NDC 0245-0575

Isotretinoin

Isotretinoin

Isotretinoin is a Oral Capsule, Liquid Filled in the Human Prescription Drug category. It is labeled and distributed by Upsher-smith Laboratories, Llc. The primary component is Isotretinoin.

Product ID0245-0575_13b40598-a591-442c-b0ae-56b09c61a3cb
NDC0245-0575
Product TypeHuman Prescription Drug
Proprietary NameIsotretinoin
Generic NameIsotretinoin
Dosage FormCapsule, Liquid Filled
Route of AdministrationORAL
Marketing Start Date2021-04-12
Marketing CategoryANDA /
Application NumberANDA213571
Labeler NameUpsher-Smith Laboratories, LLC
Substance NameISOTRETINOIN
Active Ingredient Strength40 mg/1
Pharm ClassesRetinoid [EPC],Retinoids [CS]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0245-0575-01

3 BLISTER PACK in 1 BOX (0245-0575-01) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0245-0575-89)
Marketing Start Date2021-06-25
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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