NDC 68308-573

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 ID68308-573_66d6a601-cb08-4662-a043-537a6f8d935b
NDC68308-573
Product TypeHuman Prescription Drug
Proprietary NameIsotretinoin
Generic NameIsotretinoin
Dosage FormCapsule, Liquid Filled
Route of AdministrationORAL
Marketing Start Date2021-09-21
Marketing CategoryANDA /
Application NumberANDA212333
Labeler NameMayne Pharma
Substance NameISOTRETINOIN
Active Ingredient Strength30 mg/1
Pharm ClassesRetinoid [EPC], Retinoids [CS]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 68308-573-30

3 BLISTER PACK in 1 BOX (68308-573-30) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (68308-573-01)
Marketing Start Date2021-09-21
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
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.