NDC Active Ingredient Isotretinoin

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Active Ingredient Information

What is Isotretinoin?

A topical dermatologic agent that is used in the treatment of ACNE VULGARIS and several other skin diseases. The drug has teratogenic and other adverse effects.

What is the usage for Isotretinoin?

This medication is used to treat severe cystic acne (also known as nodular acne) that has not responded to other treatment (e.g., benzoyl peroxide or clindamycin applied to the skin or tetracycline or minocycline taken by mouth). It belongs to a class of drugs known as retinoids. It works by decreasing facial oil (sebum) production. High amounts of sebum can lead to severe acne. If left untreated, severe acne may cause permanent scarring.

How many products in the NDC database contain Isotretinoin?

The NDC database has 57 products with the active ingredient Isotretinoin. The following table lists all the products that have this active ingredient.

NDC Products with Isotretinoin

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Status
0245-0570Proprietary Name: Isotretinoin IsotretinoinCapsule, Liquid FilledOralUpsher-smith Laboratories, LlcACTIVE
0245-0571Proprietary Name: Isotretinoin IsotretinoinCapsule, Liquid FilledOralUpsher-smith Laboratories, LlcACTIVE
0245-0573Proprietary Name: Isotretinoin IsotretinoinCapsule, Liquid FilledOralUpsher-smith Laboratories, LlcACTIVE
0245-0575Proprietary Name: Isotretinoin IsotretinoinCapsule, Liquid FilledOralUpsher-smith Laboratories, LlcACTIVE
0378-6611Proprietary Name: Amnesteem IsotretinoinCapsuleOralMylan Pharmaceuticals Inc.ACTIVE
0378-6612Proprietary Name: Amnesteem IsotretinoinCapsuleOralMylan Pharmaceuticals Inc.ACTIVE
0378-6614Proprietary Name: Amnesteem IsotretinoinCapsuleOralMylan Pharmaceuticals Inc.ACTIVE
0555-1054Proprietary Name: Claravis IsotretinoinCapsule, Liquid FilledOralTeva Pharmaceuticals Usa, Inc.ACTIVE
0555-1055Proprietary Name: Claravis IsotretinoinCapsule, Liquid FilledOralTeva Pharmaceuticals Usa, Inc.ACTIVE
0555-1056Proprietary Name: Claravis IsotretinoinCapsule, Liquid FilledOralTeva Pharmaceuticals Usa, Inc.ACTIVE
0555-1057Proprietary Name: Claravis IsotretinoinCapsule, Liquid FilledOralTeva Pharmaceuticals Usa, Inc.ACTIVE
0591-2433Proprietary Name: Isotretinoin IsotretinoinCapsuleOralActavis Pharma, Inc.ACTIVE
0591-2434Proprietary Name: Isotretinoin IsotretinoinCapsuleOralActavis Pharma, Inc.ACTIVE
0591-2435Proprietary Name: Isotretinoin IsotretinoinCapsuleOralActavis Pharma, Inc.ACTIVE
0591-2436Proprietary Name: Isotretinoin IsotretinoinCapsuleOralActavis Pharma, Inc.ACTIVE
0591-2451Proprietary Name: Isotretinoin IsotretinoinCapsuleOralActavis Pharma, Inc.ACTIVE
0591-2501Proprietary Name: Isotretinoin IsotretinoinCapsuleOralActavis Pharma, Inc.ACTIVE
10631-002Proprietary Name: Absorica Ld IsotretinoinCapsuleOralSun Pharmaceutical Industries, Inc.ACTIVE
10631-003Proprietary Name: Absorica Ld IsotretinoinCapsuleOralSun Pharmaceutical Industries, Inc.ACTIVE
10631-005Proprietary Name: Absorica Ld IsotretinoinCapsuleOralSun Pharmaceutical Industries, Inc.ACTIVE
10631-007Proprietary Name: Absorica Ld IsotretinoinCapsuleOralSun Pharmaceutical Industries, Inc.ACTIVE
10631-115Proprietary Name: Absorica IsotretinoinCapsuleOralSun Pharmaceutical Industries, Inc.ACTIVE
10631-116Proprietary Name: Absorica IsotretinoinCapsuleOralSun Pharmaceutical Industries, Inc.ACTIVE
10631-117Proprietary Name: Absorica IsotretinoinCapsuleOralSun Pharmaceutical Industries, Inc.ACTIVE
10631-118Proprietary Name: Absorica IsotretinoinCapsuleOralSun Pharmaceutical Industries, Inc.ACTIVE
10631-133Proprietary Name: Absorica IsotretinoinCapsuleOralSun Pharmaceutical Industries, Inc.ACTIVE
10631-134Proprietary Name: Absorica IsotretinoinCapsuleOralSun Pharmaceutical Industries, Inc.ACTIVE
55111-113Proprietary Name: Zenatane IsotretinoinCapsule, Gelatin CoatedOralDr. Reddy's Laboratories LimitedACTIVE
55111-135Proprietary Name: Zenatane IsotretinoinCapsule, Gelatin CoatedOralDr. Reddy's Laboratories LimitedACTIVE
55111-136Proprietary Name: Zenatane IsotretinoinCapsule, Gelatin CoatedOralDr. Reddy's Laboratories LimitedACTIVE
55111-137Proprietary Name: Zenatane IsotretinoinCapsule, Gelatin CoatedOralDr. Reddy's Laboratories LimitedACTIVE
57664-020Proprietary Name: Isotretinoin IsotretinoinCapsuleOralSun Pharmaceutical Industries, Inc.ACTIVE
57664-021Proprietary Name: Isotretinoin IsotretinoinCapsuleOralSun Pharmaceutical Industries, Inc.ACTIVE
57664-022Proprietary Name: Isotretinoin IsotretinoinCapsuleOralSun Pharmaceutical Industries, Inc.ACTIVE
57664-023Proprietary Name: Isotretinoin IsotretinoinCapsuleOralSun Pharmaceutical Industries, Inc.ACTIVE
57664-024Proprietary Name: Isotretinoin IsotretinoinCapsuleOralSun Pharmaceutical Industries, Inc.ACTIVE
57664-025Proprietary Name: Isotretinoin IsotretinoinCapsuleOralSun Pharmaceutical Industries, Inc.ACTIVE
61748-301Proprietary Name: Myorisan IsotretinoinCapsule, Liquid FilledOralAkorn Operating Company LlcACTIVE
61748-302Proprietary Name: Myorisan IsotretinoinCapsule, Liquid FilledOralAkorn Operating Company LlcACTIVE
61748-303Proprietary Name: Myorisan IsotretinoinCapsule, Liquid FilledOralAkorn Operating Company LlcACTIVE
61748-304Proprietary Name: Myorisan IsotretinoinCapsule, Liquid FilledOralAkorn Operating Company LlcACTIVE
68308-570Proprietary Name: Isotretinoin IsotretinoinCapsule, Liquid FilledOralMayne PharmaACTIVE
68308-571Proprietary Name: Isotretinoin IsotretinoinCapsule, Liquid FilledOralMayne PharmaACTIVE
68308-573Proprietary Name: Isotretinoin IsotretinoinCapsule, Liquid FilledOralMayne PharmaACTIVE
68308-575Proprietary Name: Isotretinoin IsotretinoinCapsule, Liquid FilledOralMayne PharmaACTIVE
69238-1017Proprietary Name: Isotretinoin IsotretinoinCapsule, Liquid FilledOralAmneal Pharmaceuticals Ny LlcACTIVE
69238-1174Proprietary Name: Isotretinoin IsotretinoinCapsule, Liquid FilledOralAmneal Pharmaceuticals Ny LlcACTIVE
69238-1175Proprietary Name: Isotretinoin IsotretinoinCapsule, Liquid FilledOralAmneal Pharmaceuticals Ny LlcACTIVE
69238-1176Proprietary Name: Isotretinoin IsotretinoinCapsule, Liquid FilledOralAmneal Pharmaceuticals Ny LlcACTIVE
72143-231Proprietary Name: Accutane IsotretinoinCapsule, Gelatin CoatedOralJg Pharma Inc.ACTIVE
72143-232Proprietary Name: Accutane IsotretinoinCapsule, Gelatin CoatedOralJg Pharma Inc.ACTIVE
72143-233Proprietary Name: Accutane IsotretinoinCapsule, Gelatin CoatedOralJg Pharma Inc.ACTIVE
72143-234Proprietary Name: Accutane IsotretinoinCapsule, Gelatin CoatedOralJg Pharma Inc.ACTIVE
72143-251Proprietary Name: Accutane IsotretinoinCapsule, Gelatin CoatedOralJg Pharma Inc.ACTIVE
72143-252Proprietary Name: Accutane IsotretinoinCapsule, Gelatin CoatedOralJg Pharma Inc.ACTIVE
72143-253Proprietary Name: Accutane IsotretinoinCapsule, Gelatin CoatedOralJg Pharma Inc.ACTIVE
72143-254Proprietary Name: Accutane IsotretinoinCapsule, Gelatin CoatedOralJg Pharma Inc.ACTIVE
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