Prescription drug · ANDA
rifampin NDC 0904-7315
Rifampin 300 mg/1 · Capsule · Oral · Major Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0904-7315-61 | 00904731561 | 100 BLISTER PACK in 1 CARTON (0904-7315-61) / 1 CAPSULE in 1 BLISTER PACKMarketed from Feb 25, 2025 |
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)
- rifampin
- Generic name (nonproprietary)
- rifampin
- Active ingredients
- Rifampin — 300 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Major Pharmaceuticals
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090034
- Marketing start
- Listing expires
- Other FDA classes
- Rifamycins (Chemical structure)
- Identifiers
- Product ID 0904-7315_de94fe08-b966-4803-b90e-0455f3955a7eSPL ID de94fe08-b966-4803-b90e-0455f3955a7eSPL set ID 3f3534c1-95e4-4bdd-b044-9026e4addf0cRxCUI 198202UNII VJT6J7R4TR
- Pharmacologic class
- Rifamycin Antibacterial
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
N400904731561followed by a unit qualifier and the quantityPackage 00904-7315-61. 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 In the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. Bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to rifampin and they should be repeated throughout therapy to monitor the response to treatment. Since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. If test results show resistance to rifampin and the patient is not responding to therapy, the drug regim…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 090034
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 |
|---|---|---|---|---|
| rifampin | Rifampin 300 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2613 |
| rifampin | Rifampin 150 mg/1 | CapsuleOral | Lupin Pharmaceuticals, Inc. | 68180-658 |
| Rifampin | Rifampin 150 mg/1 | CapsuleOral | American Health Packaging | 60687-575 |
| rifampin | Rifampin 300 mg/1 | CapsuleOral | Lupin Pharmaceuticals, Inc. | 68180-659 |
| Rifampin | Rifampin 300 mg/1 | CapsuleOral | American Health Packaging | 60687-586 |
| rifampin | Rifampin 300 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-5709 |