Metronidazole
- Product NDC
- 46708-435
- 11-digit product format
- 467080435
- Labeler code
- 46708
- Product ID
- 46708-435_73035cba-781b-4d60-80bb-8f8ff273a0a1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- metronidazole
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA079065
- Marketing category
- ANDA
- Marketing start
- 2016-12-09
- Substance
- METRONIDAZOLE
- Active strength
- 375 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 | 375 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 140QMO216E |
| Rxcui | 199055 |
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 |
|---|
| 46708-435-30 | Metronidazole | 30 in 1 BOTTLE | CAPSULE | 30 | | 3 |
| 46708-435-31 | Metronidazole | 100 in 1 BOTTLE | CAPSULE | 100 | | 3 |
| 46708-435-50 | Metronidazole | 50 in 1 BOTTLE | CAPSULE | 50 | | 3 |
| 46708-435-71 | Metronidazole | 500 in 1 BOTTLE | CAPSULE | 500 | | 3 |
| 46708-435-91 | Metronidazole | 1000 in 1 BOTTLE | CAPSULE | 1000 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 46708-435 | METRONIDAZOLE CAPSULE [ALEMBIC PHARMACEUTICALS LIMITED] | 3 | Current NDC, Legacy NDC, 5 package rows | 20230202_387053e5-7eda-4282-b58a-5789430a2e99.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 |
|---|
| 46708-435-30 | 46708043530 | 30 CAPSULE in 1 BOTTLE (46708-435-30) | 30 capsule | 2016-12-09 | 0000-00-00 | No | No | Current |
| 46708-435-31 | 46708043531 | 100 CAPSULE in 1 BOTTLE (46708-435-31) | 100 capsule | 2016-12-09 | 0000-00-00 | No | No | Current |
| 46708-435-50 | 46708043550 | 50 CAPSULE in 1 BOTTLE (46708-435-50) | 50 capsule | 2016-12-09 | 0000-00-00 | No | No | Current |
| 46708-435-71 | 46708043571 | 500 CAPSULE in 1 BOTTLE (46708-435-71) | 500 capsule | 2016-12-09 | 0000-00-00 | No | No | Current |
| 46708-435-91 | 46708043591 | 1000 CAPSULE in 1 BOTTLE (46708-435-91) | 1000 capsule | 2016-12-09 | 0000-00-00 | No | No | Current |