"0121-2038-30" National Drug Code (NDC)

Buprenorphine Hydrochloride 30 TABLET in 1 BOTTLE (0121-2038-30)
(PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma)

NDC Code0121-2038-30
Package Description30 TABLET in 1 BOTTLE (0121-2038-30)
Product NDC0121-2038
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 Pharmaceutical Associates, Inc. and dba PAI Pharma
Substance NameBUPRENORPHINE HYDROCHLORIDE
Strength8
Strength Unitmg/1
Pharmacy ClassesPartial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]
DEA ScheduleCIII

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