Metronidazole
- Product NDC
- 16714-557
- 11-digit product format
- 167140557
- Labeler code
- 16714
- Product ID
- 16714-557_d2cdc0ba-3387-4cee-8ba3-6e4b8cbb4e2e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metronidazole
- Dosage form
- GEL
- Route
- VAGINAL
- Labeler
- Northstar Rx LLC
- Application
- ANDA215794
- Marketing category
- ANDA
- Marketing start
- 2022-06-24
- Substance
- METRONIDAZOLE
- Active strength
- 7.5 mg/g
- 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 | 7.5 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 140QMO216E |
| Rxcui | 142046 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 16714-557-01 | Metronidazole | 1 in 1 CARTON | GEL | 1 | | 3 |
| 16714-557-01 | Metronidazole | 70 g in 1 TUBE, WITH APPLICATOR | GEL | 70 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16714-557 | METRONIDAZOLE GEL [NORTHSTAR RX LLC] | 2 | Current NDC, Legacy NDC, 2 package rows | 20240103_65cda174-d840-488a-96d0-74d6086b7048.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 16714-557-01 | 16714055701 | 1 TUBE, WITH APPLICATOR in 1 CARTON (16714-557-01) / 70 g in 1 TUBE, WITH APPLICATOR | 2022-06-24 | 0000-00-00 | No | No | Current |