Prescription drug · ANDA
Isotretinoin NDC 68308-783
Isotretinoin 30 mg/1 · Capsule, Liquid filled · Oral · Mayne Pharma
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68308-783-30 | 68308078330 | 3 BLISTER PACK in 1 BOX (68308-783-30) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (68308-783-01)Marketed from Dec 1, 2023 |
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 — 30 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 076485
- Marketing start
- Listing expires
- Other FDA classes
- Retinoids (Chemical structure)
- Identifiers
- Product ID 68308-783_1bcfc61e-1b15-60e8-e063-6294a90ab074SPL ID 1bcfc61e-1b15-60e8-e063-6294a90ab074SPL set ID 0114567b-3bac-490d-b9eb-03a6c5d90935RxCUI 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
N468308078330followed by a unit qualifier and the quantityPackage 68308-0783-30. 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)
INDICATIONS AND USAGE Severe Recalcitrant Nodular Acne Isotretinoin capsules are indicated for the treatment of severe recalcitrant nodular acne. Nodules are inflammatory lesions with a diameter of 5 mm or greater. The nodules may become suppurative or hemorrhagic. "Severe," by definition, 2 means "many" as opposed to "few or several" nodules. Because of significant adverse effects associated with its use, isotretinoin capsules should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. In addition, isotretinoin capsules are indicated only for those patients who are not pregnant, because isotretinoin capsules can caus…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 076485
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 40 mg/1 | Capsule, Liquid filledOral | Upsher-Smith Laboratories, LLC | 0832-8304 |
| Isotretinoin | Isotretinoin 10 mg/1 | Capsule, Liquid filledOral | Mayne Pharma | 68308-781 |
| Isotretinoin | Isotretinoin 20 mg/1 | Capsule, Liquid filledOral | Mayne Pharma | 68308-782 |
| Isotretinoin | Isotretinoin 40 mg/1 | Capsule, Liquid filledOral | Mayne Pharma | 68308-784 |
| Isotretinoin | Isotretinoin 10 mg/1 | Capsule, Liquid filledOral | Upsher-Smith Laboratories, LLC | 0832-8301 |
| Isotretinoin | Isotretinoin 20 mg/1 | Capsule, Liquid filledOral | Upsher-Smith Laboratories, LLC | 0832-8302 |
| Isotretinoin | Isotretinoin 30 mg/1 | Capsule, Liquid filledOral | Upsher-Smith Laboratories, LLC | 0832-8303 |