Hydrocodone Bitartrate and Acetaminophen
- Product NDC
- 35356-797
- 11-digit product format
- 353560797
- Labeler code
- 35356
- Product ID
- 35356-797_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
- 8 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 |
|---|---|---|---|---|---|
| 35356-797-01 | EA - Each | 35356-797 | b84ec87a-59d3-4f3e-af0f-bd604c6541a0 | 1 | 2013-02-13 |
| 35356-797-08 | EA - Each | 35356-797 | a685a4dd-a012-419c-a3a4-f7e4521bb47b | 1 | 2014-01-04 |
| 35356-797-15 | EA - Each | 35356-797 | db4cad32-46d1-4657-b043-e477ea9b2ea3 | 1 | 2015-10-02 |
| 35356-797-30 | EA - Each | 35356-797 | b5bb4566-f06c-4843-8a52-d9a43c5b06f6 | 1 | 2013-02-13 |
| 35356-797-40 | EA - Each | 35356-797 | 2732d2fe-ad50-4a0d-a6c0-a7f4ff96320d | 1 | 2013-02-13 |
| 35356-797-60 | EA - Each | 35356-797 | 8f8c9e8e-9350-48a0-8bee-7ee50ad43be5 | 1 | 2013-02-13 |
| 35356-797-90 | EA - Each | 35356-797 | 9457c145-ed4e-4361-8f24-3b17f076207e | 1 | 2013-02-13 |