Prescription drug · NDA AUTHORIZED GENERIC
Rifabutin NDC 70518-4254
Rifabutin 150 mg/1 · Capsule · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-4254-0 | 7051842540070518425400 | 60 CAPSULE in 1 BOTTLE, PLASTIC (70518-4254-0)Marketed from Jan 13, 2025 |
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
- REMEDYREPACK INC.NDC labeler code 70518
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 050689
- Marketing start
- Listing expires
- Other FDA classes
- Rifamycins (Chemical structure)
- Identifiers
- Product ID 70518-4254_5a6f9607-503d-bcb7-e063-6394a90a67c6SPL ID 5a6f9607-503d-bcb7-e063-6394a90a67c6SPL set ID 25a60937-cbbe-4a50-994f-2ce15203f589RxCUI 198200UNII 1W306TDA6S
- 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
N470518425400followed by a unit qualifier and the quantityPackage 70518-4254-00. 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.
About NDC 70518-4254
- What is NDC 70518-4254?
- 70518-4254 is the product NDC for Rifabutin, Rifabutin 150 mg/1 capsule, listed with the FDA by REMEDYREPACK INC.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Rifabutin.
- What is the active ingredient?
- Rifabutin.
- Who is the labeler?
- REMEDYREPACK INC., NDC labeler code 70518. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Rifabutin?
- 5 other product NDCs are listed under this name. See all Rifabutin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Rifabutin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Rifabutin | Rifabutin 150 mg/1 | CapsuleOral | i3 Pharmaceuticals, LLC | 72319-010 | 72319-0010-04 |
| Rifabutin | Rifabutin 150 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4594 | 70518-4594-0070518-4594-01 |
| Rifabutin | Rifabutin 150 mg/1 | CapsuleOral | Marlex Pharmaceuticals, Inc. | 10135-738 | 10135-0738-01 |
| Rifabutin | Rifabutin 150 mg/1 | CapsuleOral | ANI Pharmaceuticals, Inc. | 70954-041 | 70954-0041-10 |
| Rifabutin | Rifabutin 150 mg/1 | CapsuleOral | Mylan Pharmaceuticals Inc. | 59762-1350 | 59762-1350-01 |
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 | Mylan Pharmaceuticals Inc. | 59762-1350 |