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Roxicet - Oxycodone and Acetaminophen

Navigation: NDC > Supplier starting with: R > ROXANE LABORATORIES, INC.
Field Value
NDC Code: 0054-8648
Proprietary Name: Roxicet
Suffix:
Non-Proprietary Name: Oxycodone and Acetaminophen
Dosage Form: SOLUTION
Method: ORAL
Original Marketing Date: 17-01-1991
Category Name: ANDA
Application Number: ANDA089351
Labeler: ROXANE LABORATORIES, INC.
Substance Name: ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Active Numerator Strength: 325; 5
Active Ingredient Unit: mg/5mL; mg/5mL
Pharm Classes: Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA Schedule: CII