Metronidazole
- Product NDC
- 50436-4033
- 11-digit product format
- 504364033
- Labeler code
- 50436
- Product ID
- 50436-4033_a4f6fca2-035d-4406-bd2d-7e5bd67a75bc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metronidazole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Unit Dose Services
- Application
- ANDA070044
- Marketing category
- ANDA
- Marketing start
- 2011-08-22
- 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 |
|---|---|---|---|---|---|
| 50436-4033-0 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-42a9-f424-e053-dadaa90a57ce | METRONIDAZOLE TABLETS, USP 250 mg and 500 mg Revised: September 2015 Rx Only |
| 50436-4033-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-42a9-f424-e053-dadaa90a57ce | METRONIDAZOLE TABLETS, USP 250 mg and 500 mg Revised: September 2015 Rx Only |
| 50436-4033-5 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-42a9-f424-e053-dadaa90a57ce | METRONIDAZOLE TABLETS, USP 250 mg and 500 mg Revised: September 2015 Rx Only |
| 50436-4033-9 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-42a9-f424-e053-dadaa90a57ce | METRONIDAZOLE TABLETS, USP 250 mg and 500 mg Revised: September 2015 Rx Only |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50436-4033-0 | Metronidazole | 6 in 1 BOTTLE | TABLET | 6 | 8 | |
| 50436-4033-1 | Metronidazole | 14 in 1 BOTTLE | TABLET | 14 | 8 | |
| 50436-4033-5 | Metronidazole | 20 in 1 BOTTLE | TABLET | 20 | 8 | |
| 50436-4033-9 | Metronidazole | 10 in 1 BOTTLE | TABLET | 10 | 8 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| METRONIDAZOLE | ACTIVE INGREDIENT | 140QMO216E | METRONIDAZOLE TABLET [UNIT DOSE SERVICES] | 2 | |
| METRONIDAZOLE | ACTIVE MOIETY | 140QMO216E | METRONIDAZOLE TABLET [UNIT DOSE SERVICES] | 2 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | METRONIDAZOLE TABLET [UNIT DOSE SERVICES] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | METRONIDAZOLE TABLET [UNIT DOSE SERVICES] | 2 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | METRONIDAZOLE TABLET [UNIT DOSE SERVICES] | 2 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | METRONIDAZOLE TABLET [UNIT DOSE SERVICES] | 2 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | METRONIDAZOLE TABLET [UNIT DOSE SERVICES] | 2 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | METRONIDAZOLE TABLET [UNIT DOSE SERVICES] | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50436-4033 | METRONIDAZOLE TABLET [UNIT DOSE SERVICES] | 8 | Legacy NDC, 4 package rows | 20171128_566c68a0-50e6-4627-bb24-10ff4ce73181.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 311681 | metroNIDAZOLE 500 MG Oral Tablet | PSN | 566c68a0-50e6-4627-bb24-10ff4ce73181 | 8 |
| 311681 | metronidazole 500 MG Oral Tablet | SCD | 566c68a0-50e6-4627-bb24-10ff4ce73181 | 8 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 50436-4033-0 | 50436403300 | 6 in 1 BOTTLE | Historical |
| 50436-4033-1 | 50436403301 | 14 in 1 BOTTLE | Historical |
| 50436-4033-5 | 50436403305 | 20 in 1 BOTTLE | Historical |
| 50436-4033-9 | 50436403309 | 10 in 1 BOTTLE | Historical |