Metronidazole
- Product NDC
- 70771-1978
- 11-digit product format
- 707711978
- Labeler code
- 70771
- Product ID
- 70771-1978_a5ed3bb1-9a1b-45de-9e6f-01e374243b21
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metronidazole
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Zydus Lifesciences Limited
- Application
- ANDA220095
- Marketing category
- ANDA
- Marketing start
- 2026-02-14
- Substance
- METRONIDAZOLE
- Active strength
- 7.5 mg/g
- Pharmacologic classes
- Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Metronidazole
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| METRONIDAZOLE | 7.5 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 140QMO216E |
| Rxcui | 311679 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70771-1978-4 | Metronidazole | 45 g in 1 TUBE | GEL | 45 | | 1 |
| 70771-1978-4 | Metronidazole | 1 in 1 CARTON | GEL | 1 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70771-1978-4 | 70771197804 | 1 TUBE in 1 CARTON (70771-1978-4) / 45 g in 1 TUBE | 1 tube | 2026-02-14 | No | No | Current |