NDC 0781-3182-73 - fomepizole
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 0781-3182
- Requested NDC
- 0781-3182-73
- Package NDCs from labels
- 0781-3182-73, 0781-3182-84
- Manufacturer
- Sandoz Inc. | Emcure Pharmaceuticals Ltd.
- Effective date
- 2010-06-28
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| fomepizole - Sandoz Inc. | Emcure Pharmaceuticals Ltd. | Sandoz Inc. | Emcure Pharmaceuticals Ltd. | 2010-06-28 | Human Prescription Drug Label |
| National Council for Prescription Drug Programs indexing - billing unit | National Council for Prescription Drug Programs | 2012-07-24 | Indexing - Billing Unit |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0781-3182-84 | 2022-04-15 | C162847 | 48780-1 | 956f9ecf-c765-621f-e053-dbdaa90a74ad | Rx only Sterile Caution: Must be diluted prior to use. |
| 0781-3182-84 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-c765-621f-e053-dbdaa90a74ad | Rx only Sterile Caution: Must be diluted prior to use. |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0781-3182-73 | ML - Milliliter | 0781-3182 | ef96bc31-5dd2-4581-b887-a8837423754f | 1 | 2012-07-24 |
| 0781-3182-84 | ML - Milliliter | 0781-3182 | 53dc1331-01f1-45e0-bdec-95794f605cd3 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| FOMEPIZOLE | ACTIVE INGREDIENT | 83LCM6L2BY | FOMEPIZOLE INJECTION, SOLUTION [SANDOZ INC. ] | 1 | |
| FOMEPIZOLE | ACTIVE MOIETY | 83LCM6L2BY | FOMEPIZOLE INJECTION, SOLUTION [SANDOZ INC. ] | 1 |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Fomepizole | FOMEPIZOLE | Zydus Pharmaceuticals USA Inc. | 256910fe-91f2-48f6-b0b4-55edc52dacd4 | 2025-11-20 | Adverse reactions | ANDA078537 83LCM6L2BY |
| Fomepizole | FOMEPIZOLE | Navinta LLC | 6fed6052-f159-46d6-8be1-31e18a7ba918 | 2024-12-19 | Adverse reactions | ANDA078537 83LCM6L2BY |
| Fomepizole | FOMEPIZOLE | Sagent Pharmaceuticals | 1dea37fd-ec17-416e-b28e-980a87d49e1a | 2023-10-26 | Adverse reactions | 83LCM6L2BY |
| Fomepizole | FOMEPIZOLE | Gland Pharma Limited | 7e133194-dacb-446a-a657-2d2430a02373 | 2023-07-07 | Adverse reactions | 83LCM6L2BY |
| Fomepizole | FOMEPIZOLE | Mylan Institutional LLC | 911312e2-3a7c-4c97-88a8-b8d92cd12923 | 2021-04-15 | Adverse reactions | 83LCM6L2BY |
| fomepizole | FOMEPIZOLE | American Regent, Inc. | a31d0148-2729-49de-b666-f24b0dfd2401 | 2020-02-11 | Adverse reactions | 83LCM6L2BY |
| fomepizole | FOMEPIZOLE | American Regent, Inc. | 82dc2920-af7f-4e43-9f6d-8877a71884cd | 2019-12-06 | Adverse reactions | 83LCM6L2BY |
| 3fe22a3c-2384-4998-93ac-49a292ec166d | a306cd11-9acf-45f1-91ec-9fef2b08fdb1 | 2010-06-28 | Adverse reactions | a306cd11-9acf-45f1-91ec-9fef2b08fdb1 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.