Metronidazole
- Product NDC
- 16571-665
- 11-digit product format
- 165710665
- Labeler code
- 16571
- Product ID
- 16571-665_241c7c4c-5fd9-4c0e-b7b7-4094f77e9721
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metronidazole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Rising Pharma Holdings, Inc.
- Application
- ANDA203974
- Marketing category
- ANDA
- Marketing start
- 2015-05-29
- Substance
- METRONIDAZOLE
- Active strength
- 250 mg/1
- 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 | 250 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 140QMO216E |
| Rxcui | 311681, 314106 |
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 |
| 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 |
|---|---|---|---|---|---|---|
| 16571-665-01 | Metronidazole | 100 in 1 BOTTLE | TABLET | 100 | 7 | |
| 16571-665-50 | Metronidazole | 500 in 1 BOTTLE | TABLET | 500 | 7 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 16571-665-01 | EA - Each | 16571-665 | 66e71a37-6766-462c-91cd-4e3481c8077f | 1 | 2020-06-05 |
| 16571-665-50 | EA - Each | 16571-665 | 45a3a143-ed32-432b-9b5f-5899dbddfdf7 | 1 | 2020-06-05 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 314106 | metroNIDAZOLE 250 MG Oral Tablet | PSN | 2fa14353-45df-429c-8759-7d66a65f08f0 | 105 |
| 314106 | metronidazole 250 MG Oral Tablet | SCD | 2fa14353-45df-429c-8759-7d66a65f08f0 | 105 |
| 314106 | metroNIDAZOLE 250 MG Oral Tablet | PSN | 93e4f174-4fe0-4cfd-a0cf-d0963e082107 | 7 |
| 311681 | metroNIDAZOLE 500 MG Oral Tablet | PSN | 93e4f174-4fe0-4cfd-a0cf-d0963e082107 | 7 |
| 314106 | metronidazole 250 MG Oral Tablet | SCD | 93e4f174-4fe0-4cfd-a0cf-d0963e082107 | 7 |
| 311681 | metronidazole 500 MG Oral Tablet | SCD | 93e4f174-4fe0-4cfd-a0cf-d0963e082107 | 7 |
| 314106 | metroNIDAZOLE 250 MG Oral Tablet | PSN | bff2f5bd-75a4-4252-a643-c21741ae8a96 | 4 |
| 314106 | metronidazole 250 MG Oral Tablet | SCD | bff2f5bd-75a4-4252-a643-c21741ae8a96 | 4 |
| 314106 | metroNIDAZOLE 250 MG Oral Tablet | PSN | e5850e05-7d71-3210-e053-2a95a90a0837 | 2 |
| 314106 | metroNIDAZOLE 250 MG Oral Tablet | PSN | e5bf5579-4f9c-f2b1-e053-2995a90ae497 | 2 |
| 314106 | metronidazole 250 MG Oral Tablet | SCD | e5850e05-7d71-3210-e053-2a95a90a0837 | 2 |
| 314106 | metronidazole 250 MG Oral Tablet | SCD | e5bf5579-4f9c-f2b1-e053-2995a90ae497 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 16571-665-01 | 16571066501 | 100 TABLET in 1 BOTTLE (16571-665-01) | 100 tablet | 2015-05-29 | 0000-00-00 | No | No | Current |
| 16571-665-50 | 16571066550 | 500 TABLET in 1 BOTTLE (16571-665-50) | 500 tablet | 2015-05-29 | 0000-00-00 | No | No | Current |