Metronidazole
- Product NDC
- 0591-5215
- 11-digit product format
- 005915215
- Labeler code
- 0591
- Product ID
- 0591-5215_24f5f9ed-5a3d-4aae-83f1-473a890a5c3d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metronidazole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Actavis Pharma, Inc.
- Application
- ANDA070044
- Marketing category
- ANDA
- Marketing start
- 2014-11-24
- Marketing end
- 2019-12-31
- Substance
- METRONIDAZOLE
- Active strength
- 500 mg/1
- Pharmacologic classes
- Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [CS]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
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 Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0591-5215-05 | EA - Each | 0591-5215 | 03340e91-c0a0-4c31-84e5-d2ded14438d7 | 1 | 2015-01-05 |
| 0591-5215-50 | EA - Each | 0591-5215 | 9259b8b2-4e5f-4088-9e6f-4e715eab8f0f | 1 | 2015-01-05 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| METRONIDAZOLE | ACTIVE INGREDIENT | 140QMO216E | METRONIDAZOLE TABLET [BLENHEIM PHARMACAL, INC.] | 3 | |
| METRONIDAZOLE | ACTIVE MOIETY | 140QMO216E | METRONIDAZOLE TABLET [BLENHEIM PHARMACAL, INC.] | 3 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | METRONIDAZOLE TABLET [BLENHEIM PHARMACAL, INC.] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | METRONIDAZOLE TABLET [BLENHEIM PHARMACAL, INC.] | 3 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | METRONIDAZOLE TABLET [BLENHEIM PHARMACAL, INC.] | 3 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | METRONIDAZOLE TABLET [BLENHEIM PHARMACAL, INC.] | 3 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | METRONIDAZOLE TABLET [BLENHEIM PHARMACAL, INC.] | 3 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | METRONIDAZOLE TABLET [BLENHEIM PHARMACAL, INC.] | 3 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 311681 | metroNIDAZOLE 500 MG Oral Tablet | PSN | 1bdfb0e3-8397-6a61-e054-00144ff88e88 | 3 |
| 311681 | metronidazole 500 MG Oral Tablet | SCD | 1bdfb0e3-8397-6a61-e054-00144ff88e88 | 3 |
| 311681 | metroNIDAZOLE 500 MG Oral Tablet | PSN | 526b43ee-0245-1d9b-e054-00144ff8d46c | 1 |
| 311681 | metronidazole 500 MG Oral Tablet | SCD | 526b43ee-0245-1d9b-e054-00144ff8d46c | 1 |