Metronidazole
- Product NDC
- 0143-9772
- 11-digit product format
- 001439772
- Labeler code
- 0143
- Product ID
- 0143-9772_3f26593b-687f-47ba-8ad9-621d39c45b6b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metronidazole
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- West-ward Pharmaceutical Corp
- Application
- ANDA078084
- Marketing category
- ANDA
- Marketing start
- 2009-08-04
- Marketing end
- 0000-00-00
- Substance
- METRONIDAZOLE
- Active strength
- 500 mg/100mL
- Pharmacologic classes
- Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [CS]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 0143-9772 | I | Inactivated by FDA | 2026-07-31 | ||
| excluded package | package | 0143-9772 | 0143-9772-26 | I | Inactivated by FDA | 2026-07-31 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078084-001 | METRONIDAZOLE IN PLASTIC CONTAINER | METRONIDAZOLE | 500MG/100ML | INJECTABLE / INJECTION | 2008-03-31 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A078084-001 | METRONIDAZOLE IN PLASTIC CONTAINER | 500MG/100ML | INJECTABLE / INJECTION | 2008-03-31 | a50c72e98297… |
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 |
|---|---|---|---|---|---|
| 0143-9772-26 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-cd11-621f-e053-dbdaa90a74ad | Metronidazole Injection |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| METRONIDAZOLE | ACTIVE INGREDIENT | 140QMO216E | METRONIDAZOLE INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP] | 2 | |
| METRONIDAZOLE | ACTIVE MOIETY | 140QMO216E | METRONIDAZOLE INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP] | 2 | |
| ANHYDROUS CITRIC ACID | INACTIVE INGREDIENT | XF417D3PSL | METRONIDAZOLE INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP] | 2 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | METRONIDAZOLE INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP] | 2 | |
| SODIUM PHOSPHATE, DIBASIC | INACTIVE INGREDIENT | GR686LBA74 | METRONIDAZOLE INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP] | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | METRONIDAZOLE INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP] | 2 |