Metronidazole
- Product NDC
- 59651-770
- 11-digit product format
- 596510770
- Labeler code
- 59651
- Product ID
- 59651-770_0b6f6fbd-0292-4c48-a4ae-c24b5f0c8f74
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metronidazole
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA219295
- Marketing category
- ANDA
- Marketing start
- 2025-07-09
- 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 |
|---|---|
| METRONIDAZOLE | 7.5 mg/g |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 140QMO216E |
| Rxcui | 311678 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 8ffb9b1d-3ed7-ba2e-677e-47d4d134fd55 | Product name | 5 | 20251024 |
| 7f6d14e0-4366-41bc-a4a9-b74c79a20e17 | Product name | 1 | 20250623 |
| e6d321b0-0e5e-7da6-f043-92b6a91f00a1 | Product name | 5 | 20250515 |
| e1aac33b-94ae-4ee9-905b-299f7263853b | Product name | 3 | 20250124 |
| 16642716-d28a-4f90-8dcb-3921cd8c8109 | Product name | 4 | 20240516 |
| 0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15 | Product name | 1 | 20240313 |
| dea2eded-d1e7-46bb-9a3d-f8dc20de6277 | Product name | 1 | 20190408 |
| a5070875-62bb-61e1-fd46-8f7054197a40 | Product name | 8 | 20180215 |
| 0add4de9-d152-3375-3390-1123dddc5e3d | Product name | 1 | 20140508 |
| 33ca0fcc-1011-92dc-50a9-a383683eed1e | Product name | 1 | 20140508 |
| 53f39d9f-cd3f-04e1-c668-d4580719d57d | Product name | 1 | 20140508 |
| 9869efd7-d6dd-0665-5b67-53adbe6ef15e | Product name | 1 | 20140508 |
| a804000f-b74f-0b5d-d17b-aa767c286ddb | Product name | 1 | 20140508 |
| a91ea265-6e02-c08f-93c8-686d54180529 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 59651-770-46 | Metronidazole | 45 g in 1 TUBE | CREAM | 45 | 1 | |
| 59651-770-46 | Metronidazole | 1 in 1 CARTON | CREAM | 1 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 59651-770-46 | GM - Gram | 59651-770 | 03f66e10-049b-4f3e-aa2d-7a04024872fb | 1 | 2026-02-05 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 311678 | metroNIDAZOLE 0.75 % Topical Cream | PSN | 0b6f6fbd-0292-4c48-a4ae-c24b5f0c8f74 | 1 |
| 311678 | metronidazole 7.5 MG/ML Topical Cream | SCD | 0b6f6fbd-0292-4c48-a4ae-c24b5f0c8f74 | 1 |
| 311678 | metronidazole 0.75 % Topical Cream | SY | 0b6f6fbd-0292-4c48-a4ae-c24b5f0c8f74 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 59651-770-46 | 59651077046 | 1 TUBE in 1 CARTON (59651-770-46) / 45 g in 1 TUBE | 1 tube | 2025-07-09 | No | No | Current |