Metronidazole
- Product NDC
- 71709-130
- 11-digit product format
- 717090130
- Labeler code
- 71709
- Product ID
- 71709-130_714ea7b9-765b-d678-e053-2995a90ad254
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metronidazole
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Metcure Pharmaceuticals, Inc.
- Application
- ANDA070039
- Marketing category
- ANDA
- Marketing start
- 2018-07-18
- Marketing end
- 0000-00-00
- Substance
- METRONIDAZOLE
- Active strength
- 500 mg/1
- Pharmacologic classes
- Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [CS]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- 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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 71709-130-04 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-8f9e-f424-e053-dadaa90a57ce | Metronidazole |
| 71709-130-06 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-8f9e-f424-e053-dadaa90a57ce | Metronidazole |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 71709-130-04 | Metronidazole | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | 1 | |
| 71709-130-06 | Metronidazole | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 71709-130-04 | EA - Each | 71709-130 | bb2e3d9b-5f7d-4cb1-8296-268901459a40 | 1 | 2018-11-06 |
| 71709-130-06 | EA - Each | 71709-130 | 1867386a-067b-4a58-a08e-ed81b9eb6390 | 1 | 2018-11-06 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 314106 | metroNIDAZOLE 250 MG Oral Tablet | PSN | 714ea7b9-765a-d678-e053-2995a90ad254 | 1 |
| 311681 | metroNIDAZOLE 500 MG Oral Tablet | PSN | 714ea7b9-765a-d678-e053-2995a90ad254 | 1 |
| 314106 | metronidazole 250 MG Oral Tablet | SCD | 714ea7b9-765a-d678-e053-2995a90ad254 | 1 |
| 311681 | metronidazole 500 MG Oral Tablet | SCD | 714ea7b9-765a-d678-e053-2995a90ad254 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 71709-130-04 | 71709013004 | 100 in 1 BOTTLE | Historical |
| 71709-130-06 | 71709013006 | 500 in 1 BOTTLE | Historical |