metronidazole
- Product NDC
- 58657-934
- 11-digit product format
- 586570934
- Labeler code
- 58657
- Product ID
- 58657-934_51018185-a67f-bf2c-e063-6394a90adca5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- metronidazole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Method Pharmaceuticals LLC
- Application
- ANDA070772
- Marketing category
- ANDA
- Marketing start
- 2025-07-01
- Substance
- METRONIDAZOLE
- Active strength
- 500 mg/1
- Pharmacologic classes
- Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- metronidazole
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| METRONIDAZOLE | 500 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 140QMO216E |
| Rxcui | 311681, 314106, 2702348 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 58657-934-01 | metronidazole | 100 in 1 CARTON | TABLET | 100 | | 4 |
| 58657-934-05 | metronidazole | 50 in 1 CARTON | TABLET | 50 | | 4 |
| 58657-934-10 | metronidazole | 1 in 1 BLISTER PACK | TABLET | 1 | | 4 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 58657-934-01 | 58657093401 | 100 BLISTER PACK in 1 CARTON (58657-934-01) / 1 TABLET in 1 BLISTER PACK (58657-934-10) | 100 blister pack | 2025-07-01 | No | No | Current |
| 58657-934-05 | 58657093405 | 50 BLISTER PACK in 1 CARTON (58657-934-05) / 1 TABLET in 1 BLISTER PACK (58657-934-10) | 50 blister pack | 2025-07-01 | No | No | Current |
| 58657-934-10 | 58657093410 | 1 in 1 BLISTER PACK | | | | | Historical |