"76519-1170-3" National Drug Code (NDC)

Buprenorphine Hcl 70 TABLET in 1 BOTTLE (76519-1170-3)
(H.J. Harkins Company, Inc.)

NDC Code76519-1170-3
Package Description70 TABLET in 1 BOTTLE (76519-1170-3)
Product NDC76519-1170
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameBuprenorphine Hcl
Proprietary Name SuffixSl
Non-Proprietary NameBuprenorphine Hcl
Dosage FormTABLET
UsageSUBLINGUAL
Start Marketing Date20180316
Marketing Category NameANDA
Application NumberANDA078633
ManufacturerH.J. Harkins Company, Inc.
Substance NameBUPRENORPHINE HYDROCHLORIDE
Strength8
Strength Unitmg/1
Pharmacy ClassesPartial Opioid Agonists [MoA],Partial Opioid Agonist [EPC]
DEA ScheduleCIII

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