metronidazole vaginal
- Product NDC
- 45802-139
- 11-digit product format
- 458020139
- Labeler code
- 45802
- Product ID
- 45802-139_ac51fedf-e650-40c6-a92f-d33d6f32e54b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- metronidazole
- Dosage form
- GEL
- Route
- VAGINAL
- Labeler
- Padagis Israel Pharmaceuticals Ltd
- Application
- ANDA211786
- Marketing category
- ANDA
- Marketing start
- 2019-07-08
- 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 |
|---|
| 45802-139-70 | metronidazole vaginal | 70 g in 1 TUBE | GEL | 70 | | 3 |
| 45802-139-70 | metronidazole vaginal | 1 in 1 CARTON | GEL | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 45802-139 | METRONIDAZOLE VAGINAL (METRONIDAZOLE) GEL [PADAGIS ISRAEL PHARMACEUTICALS LTD] | 3 | Current NDC, Legacy NDC, 2 package rows | 20230728_eb240e7b-cec8-497b-8a49-7ed768e2b431.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 45802-139-70 | 45802013970 | 1 TUBE in 1 CARTON (45802-139-70) / 70 g in 1 TUBE | 1 tube | 2019-07-08 | 0000-00-00 | No | No | Current |