Theophylline
Theophylline Extended-Release Tablets
Approved
Approval ID
699a4e05-95cb-4b28-8927-d97a4afbf463
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 23, 2011
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 3
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 Code54868-1461
Application NumberANDA089807
Product Classification
M
Marketing Category
C73584
G
Generic Name
Theophylline
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 23, 2011
FDA Product Classification
INGREDIENTS (6)
THEOPHYLLINE ANHYDROUSActive
Quantity: 100 mg in 1 1
Code: 0I55128JYK
Classification: ACTIB
HYPROMELLOSE 2208 (100 MPA.S)Inactive
Code: B1QE5P712K
Classification: IACT
HYPROMELLOSE 2208 (100000 MPA.S)Inactive
Code: VM7F0B23ZI
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Theophylline
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-0028
Application NumberANDA089808
Product Classification
M
Marketing Category
C73584
G
Generic Name
Theophylline
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 23, 2011
FDA Product Classification
INGREDIENTS (6)
HYPROMELLOSE 2208 (100 MPA.S)Inactive
Code: B1QE5P712K
Classification: IACT
THEOPHYLLINE ANHYDROUSActive
Quantity: 200 mg in 1 1
Code: 0I55128JYK
Classification: ACTIB
HYPROMELLOSE 2208 (100000 MPA.S)Inactive
Code: VM7F0B23ZI
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
Theophylline
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-0029
Application NumberANDA089763
Product Classification
M
Marketing Category
C73584
G
Generic Name
Theophylline
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 23, 2011
FDA Product Classification
INGREDIENTS (6)
THEOPHYLLINE ANHYDROUSActive
Quantity: 300 mg in 1 1
Code: 0I55128JYK
Classification: ACTIB
HYPROMELLOSE 2208 (100 MPA.S)Inactive
Code: B1QE5P712K
Classification: IACT
HYPROMELLOSE 2208 (100000 MPA.S)Inactive
Code: VM7F0B23ZI
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT