Theophylline
Theophylline Extended-Release Tablets Rx only
Approved
Approval ID
31f3c720-1597-4d43-9296-33017b90b15f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 11, 2023
Manufacturers
FDA
Alembic Pharmaceuticals Limited
DUNS: 650574663
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Theophylline
PRODUCT DETAILS
NDC Product Code46708-026
Application NumberANDA090430
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 11, 2023
Generic NameTheophylline
INGREDIENTS (5)
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
THEOPHYLLINE ANHYDROUSActive
Quantity: 450 mg in 1 1
Code: 0I55128JYK
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
Theophylline
PRODUCT DETAILS
NDC Product Code46708-025
Application NumberANDA090430
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 11, 2023
Generic NameTheophylline
INGREDIENTS (5)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
THEOPHYLLINE ANHYDROUSActive
Quantity: 300 mg in 1 1
Code: 0I55128JYK
Classification: ACTIB
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT