Prescription drug · NDA
Tindamax (Tinidazole) NDC 0178-8500
Tinidazole 500 mg/1 · Tablet, Film coated · Oral · Mission Pharmacal Company
NDC codes
FDA NDC Directory| 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 CompanyNDC labeler code 0178
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021618
- Marketing start
- Listing expires
- 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
N400178850020followed by a unit qualifier and the quantityPackage 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 . 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.
About NDC 0178-8500
- What is NDC 0178-8500?
- 0178-8500 is the product NDC for Tindamax (tinidazole), Tinidazole 500 mg/1 tablet, film coated, listed with the FDA by Mission Pharmacal Company. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tindamax (Tinidazole).
- What is the active ingredient?
- Tinidazole.
- Who is the labeler?
- Mission Pharmacal Company, NDC labeler code 0178. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Tindamax?
- 1 other product NDC are listed under this name. See all Tindamax NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Tindamax products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Tindamaxtinidazole | Tinidazole 250 mg/1 | Tablet, Film coatedOral | Mission Pharmacal Company | 0178-8250 | 00178-8250-40 |
Other NDCs under NDA 021618
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Tindamaxtinidazole | Tinidazole 250 mg/1 | Tablet, Film coatedOral | Mission Pharmacal Company | 0178-8250 |
| Tinidazole | Tinidazole 500 mg/1 | Tablet, Film coatedOral | BioComp Pharma, Inc. | 44523-450 |