Metronidazole
- Product NDC
- 15955-388
- 11-digit product format
- 159550388
- Labeler code
- 15955
- Product ID
- 15955-388_4bc960cb-872d-43da-81eb-0dbb058cfaad
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metronidazole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Alembic Labs LLC
- Application
- ANDA208681
- Marketing category
- ANDA
- Marketing start
- 2019-06-26
- Substance
- METRONIDAZOLE
- 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
- Metronidazole
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| METRONIDAZOLE | 250 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 140QMO216E |
| Rxcui | 311681, 314106 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 15955-388-01 | Metronidazole | 100 in 1 BOTTLE | TABLET | 100 | | 4 |
| 15955-388-05 | Metronidazole | 500 in 1 BOTTLE | TABLET | 500 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 15955-388 | METRONIDAZOLE TABLET [ALEMBIC LABS LLC] | 4 | Current NDC, Legacy NDC, 2 package rows | 20220706_86415209-5440-41da-abb8-e1a3d5051f91.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 |
|---|
| 15955-388-01 | 15955038801 | 100 TABLET in 1 BOTTLE (15955-388-01) | 100 tablet | 2019-06-26 | 0000-00-00 | No | No | Current |
| 15955-388-05 | 15955038805 | 500 TABLET in 1 BOTTLE (15955-388-05) | 500 tablet | 2019-06-26 | 0000-00-00 | No | No | Current |