Metronidazole
- Product NDC
- 46708-428
- 11-digit product format
- 467080428
- Labeler code
- 46708
- Product ID
- 46708-428_68765ffa-e238-40bb-8235-4ae53fb292e9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metronidazole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA079067
- Marketing category
- ANDA
- Marketing start
- 2016-12-01
- 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#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 46708-428-30 | Metronidazole | 30 in 1 BOTTLE | TABLET | 30 | | 3 |
| 46708-428-31 | Metronidazole | 100 in 1 BOTTLE | TABLET | 100 | | 3 |
| 46708-428-50 | Metronidazole | 50 in 1 BOTTLE | TABLET | 50 | | 3 |
| 46708-428-61 | Metronidazole | 250 in 1 BOTTLE | TABLET | 250 | | 3 |
| 46708-428-71 | Metronidazole | 500 in 1 BOTTLE | TABLET | 500 | | 3 |
| 46708-428-91 | Metronidazole | 1000 in 1 BOTTLE | TABLET | 1000 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 46708-428 | METRONIDAZOLE TABLET [ALEMBIC PHARMACEUTICALS LIMITED] | 3 | Current NDC, Legacy NDC, 6 package rows | 20230202_d7455566-16aa-488a-af2a-93b55a04c02f.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 |
|---|
| 46708-428-30 | 46708042830 | 30 TABLET in 1 BOTTLE (46708-428-30) | 30 tablet | 2016-12-01 | 0000-00-00 | No | No | Current |
| 46708-428-31 | 46708042831 | 100 TABLET in 1 BOTTLE (46708-428-31) | 100 tablet | 2016-12-01 | 0000-00-00 | No | No | Current |
| 46708-428-50 | 46708042850 | 50 TABLET in 1 BOTTLE (46708-428-50) | 50 tablet | 2016-12-01 | 0000-00-00 | No | No | Current |
| 46708-428-61 | 46708042861 | 250 TABLET in 1 BOTTLE (46708-428-61) | 250 tablet | 2016-12-01 | 0000-00-00 | No | No | Current |
| 46708-428-71 | 46708042871 | 500 TABLET in 1 BOTTLE (46708-428-71) | 500 tablet | 2016-12-01 | 0000-00-00 | No | No | Current |
| 46708-428-91 | 46708042891 | 1000 TABLET in 1 BOTTLE (46708-428-91) | 1000 tablet | 2016-12-01 | 0000-00-00 | No | No | Current |