ULTRACET - tramadol hydrochloride and acetaminophen
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Field |
Value |
NDC Code: |
55289-617 |
Proprietary Name: |
ULTRACET |
Suffix: |
|
Non-Proprietary Name: |
tramadol hydrochloride and acetaminophen |
Dosage Form: |
TABLET, COATED |
Method: |
ORAL |
Original Marketing Date: |
15-08-2001 |
Category Name: |
NDA |
Application Number: |
NDA021123 |
Labeler: |
PD RX PHARMACEUTICALS, INC. |
Substance Name: |
ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE |
Active Numerator Strength: |
325; 37.5 |
Active Ingredient Unit: |
mg/1; mg/1 |
Pharm Classes: |
Full Opioid Agonists [MoA],Opioid Agonist [EPC] |
DEA Schedule: |
|