Prescription drug · ANDA
Pyrazinamide NDC 60687-789
Pyrazinamide 500 mg/1 · Tablet · Oral · American Health Packaging
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60687-789-01 | 60687078901 | 100 BLISTER PACK in 1 CARTON (60687-789-01) / 1 TABLET in 1 BLISTER PACK (60687-789-11)Marketed from Feb 20, 2024 |
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
- Active ingredients
- Pyrazinamide — 500 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- American Health Packaging
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 080157
- Marketing start
- Listing expires
- Identifiers
- Product ID 60687-789_437ec08f-b9a1-9235-e063-6394a90a5beeSPL ID 437ec08f-b9a1-9235-e063-6394a90a5beeSPL set ID e2dbbdf9-ddfd-4d6d-ad42-6e658969f11eRxCUI 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
N460687078901followed by a unit qualifier and the quantityPackage 60687-0789-01. 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.
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 | ANI Pharmaceuticals, Inc. | 70954-484 |
| Pyrazinamidepyrazinamide tablet | Pyrazinamide 500 mg/1 | TabletOral | MARLEX PHARMACEUTICALS, INC | 10135-735 |