Tinidazole
- Product NDC
- 43386-550
- 11-digit product format
- 433860550
- Labeler code
- 43386
- Product ID
- 43386-550_98a66e10-fb32-46ce-a68b-c21d615f6621
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tinidazole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Lupin Pharmaceuticals,Inc.
- Application
- ANDA202044
- Marketing category
- ANDA
- Marketing start
- 2012-04-30
- Substance
- TINIDAZOLE
- Active strength
- 250 mg/1
- Pharmacologic classes
- Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Tinidazole
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TINIDAZOLE | 250 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 033KF7V46H |
| Rxcui | 199519, 477234 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43386-550-04 | Tinidazole | 40 in 1 BOTTLE | TABLET | 40 | | 4 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| TINIDAZOLE | ACTIVE INGREDIENT | 033KF7V46H | TINIDAZOLE TABLET [GAVIS PHARMACEUTICALS, LLC] | 1 | |
| TINIDAZOLE | ACTIVE MOIETY | 033KF7V46H | TINIDAZOLE TABLET [GAVIS PHARMACEUTICALS, LLC] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | TINIDAZOLE TABLET [GAVIS PHARMACEUTICALS, LLC] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | TINIDAZOLE TABLET [GAVIS PHARMACEUTICALS, LLC] | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | TINIDAZOLE TABLET [GAVIS PHARMACEUTICALS, LLC] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | TINIDAZOLE TABLET [GAVIS PHARMACEUTICALS, LLC] | 1 | |
| POLYETHYLENE GLYCOL 3000 | INACTIVE INGREDIENT | SA1B764746 | TINIDAZOLE TABLET [GAVIS PHARMACEUTICALS, LLC] | 1 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | TINIDAZOLE TABLET [GAVIS PHARMACEUTICALS, LLC] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | TINIDAZOLE TABLET [GAVIS PHARMACEUTICALS, LLC] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | TINIDAZOLE TABLET [GAVIS PHARMACEUTICALS, LLC] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | TINIDAZOLE TABLET [GAVIS PHARMACEUTICALS, LLC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43386-550 | TINIDAZOLE TABLET [LUPIN PHARMACEUTICALS,INC.] | 4 | Current NDC, Legacy NDC, 1 package rows | 20230623_95ab57b2-5d7e-4986-abcd-65edf1728383.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43386-550-04 | 43386055004 | 40 TABLET in 1 BOTTLE (43386-550-04) | 40 tablet | 2012-04-30 | 0000-00-00 | No | No | Current |