NDC 57664-025

Isotretinoin

Isotretinoin

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

Product ID57664-025_b44200ba-6672-4ea7-b151-7caec3f53c9c
NDC57664-025
Product TypeHuman Prescription Drug
Proprietary NameIsotretinoin
Generic NameIsotretinoin
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2020-12-29
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA021951
Labeler NameSun Pharmaceutical Industries, Inc.
Substance NameISOTRETINOIN
Active Ingredient Strength40 mg/1
Pharm ClassesRetinoid [EPC],Retinoids [CS]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 57664-025-97

3 BLISTER PACK in 1 BOX (57664-025-97) > 10 CAPSULE in 1 BLISTER PACK (57664-025-98)
Marketing Start Date2020-12-29
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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