Prescription drug · ANDA
Claravis (isotretinoin) NDC 0555-1057
Isotretinoin 40 mg/1 · Capsule, Liquid filled · Oral · Teva Pharmaceuticals USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0555-1057-56 | 00555105756 | 10 BLISTER PACK in 1 CARTON (0555-1057-56) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0555-1057-60)Marketed from May 9, 2003 | |
| 0555-1057-86 | 00555105786 | 3 BLISTER PACK in 1 CARTON (0555-1057-86) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0555-1057-60)Marketed from May 9, 2003 |
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)
- Claravis
- Generic name (nonproprietary)
- isotretinoin
- Active ingredients
- Isotretinoin — 40 mg/1
- Dosage form
- Capsule, Liquid filled
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076135
- Marketing start
- Listing expires
- Other FDA classes
- Retinoids (Chemical structure)
- Identifiers
- Product ID 0555-1057_0ace332b-58a2-4b31-86ae-a00bfd3361d4SPL ID 0ace332b-58a2-4b31-86ae-a00bfd3361d4SPL set ID a31fd109-d0fd-4ab9-ba98-a3d64333c18dRxCUI 197843, 197844, 197845, 403930, 404059, 404062, 404065, 643488UNII 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
N400555105756followed by a unit qualifier and the quantityPackage 00555-1057-56. 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)
Claravis ™ (isotretinoin capsules USP) is 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, Claravis is reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. Limitations of Use : If a second course of Claravis treatment 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 treatment [see Dosage and Administration ( 2.2 )]. Cl…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 076135
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.