Metronidazole
- Product NDC
- 50090-7160
- 11-digit product format
- 500907160
- Labeler code
- 50090
- Product ID
- 50090-7160_54ce71c2-b878-455c-83b0-70525d10695a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metronidazole
- Dosage form
- GEL
- Route
- VAGINAL
- Labeler
- A-S Medication Solutions
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Metronidazole
- 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 |
DailyMed Product Concepts#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 50090-7160-0 | 50090716000 | 1 TUBE, WITH APPLICATOR in 1 CARTON (50090-7160-0) / 70 g in 1 TUBE, WITH APPLICATOR | 2024-05-02 | No | No | Current |