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CSMS #41120271 - Food and Drug Administration (FDA) End-Dated and New Center for Drug Evaluation and Research (CDER) Product Codes

The Food and Drug Administration (FDA) will be end-dating a Center for Drug Evaluation and Research (CDER) product code listed below in 30 days. The end-date will be effective on January 27, 2020.

End-dated Code/Description

64R—10/ Seractide Acetate (Hormone)

The Food and Drug Administration (FDA) has added new Center for Drug Evaluation and Research (CDER) product codes listed below and are available immediately.

New Product Code/Description:

56D—81/Plazomicin Sulfate (Aminoglycosides)

56I—77/Rifamycin Sodium (Macrolides)

60C—59/Lofexidine Hydrochloride (Adrenergic)

60N—22/Testosterone Undecanoate (Androgen)

60O—03/Bremelanotide Acetate (Agonist)

60O—04/Linaclotide (Agonist)

61K—74/Aclidinium Bromide (Anti-Cholinergic)

61L—43/Prasugrel Hydrochloride (Anti-Coagulant)

66W—04/Fingolimod Hydrochloride (Immunomodulator)

62Z—38/Apalutamide (Anti-neoplastic-Part II)

63E—35/Ivabradine (Cardiac Depressant)

63E—36/Ivabradine Hydrochloride (Cardiac Depressant)

63N—26/Amifampridine (Cholinergic)

63N—27/Amifampridine Phosphate (Cholinergic)

The Food and Drug Administration (FDA) will be editing a Center for Drug Evaluation and Research (CDER) Class Code under Industry Code 56. Class Code D will be changed from “Oligosaccharides” to “Aminoglycosides” because “aminoglycosides” is the currently accepted class name for the antibiotics in the class. The change is listed below and is effective immediately.

Class Code/Old Class Code Description/New Class Code Description

D/Oligosaccharides/Aminoglycosides

Furthermore, all the product code descriptions within Industry Code 56, Class D with “Oligosaccharides” will be revised to “Aminoglycosides.” The changes are listed below and are effective immediately.

Product Code/Old Description/New Description

56D—06/Amikacin Sulfate (Oligosaccharides)/ Amikacin Sulfate (Aminoglycosides)

56D—10/Dihydrostreptomycin (Oligosaccharides)/ Dihydrostreptomycin (Aminoglycosides)

56D—11/Dihydrostreptomycin Sulfate (Oligosaccharides)/ Dihydrostreptomycin Sulfate (Aminoglycosides)

56D—12/Dihydrostreptomycin Sulfate & HCl (Oligosaccharides)/ Dihydrostreptomycin Sulfate & HCl (Aminoglycosides)

56D—20/Gentamicin (Oligosaccharides)/ Gentamicin (Aminoglycosides)

56D—21/Gentamicin Sulfate (Oligosaccharides)/ Gentamicin Sulfate (Aminoglycosides)

56D—30/Kanamycin (Oligosaccharides)/ Kanamycin (Aminoglycosides)

56D—31/Kanamycin Sulfate (Oligosaccharides)/ Kanamycin Sulfate (Aminoglycosides)

56D—40/Neomycin (Oligosaccharides)/ Neomycin (Aminoglycosides)

56D—41/Neomycin Sulfate (Oligosaccharides)/ Neomycin Sulfate (Aminoglycosides)

56D—42/Neomycin Palmitate (Oligosaccharides)/ Neomycin Palmitate (Aminoglycosides)

56D—49/Neomycin, N.E.C. (Oligosaccharides)/ Neomycin, N.E.C. (Aminoglycosides)

56D—50/Paromomycin (Oligosaccharides)/ Paromomycin (Aminoglycosides)

56D—51/Paromomycin Sulfate (Oligosaccharides)/ Paromomycin Sulfate (Aminoglycosides)

56D—70/Streptomycin (Oligosaccharides)/ Streptomycin (Aminoglycosides)

56D—79/Streptomycin Sulfate (Oligosaccharides)/ Streptomycin Sulfate (Aminoglycosides)

56D—80/Tobramycin Sulfate (Oligosaccharides)/ Tobramycin Sulfate (Aminoglycosides)

56D—99/Oligosaccharides, N.E.C./ Aminoglycosides, N.E.C.

Please send any questions or concerns to the email address for the Product Code Builder Feedback: PCBFeedback@fda.hhs.gov

 
For assistance with product code identification, the public may also refer to the FDA Product Code Builder.