Prescription drug · ANDA
Isotretinoin NDC 68308-571
Isotretinoin 20 mg/1 · Capsule, Liquid filled · Oral · Mayne Pharma
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68308-571-30 | 68308057130 | 3 BLISTER PACK in 1 BOX (68308-571-30) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (68308-571-01)Marketed from Sep 21, 2021 |
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 — 20 mg/1
- Dosage form
- Capsule, Liquid filled
- Route
- Oral
- Labeler
- Mayne Pharma
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212333
- Marketing start
- Listing expires
- Other FDA classes
- Retinoids (Chemical structure)
- Identifiers
- Product ID 68308-571_66d6a601-cb08-4662-a043-537a6f8d935bSPL ID 66d6a601-cb08-4662-a043-537a6f8d935bSPL set ID ebe1b3e3-1013-4cf6-bdc8-2baa3dc26e16RxCUI 197843, 197844, 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
N468308057130followed by a unit qualifier and the quantityPackage 68308-0571-30. 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. Isotretinoin capsules are retinoids 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 associat…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 212333
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 | Capsule, Liquid filledOral | Mayne Pharma | 68308-573 |
| Isotretinoin | Isotretinoin 10 mg/1 | Capsule, Liquid filledOral | Mayne Pharma | 68308-570 |
| Isotretinoin | Isotretinoin 10 mg/1 | Capsule, Liquid filledOral | Upsher-Smith Laboratories, LLC | 0245-0570 |
| Isotretinoin | Isotretinoin 20 mg/1 | Capsule, Liquid filledOral | Upsher-Smith Laboratories, LLC | 0245-0571 |
| Isotretinoin | Isotretinoin 30 mg/1 | Capsule, Liquid filledOral | Upsher-Smith Laboratories, LLC | 0245-0573 |