"82638-105-02" National Drug Code (NDC)

Theophylline 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (82638-105-02)
(Harman Finochem Limited)

NDC Code82638-105-02
Package Description100 TABLET, EXTENDED RELEASE in 1 BOTTLE (82638-105-02)
Product NDC82638-105
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameTheophylline
Non-Proprietary NameTheophylline
Dosage FormTABLET, EXTENDED RELEASE
UsageORAL
Start Marketing Date20240531
Marketing Category NameANDA
Application NumberANDA214806
ManufacturerHarman Finochem Limited
Substance NameTHEOPHYLLINE ANHYDROUS
Strength300
Strength Unitmg/1
Pharmacy ClassesMethylxanthine [EPC], Xanthines [CS]

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