metronidazole vaginal
- Product NDC
- 71656-067
- 11-digit product format
- 716560067
- Labeler code
- 71656
- Product ID
- 71656-067_2bb2bd7b-190e-1821-e063-6294a90a5c0e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- metronidazole
- Dosage form
- GEL
- Route
- VAGINAL
- Labeler
- Saptalis Pharmaceuticals LLC
- Application
- ANDA216750
- Marketing category
- ANDA
- Marketing start
- 2025-03-03
- 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
- 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 |
|---|
| 71656-067-70 | metronidazole vaginal | 70 g in 1 TUBE, WITH APPLICATOR | GEL | 70 | | 1 |
| 71656-067-70 | metronidazole vaginal | 1 in 1 CARTON | GEL | 1 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71656-067 | METRONIDAZOLE VAGINAL (METRONIDAZOLE) GEL [SAPTALIS PHARMACEUTICALS LLC] | 1 | Current NDC, 2 package rows | 20250304_08abacec-3b6a-43e7-bfaa-2041d87a26c7.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71656-067-70 | 71656006770 | 1 TUBE, WITH APPLICATOR in 1 CARTON (71656-067-70) / 70 g in 1 TUBE, WITH APPLICATOR | 2025-03-03 | No | No | Current |