Tinidazole
- Product NDC
- 62135-835
- 11-digit product format
- 621350835
- Labeler code
- 62135
- Product ID
- 62135-835_1d71c803-2d38-ccc8-e063-6294a90a7923
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tinidazole
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Chartwell RX, LLC
- Application
- ANDA202044
- Marketing category
- ANDA
- Marketing start
- 2012-04-30
- 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, 477234 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 62135-835-20 | Tinidazole | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62135-835 | TINIDAZOLE TABLET, FILM COATED [CHARTWELL RX, LLC] | 1 | Current NDC, 1 package rows | 20240719_b39bc167-f1c4-4169-8b46-e6c2eafe6bbf.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 62135-835-20 | 62135083520 | 20 TABLET, FILM COATED in 1 BOTTLE (62135-835-20) | 2024-07-05 | No | No | Historical |