"0378-6614-93" National Drug Code (NDC)

Amnesteem 3 BLISTER PACK in 1 CARTON (0378-6614-93) > 10 CAPSULE in 1 BLISTER PACK (0378-6614-85)
(Mylan Pharmaceuticals Inc.)

NDC Code0378-6614-93
Package Description3 BLISTER PACK in 1 CARTON (0378-6614-93) > 10 CAPSULE in 1 BLISTER PACK (0378-6614-85)
Product NDC0378-6614
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameAmnesteem
Non-Proprietary NameIsotretinoin
Dosage FormCAPSULE
UsageORAL
Start Marketing Date20021111
Marketing Category NameANDA
Application NumberANDA075945
ManufacturerMylan Pharmaceuticals Inc.
Substance NameISOTRETINOIN
Strength40
Strength Unitmg/1
Pharmacy ClassesRetinoid [EPC], Retinoids [CS]

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