"54868-5039-0" National Drug Code (NDC)

Amnesteem 3 BLISTER PACK in 1 CARTON (54868-5039-0) > 10 CAPSULE in 1 BLISTER PACK
(Physicians Total Care, Inc.)

NDC Code54868-5039-0
Package Description3 BLISTER PACK in 1 CARTON (54868-5039-0) > 10 CAPSULE in 1 BLISTER PACK
Product NDC54868-5039
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameAmnesteem
Non-Proprietary NameIsotretinoin
Dosage FormCAPSULE
UsageORAL
Start Marketing Date20101102
Marketing Category NameANDA
Application NumberANDA075945
ManufacturerPhysicians Total Care, Inc.
Substance NameISOTRETINOIN
Strength10
Strength Unitmg/1
Pharmacy ClassesRetinoid [EPC],Retinoids [Chemical/Ingredient]

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