Hydrocodone Bitartrate and Acetaminophen
- Product NDC
- 35356-796
- 11-digit product format
- 353560796
- Labeler code
- 35356
- Product ID
- 35356-796_007b5379-4c11-417b-ab14-77b39a6435ad
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocodone Bitartrate and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Lake Erie Medical DBA Quality Care Products LLC
- Application
- ANDA201013
- Marketing category
- ANDA
- Marketing start
- 2012-04-12
- Marketing end
- 0000-00-00
- Substance
- HYDROCODONE BITARTRATE; ACETAMINOPHEN
- Active strength
- 5 mg/1; mg/1
- Pharmacologic classes
- Opioid Agonist [EPC],Opioid Agonists [MoA]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 35356-796-01 | EA - Each | 35356-796 | 2accacce-69a1-4702-a49f-2195ff6e8165 | 1 | 2013-02-13 |
| 35356-796-06 | EA - Each | 35356-796 | 85b16ca8-762a-4eb9-ad2a-3b426f36cbcb | 1 | 2015-10-02 |
| 35356-796-08 | EA - Each | 35356-796 | 35d5abb7-0805-4edf-865e-5f4147068299 | 1 | 2014-01-04 |
| 35356-796-20 | EA - Each | 35356-796 | 48d4b363-9205-48ab-81e3-58cf2cc9b833 | 1 | 2013-07-02 |
| 35356-796-30 | EA - Each | 35356-796 | 9007bbb3-9e1f-4a1c-aedd-3759578ec436 | 1 | 2013-02-13 |
| 35356-796-40 | EA - Each | 35356-796 | a45b75c8-94fd-4593-81a9-32a6e7314ce8 | 1 | 2013-02-13 |
| 35356-796-50 | EA - Each | 35356-796 | b8702e14-0026-48c8-8473-ef315134e0dc | 1 | 2013-02-13 |
| 35356-796-60 | EA - Each | 35356-796 | d0dec352-21b7-425a-b99c-f985a3de77f0 | 1 | 2013-02-13 |
| 35356-796-90 | EA - Each | 35356-796 | 279480b2-97a7-49be-b986-97cdbbafac9e | 1 | 2013-02-13 |