"60846-971-03" National Drug Code (NDC)

Buprenorphine And Naloxone 30 TABLET in 1 BOTTLE (60846-971-03)
(Gemini Laboratories, LLC)

NDC Code60846-971-03
Package Description30 TABLET in 1 BOTTLE (60846-971-03)
Product NDC60846-971
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameBuprenorphine And Naloxone
Non-Proprietary NameBuprenorphine And Naloxone
Dosage FormTABLET
UsageSUBLINGUAL
Start Marketing Date20130222
Marketing Category NameANDA
Application NumberANDA203136
ManufacturerGemini Laboratories, LLC
Substance NameBUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE
Strength8; 2
Strength Unitmg/1; mg/1
Pharmacy ClassesPartial Opioid Agonists [MoA],Partial Opioid Agonist [EPC],Opioid Antagonist [EPC],Opioid Antagonists [MoA]
DEA ScheduleCIII

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