"43386-543-05" National Drug Code (NDC)

Morphine Sulfate 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (43386-543-05)
(Lupin Pharmaceuticals,Inc.)

NDC Code43386-543-05
Package Description500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (43386-543-05)
Product NDC43386-543
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameMorphine Sulfate
Non-Proprietary NameMorphine Sulfate
Dosage FormTABLET, FILM COATED, EXTENDED RELEASE
UsageORAL
Start Marketing Date20151216
Marketing Category NameANDA
Application NumberANDA203602
ManufacturerLupin Pharmaceuticals,Inc.
Substance NameMORPHINE SULFATE
Strength100
Strength Unitmg/1
Pharmacy ClassesFull Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA ScheduleCII

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