NDC 0591-2434

Isotretinoin

Isotretinoin

Isotretinoin is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Actavis Pharma, Inc.. The primary component is Isotretinoin.

Product ID0591-2434_ff870db3-ca93-4f91-a0ed-e529d83c16d4
NDC0591-2434
Product TypeHuman Prescription Drug
Proprietary NameIsotretinoin
Generic NameIsotretinoin
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2021-04-29
Marketing CategoryANDA /
Application NumberANDA205063
Labeler NameActavis Pharma, Inc.
Substance NameISOTRETINOIN
Active Ingredient Strength20 mg/1
Pharm ClassesRetinoid [EPC],Retinoids [CS]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0591-2434-15

3 BLISTER PACK in 1 CARTON (0591-2434-15) > 10 CAPSULE in 1 BLISTER PACK (0591-2434-45)
Marketing Start Date2021-04-29
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Isotretinoin" or generic name "Isotretinoin"

NDCBrand NameGeneric Name
0245-0570IsotretinoinIsotretinoin
0245-0571IsotretinoinIsotretinoin
0245-0573IsotretinoinIsotretinoin
0245-0575IsotretinoinIsotretinoin
69238-1017IsotretinoinIsotretinoin
69238-1174IsotretinoinIsotretinoin
69238-1175IsotretinoinIsotretinoin
69238-1176IsotretinoinIsotretinoin
57664-021IsotretinoinIsotretinoin
57664-023IsotretinoinIsotretinoin
57664-025IsotretinoinIsotretinoin
57664-020IsotretinoinIsotretinoin
57664-022IsotretinoinIsotretinoin
57664-024IsotretinoinIsotretinoin
0378-6611Amnesteemisotretinoin
0378-6612Amnesteemisotretinoin
0378-6614Amnesteemisotretinoin
0555-1054ClaravisIsotretinoin
0555-1055ClaravisIsotretinoin
0555-1056ClaravisIsotretinoin
0555-1057ClaravisIsotretinoin
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