Theophylline
Theophylline Extended-Release Tablets Rx only
Approved
Approval ID
48330a8e-be08-4d38-b8b1-d30fbd5a35de
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 4, 2021
Manufacturers
FDA
Glenmark Pharmaceuticals Inc., USA
DUNS: 130597813
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 Code68462-721
Application NumberANDA212184
Product Classification
M
Marketing Category
C73584
G
Generic Name
Theophylline
Product Specifications
Route of AdministrationORAL
Effective DateJune 4, 2021
FDA Product Classification
INGREDIENTS (6)
THEOPHYLLINE ANHYDROUSActive
Quantity: 300 mg in 1 1
Code: 0I55128JYK
Classification: ACTIB
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POVIDONE K90Inactive
Code: RDH86HJV5Z
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
Theophylline
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68462-722
Application NumberANDA212184
Product Classification
M
Marketing Category
C73584
G
Generic Name
Theophylline
Product Specifications
Route of AdministrationORAL
Effective DateJune 4, 2021
FDA Product Classification
INGREDIENTS (6)
THEOPHYLLINE ANHYDROUSActive
Quantity: 450 mg in 1 1
Code: 0I55128JYK
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
POVIDONE K90Inactive
Code: RDH86HJV5Z
Classification: IACT