Metronidazole
- Product NDC
- 53002-2478
- 11-digit product format
- 530022478
- Labeler code
- 53002
- Product ID
- 53002-2478_e12ed7c9-548d-440d-99df-b0df68f2e1b6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metronidazole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA070033
- Marketing category
- ANDA
- Marketing start
- 1990-09-30
- 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
- 2021-12-31
- 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 |
|---|---|---|---|---|---|
| 53002-2478-1 | 2025-01-30 | C162847 | 48780-1 | 9d75b9d0-434e-f424-e053-dadaa90a57ce | Metronidazole Tablets, USP |
| 53002-2478-1 | 2023-06-08 | C162847 | 48780-1 | 9d75b9d0-434e-f424-e053-dadaa90a57ce | Metronidazole Tablets, USP |
| 53002-2478-1 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d0-434e-f424-e053-dadaa90a57ce | Metronidazole Tablets, USP |
| 53002-2478-1 | 2020-12-16 | C162847 | 48780-1 | 9d75b9d0-434e-f424-e053-dadaa90a57ce | Metronidazole Tablets, USP |
| 53002-2478-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-434e-f424-e053-dadaa90a57ce | Metronidazole Tablets, USP |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53002-2478-1 | Metronidazole | 4 in 1 BOTTLE | TABLET | 4 | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 53002-2478 | METRONIDAZOLE TABLET [RPK PHARMACEUTICALS, INC.] | 5 | Legacy NDC, 1 package rows | 20230609_a59fd68d-a8ab-4004-b73c-0e9d6e887efd.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 311681 | metroNIDAZOLE 500 MG Oral Tablet | PSN | a59fd68d-a8ab-4004-b73c-0e9d6e887efd | 5 |
| 311681 | metronidazole 500 MG Oral Tablet | SCD | a59fd68d-a8ab-4004-b73c-0e9d6e887efd | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 53002-2478-1 | 53002247801 | 4 TABLET in 1 BOTTLE (53002-2478-1) | 4 tablet | 2017-10-01 | 0000-00-00 | No | No | Current |