Prescription drug · ANDA
Rifapentine NDC 33342-599
Rifapentine 150 mg/1 · Tablet, Film coated · Oral · Macleods Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 33342-599-54 | 33342059954 | 3 BLISTER PACK in 1 CARTON (33342-599-54) / 8 TABLET, FILM COATED in 1 BLISTER PACK (33342-599-20)Marketed from Jun 23, 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)
- Rifapentine
- Generic name (nonproprietary)
- rifapentine
- Active ingredients
- Rifapentine — 150 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Macleods Pharmaceuticals LimitedNDC labeler code 33342
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217042
- Marketing start
- Listing expires
- Other FDA classes
- Rifamycins (Chemical structure)
- Identifiers
- Product ID 33342-599_f95d726e-5a09-48dd-b719-e4400fb91c8fSPL ID f95d726e-5a09-48dd-b719-e4400fb91c8fSPL set ID f95d726e-5a09-48dd-b719-e4400fb91c8fRxCUI 242671UNII XJM390A33U
- 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
N433342059954followed by a unit qualifier and the quantityPackage 33342-0599-54. 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)
• Rifapentine tablets are a rifamycin antimycobacterial drug indicated in patients 12 years of age and older for the treatment of active pulmonary tuberculosis (TB) caused by Mycobacterium tuberculosis in combination with one or more antituberculosis (anti-TB) drugs to which the isolate is susceptible. ( 1.1 ) • Rifapentine tablets are indicated for the treatment of latent tuberculosis infection (LTBI) caused by M. tuberculosis in combination with isoniazid in patients 2 years of age and older at high risk of progression to TB disease. ( 1.2 ) • See Full Prescribing Information for Limitations of Use. ( 1.1 , 1.2 ) 1.1 Active Pulmonary Tuberculosis Rifapentine tablets are indicated in adults…
Excerpt only. Read the full label for complete information.
About NDC 33342-599
- What is NDC 33342-599?
- 33342-599 is the product NDC for Rifapentine, Rifapentine 150 mg/1 tablet, film coated, listed with the FDA by Macleods Pharmaceuticals Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Rifapentine.
- What is the active ingredient?
- Rifapentine.
- Who is the labeler?
- Macleods Pharmaceuticals Limited, NDC labeler code 33342. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Rifapentine?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.