"0378-1712-05" National Drug Code (NDC)

Pramipexole Dihydrochloride 500 TABLET in 1 BOTTLE, PLASTIC (0378-1712-05)
(Mylan Pharmaceuticals Inc.)

NDC Code0378-1712-05
Package Description500 TABLET in 1 BOTTLE, PLASTIC (0378-1712-05)
Product NDC0378-1712
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NamePramipexole Dihydrochloride
Non-Proprietary NamePramipexole Dihydrochloride
Dosage FormTABLET
UsageORAL
Start Marketing Date20101104
Marketing Category NameANDA
Application NumberANDA077854
ManufacturerMylan Pharmaceuticals Inc.
Substance NamePRAMIPEXOLE DIHYDROCHLORIDE
Strength1.5
Strength Unitmg/1
Pharmacy ClassesDopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]

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