"0378-2661-05" National Drug Code (NDC)

Morphine Sulfate 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-2661-05)
(Mylan Pharmaceuticals Inc.)

NDC Code0378-2661-05
Package Description500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-2661-05)
Product NDC0378-2661
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameMorphine Sulfate
Non-Proprietary NameMorphine Sulfate
Dosage FormTABLET, FILM COATED, EXTENDED RELEASE
UsageORAL
Start Marketing Date20130319
Marketing Category NameANDA
Application NumberANDA200824
ManufacturerMylan Pharmaceuticals Inc.
Substance NameMORPHINE SULFATE
Strength100
Strength Unitmg/1
Pharmacy ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII

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