Oxycodone and Acetaminophen
- Product NDC
- 35356-817
- 11-digit product format
- 353560817
- Labeler code
- 35356
- Product ID
- 35356-817_5edd966d-633c-4db6-aecc-f2f5d8f519df
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxycodone and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Lake Erie Medical DBA Quality Care Products LLC
- Application
- ANDA040777
- Marketing category
- ANDA
- Marketing start
- 2007-11-27
- Marketing end
- 0000-00-00
- Substance
- OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN
- Active strength
- 5 mg/1; mg/1
- Pharmacologic classes
- Full Opioid Agonists [MoA],Opioid Agonist [EPC]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 35356-817-01 | EA - Each | 35356-817 | 43785fcd-0d5f-4174-a00c-24b6d16a337b | 1 | 2013-02-19 |
| 35356-817-15 | EA - Each | 35356-817 | cf880847-013f-4651-8258-2457f3d1eaa7 | 1 | 2016-04-04 |
| 35356-817-20 | EA - Each | 35356-817 | e11913e5-ea32-4b8a-8438-25c2994e33db | 1 | 2013-02-19 |
| 35356-817-30 | EA - Each | 35356-817 | ce18f44b-61f1-4ce4-b36b-251bb00d638e | 1 | 2013-02-19 |
| 35356-817-40 | EA - Each | 35356-817 | a0cbe076-7f42-4369-922c-2ade3bd09393 | 1 | 2013-02-19 |
| 35356-817-60 | EA - Each | 35356-817 | 6ffe22e8-5292-4ce8-b522-393447cb2aa0 | 1 | 2013-02-19 |
| 35356-817-90 | EA - Each | 35356-817 | 71e17dc8-2bd2-4521-8fef-cf5e0dc91a3b | 1 | 2013-02-19 |