Hydrocodone Bitartrate and Acetaminophen
- Product NDC
- 35356-795
- 11-digit product format
- 353560795
- Labeler code
- 35356
- Product ID
- 35356-795_7ad923bd-4f60-4945-8420-b3f55e1aa798
- 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
- 10 mg/1; mg/1
- Pharmacologic classes
- Opioid Agonist [EPC],Opioid Agonists [MoA]
- 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 |
|---|---|---|---|---|---|
| 35356-795-01 | EA - Each | 35356-795 | f7ff36ff-6180-4527-a3f1-5d77410330f0 | 1 | 2013-07-02 |
| 35356-795-08 | EA - Each | 35356-795 | ebf95492-6dfb-4740-9a54-e5e3e7078ddb | 1 | 2013-12-02 |
| 35356-795-14 | EA - Each | 35356-795 | 4def2f9e-6858-427d-9132-2304d6ce5770 | 1 | 2017-06-15 |
| 35356-795-15 | EA - Each | 35356-795 | 638e1826-a1c8-489f-a245-0ea7c8688d04 | 1 | 2018-01-12 |
| 35356-795-21 | EA - Each | 35356-795 | f1387dac-0cd6-401a-8fad-bc6484b2dff3 | 1 | 2017-06-15 |
| 35356-795-30 | EA - Each | 35356-795 | b8575456-58d2-4830-ad32-7aaea773a2d2 | 1 | 2013-02-13 |
| 35356-795-40 | EA - Each | 35356-795 | dc365e34-c887-4ccf-89d0-a0d088765027 | 1 | 2015-04-03 |
| 35356-795-60 | EA - Each | 35356-795 | 99d8e786-11be-490f-881d-bdd2d6fedba7 | 1 | 2013-02-13 |
| 35356-795-90 | EA - Each | 35356-795 | 78345273-a514-4a5e-a08c-ae8a94b9ee9d | 1 | 2013-02-13 |