Prescription drug · ANDA
Pyrazinamide (Pyrazinamide tablet) NDC 10135-735
Pyrazinamide 500 mg/1 · Tablet · Oral · MARLEX PHARMACEUTICALS, INC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 10135-735-01 | 1013507350110135073501 | 100 TABLET in 1 BOTTLE (10135-735-01)Marketed from Mar 1, 2022 | |
| 10135-735-60 | 1013507356010135073560 | 60 TABLET in 1 BOTTLE (10135-735-60)Marketed from Mar 1, 2022 | |
| 10135-735-90 | 1013507359010135073590 | 90 TABLET in 1 BOTTLE (10135-735-90)Marketed from Mar 1, 2022 |
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)
- Pyrazinamide
- Generic name (nonproprietary)
- pyrazinamide tablet
- Active ingredients
- Pyrazinamide — 500 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- MARLEX PHARMACEUTICALS, INCNDC labeler code 10135
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 080157
- Marketing start
- Listing expires
- Identifiers
- Product ID 10135-735_45222685-8d74-a7e1-e063-6294a90a9945SPL ID 45222685-8d74-a7e1-e063-6294a90a9945SPL set ID db250a85-2e20-87e9-e053-2a95a90a72b6RxCUI 198181UNII 2KNI5N06TI
- Pharmacologic class
- 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
N410135073501followed by a unit qualifier and the quantityPackage 10135-0735-01. 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 Pyrazinamide is indicated for the initial treatment of active tuberculosis in adults and children when combined with other antituberculous agents. (The current recommendation of the CDC for drug-susceptible disease is to use a six-month regimen for initial treatment of active tuberculosis, consisting of isoniazid, rifampin and pyrazinamide given for 2 months, followed by isoniazid and rifampin for 4 months. *4 ) (Patients with drug-resistant disease should be treated with regimens individualized to their situation. Pyrazinamide frequently will be an important component of such therapy.) (In patients with concomitant HIV infection, the physician should be aware of curren…
Excerpt only. Read the full label for complete information.
About NDC 10135-735
- What is NDC 10135-735?
- 10135-735 is the product NDC for Pyrazinamide (pyrazinamide tablet), Pyrazinamide 500 mg/1 tablet, listed with the FDA by MARLEX PHARMACEUTICALS, INC. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Pyrazinamide (Pyrazinamide tablet).
- What is the active ingredient?
- Pyrazinamide.
- Who is the labeler?
- MARLEX PHARMACEUTICALS, INC, NDC labeler code 10135. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Pyrazinamide?
- 4 other product NDCs are listed under this name. See all Pyrazinamide NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Pyrazinamide products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| pyrazinamide | Pyrazinamide 500 mg/1 | TabletOral | Hikma Pharmaceuticals USA Inc | 0054-0812 | 00054-0812-2100054-0812-2200054-0812-25+1 more |
| Pyrazinamide | Pyrazinamide 500 mg/1 | TabletOral | American Health Packaging | 60687-789 | 60687-0789-01 |
| Pyrazinamide | Pyrazinamide 500 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 70954-484 | 70954-0484-1070954-0484-2070954-0484-30 |
| Pyrazinamide | Pyrazinamide 500 mg/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-447 | 33342-0447-0333342-0447-0733342-0447-09+4 more |
Other NDCs under ANDA 080157
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 |
|---|---|---|---|---|
| Pyrazinamide | Pyrazinamide 500 mg/1 | TabletOral | American Health Packaging | 60687-789 |
| Pyrazinamide | Pyrazinamide 500 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 70954-484 |