"84386-009-03" National Drug Code (NDC)

Isotretinoin 3 BLISTER PACK in 1 CARTON (84386-009-03) / 10 CAPSULE in 1 BLISTER PACK
(Aurobindo Pharma Limited)

NDC Code84386-009-03
Package Description3 BLISTER PACK in 1 CARTON (84386-009-03) / 10 CAPSULE in 1 BLISTER PACK
Product NDC84386-009
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameIsotretinoin
Non-Proprietary NameIsotretinoin
Dosage FormCAPSULE
UsageORAL
Start Marketing Date20260910
Marketing Category NameANDA
Application NumberANDA220336
ManufacturerAurobindo Pharma Limited
Substance NameISOTRETINOIN
Strength20
Strength Unitmg/1
Pharmacy ClassesRetinoid [EPC], Retinoids [CS]

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