Metronidazole
- Product NDC
- 68788-8552
- 11-digit product format
- 687888552
- Labeler code
- 68788
- Product ID
- 68788-8552_86325864-b6c8-460a-ae9d-3ad7463fd1db
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metronidazole
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA217128
- Marketing category
- ANDA
- Marketing start
- 2023-11-20
- 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 | 311678 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68788-8552-4 | Metronidazole | 1 in 1 CARTON | CREAM | 1 | | 2 |
| 68788-8552-4 | Metronidazole | 45 g in 1 TUBE | CREAM | 45 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-8552 | METRONIDAZOLE CREAM [PREFERRED PHARMACEUTICALS INC.] | 2 | Current NDC, 2 package rows | 20250117_59e53582-244a-4e9d-b18e-75dddc6a5052.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 |
|---|
| 68788-8552-4 | 68788855204 | 1 TUBE in 1 CARTON (68788-8552-4) / 45 g in 1 TUBE | 1 tube | 2023-11-20 | No | No | Historical |