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 |