Prescription drug · NDA AUTHORIZED GENERIC
Rifabutin NDC 59762-1350
Rifabutin 150 mg/1 · Capsule · Oral · Mylan Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59762-1350-1 | 59762135001 | 100 CAPSULE in 1 BOTTLE (59762-1350-1)Marketed from Apr 7, 2014 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Mylan Pharmaceuticals Inc.
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 050689
- Marketing start
- Listing expires
- Other FDA classes
- Rifamycins (Chemical structure)
- Identifiers
- Product ID 59762-1350_acc8cbc0-0202-43e3-a1c2-cc6d960dbb37SPL ID acc8cbc0-0202-43e3-a1c2-cc6d960dbb37SPL set ID c2026b67-4755-4236-96b6-a6b5e7399707RxCUI 198200UNII 1W306TDA6SUPC 0359762135018
- 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
N459762135001followed by a unit qualifier and the quantityPackage 59762-1350-01. 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 AND 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 NDA 050689
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 |
|---|---|---|---|---|
| Rifabutin | Rifabutin 150 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4254 |