Prescription drug · NDA AUTHORIZED GENERIC
Isotretinoin NDC 57664-020
Isotretinoin 10 mg/1 · Capsule · Oral · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 57664-020-97 | 57664002097 | 3 BLISTER PACK in 1 BOX (57664-020-97) / 10 CAPSULE in 1 BLISTER PACK (57664-020-98)Marketed from Dec 29, 2020 |
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 — 10 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 021951
- Marketing start
- Listing expires
- Other FDA classes
- Retinoids (Chemical structure)
- Identifiers
- Product ID 57664-020_0e924cf6-5375-28c4-e063-6294a90a4ac4SPL ID 0e924cf6-5375-28c4-e063-6294a90a4ac4SPL set ID b44200ba-6672-4ea7-b151-7caec3f53c9cRxCUI 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
N457664002097followed by a unit qualifier and the quantityPackage 57664-0020-97. 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 therapy is needed, it is not recommended before a two-month waiting period because the patient’s acne may continue to improve following a 15 to 20-week course of therapy [see Dosage and Administration (2.2)…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 021951
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 |
|---|---|---|---|---|
| Absoricaisotretinoin | Isotretinoin 10 mg/1 | CapsuleOral | Sun Pharmaceutical Industries, Inc. | 10631-115 |
| Absoricaisotretinoin | Isotretinoin 20 mg/1 | CapsuleOral | Sun Pharmaceutical Industries, Inc. | 10631-116 |
| Absoricaisotretinoin | Isotretinoin 30 mg/1 | CapsuleOral | Sun Pharmaceutical Industries, Inc. | 10631-117 |
| Absoricaisotretinoin | Isotretinoin 40 mg/1 | CapsuleOral | Sun Pharmaceutical Industries, Inc. | 10631-118 |
| Absoricaisotretinoin | Isotretinoin 25 mg/1 | CapsuleOral | Sun Pharmaceutical Industries, Inc. | 10631-133 |
| Absoricaisotretinoin | Isotretinoin 35 mg/1 | CapsuleOral | Sun Pharmaceutical Industries, Inc. | 10631-134 |
| Isotretinoin | Isotretinoin 30 mg/1 | CapsuleOral | Sun Pharmaceutical Industries, Inc. | 57664-023 |
| Isotretinoin | Isotretinoin 20 mg/1 | CapsuleOral | Sun Pharmaceutical Industries, Inc. | 57664-021 |
| Isotretinoin | Isotretinoin 25 mg/1 | CapsuleOral | Sun Pharmaceutical Industries, Inc. | 57664-022 |
| Isotretinoin | Isotretinoin 35 mg/1 | CapsuleOral | Sun Pharmaceutical Industries, Inc. | 57664-024 |
| Isotretinoin | Isotretinoin 40 mg/1 | CapsuleOral | Sun Pharmaceutical Industries, Inc. | 57664-025 |