Metronidazole Vaginal Gel
- Product NDC
- 21922-046
- 11-digit product format
- 219220046
- Labeler code
- 21922
- Product ID
- 21922-046_fcf2dac3-2804-44d2-92ce-03c83220388c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metronidazole vaginal gel, 1.3 %
- Dosage form
- GEL
- Route
- VAGINAL
- Labeler
- Encube Ethicals, Inc.
- Application
- ANDA216795
- Marketing category
- ANDA
- Marketing start
- 2024-03-19
- Substance
- METRONIDAZOLE
- Active strength
- 65 mg/5g
- 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 Vaginal Gel
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| METRONIDAZOLE | 65 mg/5g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 140QMO216E |
| Rxcui | 1608253 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 21922-046-41 | Metronidazole Vaginal Gel | 5 g in 1 APPLICATOR | GEL | 5 | | 2 |
| 21922-046-41 | Metronidazole Vaginal Gel | 1 in 1 CARTON | GEL | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 21922-046 | METRONIDAZOLE VAGINAL GEL (METRONIDAZOLE VAGINAL GEL, 1.3 %) GEL [ENCUBE ETHICALS PRIVATE LIMITED] | 1 | Current NDC, 2 package rows | 20240321_585d2553-e19f-4227-82db-e4c2034863bf.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 |
|---|
| 21922-046-41 | 21922004641 | 1 APPLICATOR in 1 CARTON (21922-046-41) / 5 g in 1 APPLICATOR | 1 applicator | 2024-03-19 | No | No | Current |