NDC codes

FDA NDC Directory
Product NDC (as listed)70954-484Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70954-0484Add 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 NDC11-digit (billing)PackageCopy
70954-484-10709540484107095404841060 TABLET in 1 BOTTLE (70954-484-10)Marketed from May 11, 2021
70954-484-20709540484207095404842090 TABLET in 1 BOTTLE (70954-484-20)Marketed from May 11, 2021
70954-484-307095404843070954048430100 TABLET in 1 BOTTLE (70954-484-30)Marketed from May 11, 2021

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
ANI Pharmaceuticals, Inc.NDC labeler code 70954
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 080157
Marketing start
Listing expires
Identifiers
Product ID 70954-484_e043f21d-4a30-4d23-bc03-12207af7d6d7SPL ID e043f21d-4a30-4d23-bc03-12207af7d6d7SPL set ID 262d8829-728c-48db-b89b-88d13b87e684RxCUI 198181UNII 2KNI5N06TIUPC 0370954484103, 0370954484301, 0370954484202
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

N470954048410 followed by a unit qualifier and the quantity

Package 70954-0484-10. 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 & 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 current …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 70954-484

What is NDC 70954-484?
70954-484 is the product NDC for Pyrazinamide, Pyrazinamide 500 mg/1 tablet, listed with the FDA by ANI Pharmaceuticals, Inc.. It has 3 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?
ANI Pharmaceuticals, Inc., NDC labeler code 70954. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
pyrazinamidePyrazinamide 500 mg/1TabletOralHikma Pharmaceuticals USA Inc0054-081200054-0812-2100054-0812-2200054-0812-25+1 more
PyrazinamidePyrazinamide 500 mg/1TabletOralAmerican Health Packaging60687-78960687-0789-01
Pyrazinamidepyrazinamide tabletPyrazinamide 500 mg/1TabletOralMARLEX PHARMACEUTICALS, INC10135-73510135-0735-0110135-0735-6010135-0735-90
PyrazinamidePyrazinamide 500 mg/1TabletOralMacleods Pharmaceuticals Limited33342-44733342-0447-0333342-0447-0733342-0447-09+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.

FDA NDC Directory listings under ANDA 080157
ProductStrengthForm · routeLabelerProduct NDC
Pyrazinamidepyrazinamide tabletPyrazinamide 500 mg/1TabletOralMARLEX PHARMACEUTICALS, INC10135-735
PyrazinamidePyrazinamide 500 mg/1TabletOralAmerican Health Packaging60687-789

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