METRONIDAZOLE
- Product NDC
- 21922-070
- 11-digit product format
- 219220070
- Labeler code
- 21922
- Product ID
- 21922-070_a0c70ee2-3ac6-4610-8592-642fd2d1aafc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metronidazole Topical
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Encube Ethicals, Inc.
- Application
- ANDA077547
- Marketing category
- ANDA
- Marketing start
- 2025-01-28
- 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 |
| Rxcui | 311679 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 21922-070-06 | METRONIDAZOLE | 45 g in 1 TUBE | GEL | 45 | | 2 |
| 21922-070-06 | METRONIDAZOLE | 1 in 1 CARTON | GEL | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 21922-070 | METRONIDAZOLE (METRONIDAZOLE TOPICAL) GEL [ENCUBE ETHICALS PRIVATE LIMITED] | 1 | Current NDC, 2 package rows | 20250207_05707735-e676-412a-9a77-ebd003afb16c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 21922-070-06 | 21922007006 | 1 TUBE in 1 CARTON (21922-070-06) / 45 g in 1 TUBE | 1 tube | 2025-01-28 | No | No | Current |