]34-Rituximab (Anti-Neoplastic - Part II)
62Z[][]35-Trastuzumab (Anti-Neoplastic - Part II)
64E[][]05-Collagenase (Enzyme)
64E[][]06-Collagenase Clostridium Histolyticum (Enzyme)
64T[][]10- Alefacept (Immunosuppressive)
64T[][]11- Belatacept (Immunosuppressive)
The Food And Drug Administration has added the following new Class Code and Product Code for CVM products, which will become effective immediately, for use under Industry Code 70 - Animal Food(Non-Medicated Feed and Feed Ingreds):
New Class Code/Description
E – Binding Agents
New Product Code/Description
70 E[][] 01 – Lignin Sulfonates
Additionally the Food And Drug Administration has added the following new Class Codes and Product Codes for CVM products, which will become effective immediately, for use under Industry Code 72-Pet/Laboratory Animal Food.
New Class Code/Description
F-Pet Chews (Non-Nutritive)
G-Pet Treats
New Product Code/Description
72F[][]01-Rawhide, Beef, Pet Chews (Non-Nutritive)
72F[][]02-Rawhide, Horse, Pet Chews (Non-Nutritive)
72F[][]03-Rawhide, Pork, Pet Chews (Non-Nutritive)
72F[][]04-Rawhide, Sheep, Pet Chews (Non-Nutritive)
72F[][]05-Rawhide, Sheep, Pet Chews (Non-Nutritive)
72F[][]06-Ears, Pork, Pet Chews (Non-Nutritive)
72F[][]07-Ears, Beef, Pet Chews (Non-Nutritive)
72F[][]08-Ears, Sheep, Pet Chews (Non-Nutritive)
72F[][]09-Ears, Combination Products, Pet Chews (Non-Nutritive)
72F[][]10-Feet, Poultry, Pet Chews (Non-Nutritive)
72F[][]11-Feet, Pork, Pet Chews (Non-Nutritive)
72F[][]12-Feet, Beef, Pet Chews (Non-Nutritive)
72F[][]13-Feet, Sheep, Pet Chews (Non-Nutritive)
72F[][]14-Bone, Beef, Pet Chews (Non-Nutritive)
72F[][]15-Bone, Sheep, Pet Chews (Non-Nutritive)
72F[][]16-Bone, Pork, Pet Chews (Non-Nutritive)
72F[][]17-Bone, Poultry, Pet Chews (Non-Nutritive)
72F[][]18-Noses, Pork, Pet Chews (Non-Nutritive)
72F[][]19-Tongues, Beef, Pet Chews (Non-Nutritive)
72F[][]20-Pizzles, Beef, Pet Chews (Non-Nutritive)
72F[][]21-Pizzles, Pork, Pet Chews (Non-Nutritive)
72F[][]22-Pizzles, Sheep, Pet Chews (Non-Nutritive)
72F[][]23-Ligaments, Beef, Pet Chews (Non-Nutritive)
72F[][]24-Ligaments, Pork, Pet Chews (Non-Nutritive)
72F[][]25-Ligaments, Sheep, Pet Chews (Non-Nutritive)
72F[][]26-Antlers, Deer, Wild Game Chews, Pet Chews (Non-Nutritive)
72F[][]27-Antlers, Elk, Wild Game Chews, Pet Chews (Non-Nutritive)
72F[][]28-Antlers, Moose, Wild Game Chews, Pet Chews (Non-Nutritive)
72F[][]99-Pet Chews (Non-Nutritive), N.E.C.
72G[][]01-Meat (Mammalian muscle), Pet Treats
72G[][]02-Poultry Products, Pet Treats
72G[][]03-Fish-Seafood Products. Pet Treats
72G[][]04-Cereal/Veg/Grain Products (corn, oats, barley, etc.), Pet Treats
72G[][]05-Combination Products, Pet Treats
72G[][]06-Oil-based Products, Pet Treats
72G[][]07-Pet Treats with Dairy Products, Pet Treats
72G[][]99-Pet Treats, N.E.C.
Please send any questions or concerns to the email address for the Product Code Builder Feedback PCBFeedback@fda.hhs.gov.
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