"65162-416-09" National Drug Code (NDC)

Buprenorphine Hcl And Naloxone Hcl 90 TABLET in 1 BOTTLE (65162-416-09)
(Amneal Pharmaceuticals LLC)

NDC Code65162-416-09
Package Description90 TABLET in 1 BOTTLE (65162-416-09)
Product NDC65162-416
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameBuprenorphine Hcl And Naloxone Hcl
Non-Proprietary NameBuprenorphine And Naloxone
Dosage FormTABLET
UsageSUBLINGUAL
Start Marketing Date20130222
Marketing Category NameANDA
Application NumberANDA203136
ManufacturerAmneal Pharmaceuticals LLC
Substance NameBUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE
Strength2; .5
Strength Unitmg/1; mg/1
Pharmacy ClassesOpioid Antagonist [EPC], Opioid Antagonists [MoA], Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]
DEA ScheduleCIII

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