Metronidazole Vaginal Gel, 0.75%
- Product NDC
- 21922-039
- 11-digit product format
- 219220039
- Labeler code
- 21922
- Product ID
- 21922-039_15d347d5-e345-4750-9f5e-6c2b4f9c583a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metronidazole
- Dosage form
- GEL
- Route
- VAGINAL
- Labeler
- Encube Ethicals, Inc.
- Application
- ANDA215610
- Marketing category
- ANDA
- Marketing start
- 2023-06-17
- Substance
- METRONIDAZOLE
- Active strength
- 7.5 mg/g
- 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, 0.75%
- Listing expiration
- 2026-12-31
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 |
|---|
| 21922-039-23 | Metronidazole Vaginal Gel, 0.75% | 1 in 1 CARTON | GEL | 1 | | 3 |
| 21922-039-23 | Metronidazole Vaginal Gel, 0.75% | 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 |
|---|
| 21922-039 | METRONIDAZOLE VAGINAL GEL, 0.75% (METRONIDAZOLE) GEL [ENCUBE ETHICALS PRIVATE LIMITED] | 2 | Current NDC, 2 package rows | 20250101_63ed1e7e-d264-4e35-af83-ec37fa5b06d1.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 21922-039-23 | 21922003923 | 1 TUBE, WITH APPLICATOR in 1 CARTON (21922-039-23) / 70 g in 1 TUBE, WITH APPLICATOR | 2023-06-17 | No | No | Current |