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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code46708-026
Application NumberANDA090430
Product Classification
M
Marketing Category
C73584
G
Generic Name
Theophylline
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 11, 2023
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code46708-025
Application NumberANDA090430
Product Classification
M
Marketing Category
C73584
G
Generic Name
Theophylline
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 11, 2023
FDA Product Classification
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