Tinidazole
- Product NDC
- 44523-450
- 11-digit product format
- 445230450
- Labeler code
- 44523
- Product ID
- 44523-450_44ecbffa-e4aa-9dd3-e063-6394a90a4d48
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tinidazole
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- BioComp Pharma, Inc.
- Application
- NDA021618
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2025-03-20
- Substance
- TINIDAZOLE
- Active strength
- 500 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 | 500 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 033KF7V46H |
| Rxcui | 199519 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 44523-450-12 | Tinidazole | 12 in 1 BOTTLE | TABLET, FILM COATED | 12 | | 5 |
| 44523-450-20 | Tinidazole | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | | 5 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Tinidazole | ACTIVE INGREDIENT | 033KF7V46H | TINIDAZOLE TABLET [BIOCOMP PHARMA, INC.] | 1 | |
| Tinidazole | ACTIVE MOIETY | 033KF7V46H | TINIDAZOLE TABLET [BIOCOMP PHARMA, INC.] | 1 | |
| Aluminum Oxide | INACTIVE INGREDIENT | LMI26O6933 | TINIDAZOLE TABLET [BIOCOMP PHARMA, INC.] | 1 | |
| Cellulose, Microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | TINIDAZOLE TABLET [BIOCOMP PHARMA, INC.] | 1 | |
| Croscarmellose Sodium | INACTIVE INGREDIENT | M28OL1HH48 | TINIDAZOLE TABLET [BIOCOMP PHARMA, INC.] | 1 | |
| FD&C Red No. 40 | INACTIVE INGREDIENT | WZB9127XOA | TINIDAZOLE TABLET [BIOCOMP PHARMA, INC.] | 1 | |
| FD&C Yellow No. 6 | INACTIVE INGREDIENT | H77VEI93A8 | TINIDAZOLE TABLET [BIOCOMP PHARMA, INC.] | 1 | |
| Hypromelloses | INACTIVE INGREDIENT | 3NXW29V3WO | TINIDAZOLE TABLET [BIOCOMP PHARMA, INC.] | 1 | |
| Magnesium Stearate | INACTIVE INGREDIENT | 70097M6I30 | TINIDAZOLE TABLET [BIOCOMP PHARMA, INC.] | 1 | |
| Polydextrose | INACTIVE INGREDIENT | VH2XOU12IE | TINIDAZOLE TABLET [BIOCOMP PHARMA, INC.] | 1 | |
| Polyethylene Glycols | INACTIVE INGREDIENT | 3WJQ0SDW1A | TINIDAZOLE TABLET [BIOCOMP PHARMA, INC.] | 1 | |
| Starch, Corn | INACTIVE INGREDIENT | O8232NY3SJ | TINIDAZOLE TABLET [BIOCOMP PHARMA, INC.] | 1 | |
| Titanium Dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | TINIDAZOLE TABLET [BIOCOMP PHARMA, INC.] | 1 | |
| Triacetin | INACTIVE INGREDIENT | XHX3C3X673 | TINIDAZOLE TABLET [BIOCOMP PHARMA, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 44523-450 | TINIDAZOLE TABLET, FILM COATED [BIO COMP PHARMA, INC.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20250327_f55bcc41-2e8d-4ee5-9993-05c7d86f2d2c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 44523-450-12 | 44523045012 | 12 TABLET, FILM COATED in 1 BOTTLE (44523-450-12) | 2025-03-20 | No | No | Historical |
| 44523-450-20 | 44523045020 | 20 TABLET, FILM COATED in 1 BOTTLE (44523-450-20) | 2025-03-20 | No | No | Historical |