fomepizole
- Product NDC
- 0781-3182
- 11-digit product format
- 007813182
- Labeler code
- 0781
- Product ID
- 0781-3182_a306cd11-9acf-45f1-91ec-9fef2b08fdb1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- fomepizole
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Sandoz Inc.
- Application
- ANDA078537
- Marketing category
- ANDA
- Marketing start
- 2008-03-06
- Marketing end
- 0000-00-00
- Substance
- FOMEPIZOLE
- Active strength
- 1 g/mL
- Pharmacologic classes
- Antidote [EPC]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
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 | a306cd11-9acf-45f1-91ec-9fef2b08fdb1 |
| 0781-3182-84 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-c765-621f-e053-dbdaa90a74ad | a306cd11-9acf-45f1-91ec-9fef2b08fdb1 |
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 |