Metronidazole
- Product NDC
- 51655-441
- 11-digit product format
- 516550441
- Labeler code
- 51655
- Product ID
- 51655-441_4b4409ed-781d-8784-e063-6294a90a580a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- METRONIDAZOLE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Northwind Health Company, LLC
- Application
- ANDA205245
- Marketing category
- ANDA
- Marketing start
- 2022-11-30
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51655-441-20 | Metronidazole | 20 in 1 BOTTLE, PLASTIC | TABLET | 20 | | 4 |
| 51655-441-21 | Metronidazole | 21 in 1 BOTTLE, PLASTIC | TABLET | 21 | | 4 |
| 51655-441-52 | Metronidazole | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 4 |
| 51655-441-84 | Metronidazole | 14 in 1 BOTTLE, PLASTIC | TABLET | 14 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51655-441 | METRONIDAZOLE TABLET [NORTHWIND PHARMACEUTICALS, LLC] | 3 | Current NDC, 4 package rows | 20240723_f2f55405-7f21-3ccc-e053-2a95a90a195a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 51655-441-20 | 51655044120 | 20 TABLET in 1 BOTTLE, PLASTIC (51655-441-20) | 20 tablet | 2023-01-19 | No | No | Current |
| 51655-441-21 | 51655044121 | 21 TABLET in 1 BOTTLE, PLASTIC (51655-441-21) | 21 tablet | 2022-11-30 | No | No | Current |
| 51655-441-52 | 51655044152 | 30 TABLET in 1 BOTTLE, PLASTIC (51655-441-52) | 30 tablet | 2023-06-27 | No | No | Current |
| 51655-441-84 | 51655044184 | 14 TABLET in 1 BOTTLE, PLASTIC (51655-441-84) | 14 tablet | 2023-01-11 | No | No | Current |