Tindamax (tinidazole) NDC 0178-8500

NDC codes

FDA NDC Directory

Product NDC (as listed)0178-8500Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00178-8500Add 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
0178-8500-20	00178850020	20 TABLET, FILM COATED in 1 BOTTLE (0178-8500-20)Marketed from May 17, 2004
0178-8500-60	00178850060	60 TABLET, FILM COATED in 1 BOTTLE (0178-8500-60)Marketed from May 17, 2004

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): Tindamax
Generic name (nonproprietary): tinidazole
Active ingredients: Tinidazole — 500 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Mission Pharmacal Company
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 021618
Marketing start: May 17, 2004
Listing expires: Dec 31, 2026
Other FDA classes: Nitroimidazoles (Chemical structure)
Identifiers: Product ID 0178-8500_d423971d-34c8-c7d2-e053-2a95a90abe74SPL ID d423971d-34c8-c7d2-e053-2a95a90abe74SPL set ID a0d01539-8413-4703-94cc-d221918630a1RxCUI 199519, 477234, 539809, 539811UNII 033KF7V46HUPC 0301788250404, 0301788500202
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

N400178850020 followed by a unit qualifier and the quantity

Package 00178-8500-20. 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 27, 2021. This label includes a boxed warning.

Indications (excerpt from the label)

1 INDICATIONS AND USAGE 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 tre…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

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
Tinidazole	Tinidazole 500 mg/1	Tablet, Film coatedOral	BioComp Pharma, Inc.	44523-450
Tindamaxtinidazole	Tinidazole 250 mg/1	Tablet, Film coatedOral	Mission Pharmacal Company	0178-8250