What is NDC 44523-450?

44523-450 is the product NDC for Tinidazole, Tinidazole 500 mg/1 tablet, film coated, listed with the FDA by BioComp Pharma, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

BioComp Pharma, Inc., NDC labeler code 44523. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Tinidazole?

7 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Tinidazole NDC 44523-450 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)44523-450Labeler and product segments. Claims need a package NDC.

Product NDC at billing width44523-0450Add 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	Copy
44523-450-12	44523045012	12 TABLET, FILM COATED in 1 BOTTLE (44523-450-12)Marketed from Mar 20, 2025
44523-450-20	44523045020	20 TABLET, FILM COATED in 1 BOTTLE (44523-450-20)Marketed from Mar 20, 2025

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): Tinidazole
Generic name (nonproprietary): tinidazole
Active ingredients: Tinidazole — 500 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: BioComp Pharma, Inc.NDC labeler code 44523
Product type: Prescription drug
Marketing category: NDA authorized genericApplication NDA 021618
Marketing start: Mar 20, 2025
Listing expires: Dec 31, 2026
Other FDA classes: Nitroimidazoles (Chemical structure)
Identifiers: Product ID 44523-450_44ecbffa-e4aa-9dd3-e063-6394a90a4d48SPL ID 44ecbffa-e4aa-9dd3-e063-6394a90a4d48SPL set ID f55bcc41-2e8d-4ee5-9993-05c7d86f2d2cRxCUI 199519UNII 033KF7V46H
Pharmacologic class: Nitroimidazole Antimicrobial

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

N444523045012 followed by a unit qualifier and the quantity

Package 44523-0450-12. 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 Dec 1, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

1.1 Trichomoniasis Tinidazole is indicated for the treatment of trichomoniasis caused by Trichomonas vaginalis . The organism should be identified by appropriate diagnostic procedures. Because trichomoniasis is a sexually transmitted disease with potentially serious sequelae, partners of infected patients should be treated simultaneously in order to prevent re-infection [see Clinical Studies (14.1)]. 1.2 Giardiasis Tinidazole is indicated for the treatment of giardiasis caused by Giardia duodenalis (also termed G. lamblia) in both adults and pediatric patients older than three years of age [see Clinical Studies (14.2)]. 1.3 Amebiasis Tinidazole is indicated for the treatment of intestinal am…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 44523-450

What is NDC 44523-450?: 44523-450 is the product NDC for Tinidazole, Tinidazole 500 mg/1 tablet, film coated, listed with the FDA by BioComp Pharma, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Tinidazole.
What is the active ingredient?: Tinidazole.
Who is the labeler?: BioComp Pharma, Inc., NDC labeler code 44523. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Tinidazole?: 7 other product NDCs are listed under this name. See all Tinidazole 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 Tinidazole NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Tinidazole	Tinidazole 500 mg/1	TabletOral	REMEDYREPACK INC.	70518-4727	70518-4727-00
Tinidazole	Tinidazole 250 mg/1	TabletOral	Edenbridge Pharmaceuticals LLC.	42799-207	42799-0207-01
Tinidazole	Tinidazole 500 mg/1	TabletOral	Edenbridge Pharmaceuticals LLC.	42799-208	42799-0208-0142799-0208-02
Tinidazole	Tinidazole 250 mg/1	Tablet, Film coatedOral	Chartwell RX, LLC	62135-834	62135-0834-20
Tinidazole	Tinidazole 500 mg/1	Tablet, Film coatedOral	Chartwell RX, LLC	62135-835	62135-0835-20
Tinidazole	Tinidazole 250 mg/1	TabletOral	Lupin Pharmaceuticals,Inc.	43386-550	43386-0550-04
Tinidazole	Tinidazole 500 mg/1	TabletOral	Lupin Pharmaceuticals,Inc.	43386-551	43386-0551-0243386-0551-06

Other NDCs under NDA 021618

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 021618
Product	Strength	Form · route	Labeler	Product NDC
Tindamaxtinidazole	Tinidazole 250 mg/1	Tablet, Film coatedOral	Mission Pharmacal Company	0178-8250
Tindamaxtinidazole	Tinidazole 500 mg/1	Tablet, Film coatedOral	Mission Pharmacal Company	0178-8500