"70954-801-10" National Drug Code (NDC)

Tapentadol Hydrochloride 1 BOTTLE in 1 CARTON (70954-801-10) / 100 mL in 1 BOTTLE
(ANI Pharmaceuticals, Inc.)

NDC Code70954-801-10
Package Description1 BOTTLE in 1 CARTON (70954-801-10) / 100 mL in 1 BOTTLE
Product NDC70954-801
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameTapentadol Hydrochloride
Non-Proprietary NameTapentadol Hydrochloride
Dosage FormSOLUTION
UsageORAL
Start Marketing Date20260713
Marketing Category NameANDA
Application NumberANDA219119
ManufacturerANI Pharmaceuticals, Inc.
Substance NameTAPENTADOL HYDROCHLORIDE
Strength20
Strength Unitmg/mL
Pharmacy ClassesOpioid Agonist [EPC], Opioid Agonists [MoA]
DEA ScheduleCII

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