metronidazole
- Product NDC
- 72578-008
- 11-digit product format
- 725780008
- Labeler code
- 72578
- Product ID
- 72578-008_855f53ac-75a4-48d0-9845-1de91708154d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- metronidazole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Viona Pharmaceuticals Inc
- Application
- ANDA206560
- Marketing category
- ANDA
- Marketing start
- 2019-02-23
- 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 |
|---|
| 72578-008-01 | metronidazole | 100 in 1 BOTTLE | TABLET | 100 | | 8 |
| 72578-008-05 | metronidazole | 500 in 1 BOTTLE | TABLET | 500 | | 8 |
| 72578-008-18 | metronidazole | 50 in 1 BOTTLE | TABLET | 50 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72578-008 | METRONIDAZOLE TABLET [VIONA PHARMACEUTICALS INC] | 8 | Current NDC, Legacy NDC, 3 package rows | 20240815_0f108035-d2ab-49c1-9f8d-daae11f0efe0.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 |
|---|
| 72578-008-01 | 72578000801 | 100 TABLET in 1 BOTTLE (72578-008-01) | 100 tablet | 2019-02-23 | 0000-00-00 | No | No | Current |
| 72578-008-05 | 72578000805 | 500 TABLET in 1 BOTTLE (72578-008-05) | 500 tablet | 2019-02-23 | 0000-00-00 | No | No | Current |
| 72578-008-18 | 72578000818 | 50 TABLET in 1 BOTTLE (72578-008-18) | 50 tablet | 2019-02-23 | 0000-00-00 | No | No | Current |