Prescription drug · ANDA
Isotretinoin NDC 70771-1557
Isotretinoin 10 mg/1 · Capsule · Oral · Zydus Lifesciences Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70771-1557-4 | 70771155704 | 10 BLISTER PACK in 1 CARTON (70771-1557-4) / 10 CAPSULE in 1 BLISTER PACKMarketed from Sep 12, 2023 | |
| 70771-1557-8 | 70771155708 | 3 BLISTER PACK in 1 CARTON (70771-1557-8) / 10 CAPSULE in 1 BLISTER PACKMarketed from Sep 12, 2023 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Isotretinoin
- Generic name (nonproprietary)
- isotretinoin
- Active ingredients
- Isotretinoin — 10 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Zydus Lifesciences Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211568
- Marketing start
- Listing expires
- Other FDA classes
- Retinoids (Chemical structure)
- Identifiers
- Product ID 70771-1557_b071eb5c-28f7-4b86-b4e9-7c98da2f19dfSPL ID b071eb5c-28f7-4b86-b4e9-7c98da2f19dfSPL set ID dae33df0-386c-4db5-9759-7096e770ed17RxCUI 197843, 197844, 197845, 403930UNII EH28UP18IF
- Pharmacologic class
- Retinoid
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N470771155704followed by a unit qualifier and the quantityPackage 70771-1557-04. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Other NDCs under ANDA 211568
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Isotretinoin | Isotretinoin 10 mg/1 | CapsuleOral | Zydus Pharmaceuticals USA Inc. | 70710-1022 |
| Isotretinoin | Isotretinoin 40 mg/1 | CapsuleOral | Zydus Pharmaceuticals USA Inc. | 70710-1025 |
| Isotretinoin | Isotretinoin 20 mg/1 | CapsuleOral | Zydus Pharmaceuticals USA Inc. | 70710-1023 |
| Isotretinoin | Isotretinoin 30 mg/1 | CapsuleOral | Zydus Pharmaceuticals USA Inc. | 70710-1024 |
| Isotretinoin | Isotretinoin 20 mg/1 | CapsuleOral | Zydus Lifesciences Limited | 70771-1558 |
| Isotretinoin | Isotretinoin 30 mg/1 | CapsuleOral | Zydus Lifesciences Limited | 70771-1559 |
| Isotretinoin | Isotretinoin 40 mg/1 | CapsuleOral | Zydus Lifesciences Limited | 70771-1560 |