Prescription drug · ANDA
Isotretinoin NDC 0591-2435
Isotretinoin 30 mg/1 · Capsule · Oral · Actavis Pharma, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0591-2435-15 | 0059124351500591243515 | 3 BLISTER PACK in 1 CARTON (0591-2435-15) / 10 CAPSULE in 1 BLISTER PACK (0591-2435-45)Marketed from Apr 29, 2021 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- Route
- Oral
- Labeler
- Actavis Pharma, Inc.NDC labeler code 0591
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205063
- Marketing start
- Listing expires
- Other FDA classes
- Retinoids (Chemical structure)
- Identifiers
- Product ID 0591-2435_96be4fff-bcb3-47d2-917d-df50320d7bbbSPL ID 96be4fff-bcb3-47d2-917d-df50320d7bbbSPL set ID 1cf11710-f966-4529-8e08-02175f588bcaRxCUI 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
N400591243515followed by a unit qualifier and the quantityPackage 00591-2435-15. 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.
About NDC 0591-2435
- What is NDC 0591-2435?
- 0591-2435 is the product NDC for Isotretinoin, Isotretinoin 30 mg/1 capsule, listed with the FDA by Actavis Pharma, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Isotretinoin.
- What is the active ingredient?
- Isotretinoin.
- Who is the labeler?
- Actavis Pharma, Inc., NDC labeler code 0591. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Isotretinoin?
- 66 other product NDCs are listed under this name. See all Isotretinoin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Isotretinoin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Isotretinoin | Isotretinoin 20 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 84386-009 | 84386-0009-03 |
| Isotretinoin | Isotretinoin 30 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 84386-010 | 84386-0010-03 |
| Isotretinoin | Isotretinoin 40 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 84386-011 | 84386-0011-03 |
| Isotretinoin | Isotretinoin 10 mg/1 | CapsuleOral | Amneal Pharmaceuticals NY LLC | 69238-1254 | 69238-1254-03 |
| Isotretinoin | Isotretinoin 20 mg/1 | CapsuleOral | Amneal Pharmaceuticals NY LLC | 69238-1255 | 69238-1255-03 |
| Isotretinoin | Isotretinoin 25 mg/1 | CapsuleOral | Amneal Pharmaceuticals NY LLC | 69238-1256 | 69238-1256-03 |
| Isotretinoin | Isotretinoin 30 mg/1 | CapsuleOral | Amneal Pharmaceuticals NY LLC | 69238-1257 | 69238-1257-03 |
| Isotretinoin | Isotretinoin 35 mg/1 | CapsuleOral | Amneal Pharmaceuticals NY LLC | 69238-1258 | 69238-1258-03 |
| Isotretinoin | Isotretinoin 40 mg/1 | CapsuleOral | Amneal Pharmaceuticals NY LLC | 69238-1259 | 69238-1259-03 |
| Isotretinoin | Isotretinoin 10 mg/1 | CapsuleOral | Zydus Pharmaceuticals USA Inc. | 70710-1574 | 70710-1574-08 |
Other NDCs under ANDA 205063
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 | Actavis Pharma, Inc. | 0591-2433 |
| Isotretinoin | Isotretinoin 20 mg/1 | CapsuleOral | Actavis Pharma, Inc. | 0591-2434 |
| Isotretinoin | Isotretinoin 40 mg/1 | CapsuleOral | Actavis Pharma, Inc. | 0591-2436 |
| Isotretinoin | Isotretinoin 25 mg/1 | CapsuleOral | Actavis Pharma, Inc. | 0591-2451 |
| Isotretinoin | Isotretinoin 35 mg/1 | CapsuleOral | Actavis Pharma, Inc. | 0591-2501 |