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 | 7095400411070954004110 | 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.NDC labeler code 70954
- 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_c5242fe5-fd64-4961-a19b-d9a67c9a767dSPL ID c5242fe5-fd64-4961-a19b-d9a67c9a767d
- 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 70954-041
- What is NDC 70954-041?
- 70954-041 is the product NDC for Rifabutin, Rifabutin 150 mg/1 capsule, listed with the FDA by ANI Pharmaceuticals, 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?
- ANI Pharmaceuticals, Inc., NDC labeler code 70954. 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 | REMEDYREPACK INC. | 70518-4254 | 70518-4254-00 |
| Rifabutin | Rifabutin 150 mg/1 | CapsuleOral | Marlex Pharmaceuticals, Inc. | 10135-738 | 10135-0738-01 |
| Rifabutin | Rifabutin 150 mg/1 | CapsuleOral | Mylan Pharmaceuticals Inc. | 59762-1350 | 59762-1350-01 |
Other NDCs under ANDA 215041
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 | Marlex Pharmaceuticals, Inc. | 10135-738 |
| Rifabutin | Rifabutin 150 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4594 |