Hydrocodone Bitartate and Acetaminophen - HYDROCODONE BITARTRATE, ACETAMINOPHEN
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Field |
Value |
NDC Code: |
35356-766 |
Proprietary Name: |
Hydrocodone Bitartate and Acetaminophen |
Suffix: |
|
Non-Proprietary Name: |
HYDROCODONE BITARTRATE, ACETAMINOPHEN |
Dosage Form: |
TABLET |
Method: |
ORAL |
Original Marketing Date: |
17-05-2012 |
Category Name: |
ANDA |
Application Number: |
ANDA040846 |
Labeler: |
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC |
Substance Name: |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
Active Numerator Strength: |
325; 2.5 |
Active Ingredient Unit: |
mg/1; mg/1 |
Pharm Classes: |
Opioid Agonist [EPC],Opioid Agonists [MoA] |
DEA Schedule: |
CIII |