Metronidazole
- Product NDC
- 46708-630
- 11-digit product format
- 467080630
- Labeler code
- 46708
- Product ID
- 46708-630_ccb6c97f-34f9-4aeb-81ba-824a9b8a0ecd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metronidazole
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA212646
- Marketing category
- ANDA
- Marketing start
- 2025-03-17
- 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#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 46708-630 | METRONIDAZOLE GEL [ALEMBIC PHARMACEUTICALS LIMITED] | 1 | Current NDC, 6 package rows | 20250321_e43b880b-ce69-4f56-9c1c-9c7ca23bba84.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 |
|---|
| 46708-630-45 | 46708063045 | 1 TUBE in 1 CARTON (46708-630-45) / 45 g in 1 TUBE | 1 tube | 2025-03-17 | No | No | Current |
| 46708-630-55 | 46708063055 | 1 BOTTLE, PUMP in 1 CARTON (46708-630-55) / 55 g in 1 BOTTLE, PUMP | | 2025-03-17 | No | No | Current |
| 46708-630-60 | 46708063060 | 1 TUBE in 1 CARTON (46708-630-60) / 60 g in 1 TUBE | 1 tube | 2025-03-17 | No | No | Current |