Prescription drug · ANDA
Isotretinoin NDC 59651-635
Isotretinoin 35 mg/1 · Capsule · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59651-635-03 | 59651063503 | 3 BLISTER PACK in 1 CARTON (59651-635-03) / 10 CAPSULE in 1 BLISTER PACKMarketed from Jan 29, 2024 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 — 35 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Aurobindo Pharma Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218194
- Marketing start
- Listing expires
- Other FDA classes
- Retinoids (Chemical structure)
- Identifiers
- Product ID 59651-635_d7966cd2-9b7b-4a4e-bbcf-4be07461df60SPL ID d7966cd2-9b7b-4a4e-bbcf-4be07461df60SPL set ID 4e8516dc-a3c6-4d8f-aa14-2c37c6c8f6e6RxCUI 197843, 197844, 197845, 403930, 1547561, 1547565UNII 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
N459651063503followed by a unit qualifier and the quantityPackage 59651-0635-03. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
Isotretinoin capsules are indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. Because of significant adverse reactions associated with its use, isotretinoin capsules are reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. Limitations of Use If a second course of isotretinoin capsules treatment is needed, it is not recommended before a 2-month waiting period because the patient’s acne may continue to improve following a 15 to 20-week course of treatment [see Dosage and Administration (2.2)…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 218194
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 30 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 59651-634 |
| Isotretinoin | Isotretinoin 10 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 59651-631 |
| Isotretinoin | Isotretinoin 20 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 59651-632 |
| Isotretinoin | Isotretinoin 25 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 59651-633 |
| Isotretinoin | Isotretinoin 40 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 59651-636 |