Prescription drug · ANDA
pyrazinamide NDC 0054-0812
Pyrazinamide 500 mg/1 · Tablet · Oral · Hikma Pharmaceuticals USA Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0054-0812-21 | 00054081221 | 60 TABLET in 1 CONTAINER (0054-0812-21)Marketed from Aug 30, 2024 | |
| 0054-0812-22 | 00054081222 | 90 TABLET in 1 CONTAINER (0054-0812-22)Marketed from Aug 30, 2024 | |
| 0054-0812-25 | 00054081225 | 100 TABLET in 1 CONTAINER (0054-0812-25)Marketed from Aug 30, 2024 | |
| 0054-0812-29 | 00054081229 | 500 TABLET in 1 CONTAINER (0054-0812-29)Marketed from Aug 30, 2024 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 081319
- Marketing start
- Listing expires
- Identifiers
- Product ID 0054-0812_05eb3847-557f-460c-951f-e614fb9f9045SPL ID 05eb3847-557f-460c-951f-e614fb9f9045SPL set ID 566db230-3d73-482f-b67d-defd0b2dc46cRxCUI 198181UNII 2KNI5N06TIUPC 0300540812218
- 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
N400054081221followed by a unit qualifier and the quantityPackage 00054-0812-21. 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.