Metronidazole
- Product NDC
- 0713-0574
- 11-digit product format
- 007130574
- Labeler code
- 0713
- Product ID
- 0713-0574_f38e0e45-e6e7-84f3-e053-2995a90a197c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- metronidazole
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Cosette Pharmaceuticals, Inc.
- Application
- ANDA216692
- Marketing category
- ANDA
- Marketing start
- 2023-02-01
- Substance
- METRONIDAZOLE
- Active strength
- 10 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 | 10 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 140QMO216E |
| Rxcui | 577237 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0713-0574-60 | Metronidazole | 60 g in 1 TUBE | GEL | 60 | | 1 |
| 0713-0574-60 | Metronidazole | 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 |
|---|
| 0713-0574 | METRONIDAZOLE GEL [COSETTE PHARMACEUTICALS, INC.] | 1 | Current NDC, 2 package rows | 20230201_a0d7d4e8-28c0-4211-8d76-73a173b48d9a.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 |
|---|
| 0713-0574-60 | 00713057460 | 1 TUBE in 1 CARTON (0713-0574-60) / 60 g in 1 TUBE | 1 tube | 2023-02-01 | No | No | Current |