Drug
Isotretinoin NDC Codes
Isotretinoin is listed in the FDA NDC Directory as 67 finished products from 11 labelers.
Overview
Active ingredient: Isotretinoin. Each product below links to its own NDC page with package NDCs in 10- and 11-digit form.
- Generic name
- Isotretinoin
- Active ingredients
- Isotretinoin
- Labelers
- Zydus Lifesciences Limited, Zydus Pharmaceuticals USA Inc., Mayne Pharma, Amneal Pharmaceuticals NY LLC, Aurobindo Pharma Limited, Actavis Pharma, Inc., Sun Pharmaceutical Industries, Inc., Upsher-Smith Laboratories, LLC, Amneal Pharmaceuticals LLC, Upsher-Smith Laboratories, LLC
- Strengths
- Isotretinoin 20 mg/1; Isotretinoin 30 mg/1; Isotretinoin 40 mg/1; Isotretinoin 10 mg/1; Isotretinoin 25 mg/1; Isotretinoin 35 mg/1
- Dosage forms
- Capsule, Capsule, Liquid filled
- Routes
- Oral
- Drug classes (FDA established)
- Retinoid
- HCPCS / J-code
- None in Med-Code's directory for these products
- Package NDCs
- 73
NDC codes
Newest listings first. Each row links to the product’s NDC page.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) | HCPCS |
|---|---|---|---|---|---|---|
| Isotretinoin | Isotretinoin 20 mg/1 | CapsuleOral | Sun Pharmaceutical Industries, Inc. | 57664-021 | 57664-0021-97 | — |
| Isotretinoin | Isotretinoin 25 mg/1 | CapsuleOral | Sun Pharmaceutical Industries, Inc. | 57664-022 | 57664-0022-97 | — |
| Isotretinoin | Isotretinoin 30 mg/1 | CapsuleOral | Sun Pharmaceutical Industries, Inc. | 57664-023 | 57664-0023-97 | — |
| Isotretinoin | Isotretinoin 35 mg/1 | CapsuleOral | Sun Pharmaceutical Industries, Inc. | 57664-024 | 57664-0024-97 | — |
| Isotretinoin | Isotretinoin 40 mg/1 | CapsuleOral | Sun Pharmaceutical Industries, Inc. | 57664-025 | 57664-0025-97 | — |
| Isotretinoin | Isotretinoin 30 mg/1 | Capsule, Liquid filledOral | Amneal Pharmaceuticals LLC | 69238-1017 | 69238-1017-03 | — |
| Isotretinoin | Isotretinoin 10 mg/1 | Capsule, Liquid filledOral | Amneal Pharmaceuticals LLC | 69238-1174 | 69238-1174-03 | — |
| Isotretinoin | Isotretinoin 20 mg/1 | Capsule, Liquid filledOral | Amneal Pharmaceuticals LLC | 69238-1175 | 69238-1175-03 | — |
| Isotretinoin | Isotretinoin 40 mg/1 | Capsule, Liquid filledOral | Amneal Pharmaceuticals LLC | 69238-1176 | 69238-1176-03 | — |
| Isotretinoin | Isotretinoin 30 mg/1 | Capsule, Liquid filledOral | Upsher-Smith Laboratories, LLC | 0832-8303 | 00832-8303-30 | — |
| Isotretinoin | Isotretinoin 10 mg/1 | Capsule, Liquid filledOral | Upsher-Smith Laboratories, LLC | 0832-8301 | 00832-8301-30 | — |
| Isotretinoin | Isotretinoin 20 mg/1 | Capsule, Liquid filledOral | Upsher-Smith Laboratories, LLC | 0832-8302 | 00832-8302-30 | — |
| Isotretinoin | Isotretinoin 40 mg/1 | Capsule, Liquid filledOral | Upsher-Smith Laboratories, LLC | 0832-8304 | 00832-8304-30 | — |
| Isotretinoin | Isotretinoin 10 mg/1 | Capsule, Liquid filledOral | Mayne Pharma | 68308-781 | 68308-0781-30 | — |
| Isotretinoin | Isotretinoin 20 mg/1 | Capsule, Liquid filledOral | Mayne Pharma | 68308-782 | 68308-0782-30 | — |
| Isotretinoin | Isotretinoin 30 mg/1 | Capsule, Liquid filledOral | Mayne Pharma | 68308-783 | 68308-0783-30 | — |
| Isotretinoin | Isotretinoin 40 mg/1 | Capsule, Liquid filledOral | Mayne Pharma | 68308-784 | 68308-0784-30 | — |
Isotretinoin: common questions
- What is the NDC for Isotretinoin?
- Isotretinoin has 67 product NDCs, one for each strength, dosage form and labeler; each product NDC then has one package NDC per package size. Pick the row for your product above to see its package NDCs.
- Is there a J-code for Isotretinoin?
- Med-Code's curated HCPCS directory has no drug-specific code for these products. Drugs dispensed by a pharmacy are billed by NDC. NDC vs J-code.
- Which NDC goes on a claim?
- The package NDC of what was given, in 11-digit form. How to convert a 10-digit NDC.