HYRDROCODONE APAP is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Direct Rx. The primary component is Hydrocodone Bitartrate; Acetaminophen.
| Product ID | 61919-208_35e360f7-dc02-5dd9-e054-00144ff88e88 |
| NDC | 61919-208 |
| Product Type | Human Prescription Drug |
| Proprietary Name | HYRDROCODONE APAP |
| Generic Name | Hyrdrocodone Apap |
| Dosage Form | Tablet |
| Route of Administration | ORAL |
| Marketing Start Date | 2015-01-01 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA201013 |
| Labeler Name | Direct Rx |
| Substance Name | HYDROCODONE BITARTRATE; ACETAMINOPHEN |
| Active Ingredient Strength | 8 mg/1; mg/1 |
| Pharm Classes | Opioid Agonist [EPC],Opioid Agonists [MoA] |
| NDC Exclude Flag | E |
| Listing Certified Through | 2017-12-31 |
| Marketing Start Date | 2019-07-22 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA201013 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2019-06-12 |
| Marketing Category | ANDA |
| Application Number | ANDA201013 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2019-07-22 |
| Marketing Category | ANDA |
| Application Number | ANDA201013 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2015-01-01 |
| Inactivation Date | 2020-01-31 |
| Marketing Category | ANDA |
| Application Number | ANDA201013 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2015-01-01 |
| Inactivation Date | 2020-01-31 |
| Marketing Category | ANDA |
| Application Number | ANDA201013 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2019-07-22 |
| Ingredient | Strength |
|---|---|
| HYDROCODONE BITARTRATE | 7.5 mg/1 |
| SPL SET ID: | 36710b35-419c-4e64-8bd1-29b81a4c8e03 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |