"0378-0486-01" National Drug Code (NDC)

Theophylline 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-0486-01)
(Mylan Pharmaceuticals Inc.)

NDC Code0378-0486-01
Package Description100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-0486-01)
Product NDC0378-0486
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameTheophylline
Proprietary Name Suffix(anhydrous)
Non-Proprietary NameTheophylline
Dosage FormTABLET, EXTENDED RELEASE
UsageORAL
Start Marketing Date20170307
End Marketing Date20220731
Marketing Category NameANDA
Application NumberANDA040560
ManufacturerMylan Pharmaceuticals Inc.
Substance NameTHEOPHYLLINE ANHYDROUS
Strength400
Strength Unitmg/1
Pharmacy ClassesMethylxanthine [EPC], Xanthines [CS]

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