Metronidazole
- Product NDC
- 16571-664
- 11-digit product format
- 165710664
- Labeler code
- 16571
- Product ID
- 16571-664_241c7c4c-5fd9-4c0e-b7b7-4094f77e9721
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metronidazole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Rising Pharma Holdings, Inc.
- Application
- ANDA203974
- Marketing category
- ANDA
- Marketing start
- 2015-05-29
- Substance
- METRONIDAZOLE
- 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
- Metronidazole
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| METRONIDAZOLE | 500 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 140QMO216E |
| Rxcui | 311681, 314106 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 16571-664-01 | Metronidazole | 100 in 1 BOTTLE | TABLET | 100 | | 7 |
| 16571-664-50 | Metronidazole | 500 in 1 BOTTLE | TABLET | 500 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16571-664 | METRONIDAZOLE TABLET [RISING PHARMA HOLDINGS, INC.] | 7 | Current NDC, Legacy NDC, 2 package rows | 20241015_93e4f174-4fe0-4cfd-a0cf-d0963e082107.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 |
|---|
| 16571-664-01 | 16571066401 | 100 TABLET in 1 BOTTLE (16571-664-01) | 100 tablet | 2015-05-29 | 0000-00-00 | No | No | Current |
| 16571-664-50 | 16571066450 | 500 TABLET in 1 BOTTLE (16571-664-50) | 500 tablet | 2015-05-29 | 0000-00-00 | No | No | Current |