NDC 68308-575

Isotretinoin

Isotretinoin

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

Product ID68308-575_52056651-f1ce-4586-9c28-f919591060a4
NDC68308-575
Product TypeHuman Prescription Drug
Proprietary NameIsotretinoin
Generic NameIsotretinoin
Dosage FormCapsule, Liquid Filled
Route of AdministrationORAL
Marketing Start Date2021-09-03
Marketing CategoryANDA /
Application NumberANDA213571
Labeler NameMayne Pharma
Substance NameISOTRETINOIN
Active Ingredient Strength40 mg/1
Pharm ClassesRetinoid [EPC], Retinoids [CS]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 68308-575-30

3 BLISTER PACK in 1 BOX (68308-575-30) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (68308-575-01)
Marketing Start Date2021-09-03
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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