"52427-692-03" National Drug Code (NDC)

Buprenorphine And Naloxone 30 POUCH in 1 CARTON (52427-692-03) > 1 FILM in 1 POUCH (52427-692-11)
(Almatica Pharma Inc.)

NDC Code52427-692-03
Package Description30 POUCH in 1 CARTON (52427-692-03) > 1 FILM in 1 POUCH (52427-692-11)
Product NDC52427-692
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameBuprenorphine And Naloxone
Proprietary Name SuffixSublingual Film
Non-Proprietary NameBuprenorphine And Naloxone
Dosage FormFILM
UsageBUCCAL; SUBLINGUAL
Start Marketing Date20190211
Marketing Category NameANDA
Application NumberANDA205954
ManufacturerAlmatica Pharma Inc.
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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