Prescription drug · ANDA
Rifabutin NDC 70954-041
Rifabutin 150 mg/1 · Capsule · Oral · ANI Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70954-041-10 | 70954004110 | 100 CAPSULE in 1 BOTTLE (70954-041-10)Marketed from Dec 17, 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)
- Rifabutin
- Generic name (nonproprietary)
- rifabutin
- Active ingredients
- Rifabutin — 150 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- ANI Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215041
- Marketing start
- Listing expires
- Other FDA classes
- Rifamycins (Chemical structure)
- Identifiers
- Product ID 70954-041_cc04157f-1cc1-4f4a-a77f-9042a99e7825SPL ID cc04157f-1cc1-4f4a-a77f-9042a99e7825SPL set ID baf8ec98-bd0c-4b87-a7ee-813335431b89RxCUI 198200UNII 1W306TDA6SUPC 0370954041108
- Pharmacologic class
- Rifamycin Antimycobacterial
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
N470954004110followed by a unit qualifier and the quantityPackage 70954-0041-10. 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 .
Indications (excerpt from the label)
INDICATIONS & USAGE Rifabutin capsules are indicated for the prevention of disseminated Mycobacterium avium complex (MAC) disease in patients with advanced HIV infection.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 215041
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.