"0121-1019-30" National Drug Code (NDC)

Buprenorphine Hydrochloride 30 TABLET in 1 BOTTLE (0121-1019-30)
(PAI Holdings, LLC dba PAI Pharma)

NDC Code0121-1019-30
Package Description30 TABLET in 1 BOTTLE (0121-1019-30)
Product NDC0121-1019
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameBuprenorphine Hydrochloride
Non-Proprietary NameBuprenorphine Hydrochloride
Dosage FormTABLET
UsageSUBLINGUAL
Start Marketing Date20231012
Marketing Category NameANDA
Application NumberANDA090622
ManufacturerPAI Holdings, LLC dba PAI Pharma
Substance NameBUPRENORPHINE HYDROCHLORIDE
Strength2
Strength Unitmg/1
Pharmacy ClassesPartial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]
DEA ScheduleCIII

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