What is NDC 0054-0812?

0054-0812 is the product NDC for pyrazinamide, Pyrazinamide 500 mg/1 tablet, listed with the FDA by Hikma Pharmaceuticals USA Inc. It has 4 package NDCs, shown above in 10- and 11-digit form.

Hikma Pharmaceuticals USA Inc, NDC labeler code 0054. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

pyrazinamide NDC 0054-0812 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0054-0812Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00054-0812Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package
0054-0812-21	0005408122100054081221	60 TABLET in 1 CONTAINER (0054-0812-21)Marketed from Aug 30, 2024
0054-0812-22	0005408122200054081222	90 TABLET in 1 CONTAINER (0054-0812-22)Marketed from Aug 30, 2024
0054-0812-25	0005408122500054081225	100 TABLET in 1 CONTAINER (0054-0812-25)Marketed from Aug 30, 2024
0054-0812-29	0005408122900054081229	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
Labeler: Hikma Pharmaceuticals USA IncNDC labeler code 0054
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 081319
Marketing start: Aug 30, 2024
Listing expires: Dec 31, 2027
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

N400054081221 followed by a unit qualifier and the quantity

Package 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 Oct 3, 2023.

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.

Full label on DailyMed (opens in a new tab)

About NDC 0054-0812

What is NDC 0054-0812?: 0054-0812 is the product NDC for pyrazinamide, Pyrazinamide 500 mg/1 tablet, listed with the FDA by Hikma Pharmaceuticals USA Inc. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: pyrazinamide.
What is the active ingredient?: Pyrazinamide.
Who is the labeler?: Hikma Pharmaceuticals USA Inc, NDC labeler code 0054. 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other pyrazinamide NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Pyrazinamide	Pyrazinamide 500 mg/1	TabletOral	American Health Packaging	60687-789	60687-0789-01
Pyrazinamidepyrazinamide tablet	Pyrazinamide 500 mg/1	TabletOral	MARLEX PHARMACEUTICALS, INC	10135-735	10135-0735-0110135-0735-6010135-0735-90
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