Prescription drug · ANDA
Rifabutin NDC 72319-010
Rifabutin 150 mg/1 · Capsule · Oral · i3 Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72319-010-04 | 7231900100472319001004 | 100 CAPSULE in 1 BOTTLE (72319-010-04)Marketed from Apr 16, 2026 |
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
- i3 Pharmaceuticals, LLCNDC labeler code 72319
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212430
- Marketing start
- Listing expires
- Other FDA classes
- Rifamycins (Chemical structure)
- Identifiers
- Product ID 72319-010_4efa116e-c5b0-d87e-e063-6394a90a5077SPL ID 4efa116e-c5b0-d87e-e063-6394a90a5077SPL set ID fd6062e2-17c8-48f4-a1fe-69ebe410f583RxCUI 198200UNII 1W306TDA6SUPC 0372319010040
- 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
N472319001004followed by a unit qualifier and the quantityPackage 72319-0010-04. 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 72319-010
- What is NDC 72319-010?
- 72319-010 is the product NDC for Rifabutin, Rifabutin 150 mg/1 capsule, listed with the FDA by i3 Pharmaceuticals, LLC. 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?
- i3 Pharmaceuticals, LLC, NDC labeler code 72319. 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 | 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 | ANI Pharmaceuticals, Inc. | 70954-041 | 70954-0041-10 |
| Rifabutin | Rifabutin 150 mg/1 | CapsuleOral | Mylan Pharmaceuticals Inc. | 59762-1350 | 59762-1350-01 |