Theophylline
Theophylline Extended-Release Tablets Rx only
Approved
Approval ID
25eabefa-518b-4030-9b72-01ac8b3deba9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 4, 2023
Manufacturers
FDA
Teva Pharmaceuticals, Inc.
DUNS: 022629579
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 Code0480-3309
Application NumberANDA216961
Product Classification
M
Marketing Category
C73584
G
Generic Name
Theophylline
Product Specifications
Route of AdministrationORAL
Effective DateDecember 4, 2023
FDA Product Classification
INGREDIENTS (5)
THEOPHYLLINEActive
Quantity: 450 mg in 1 1
Code: C137DTR5RG
Classification: ACTIM
HYPROMELLOSE 2208 (100 MPA.S)Inactive
Code: B1QE5P712K
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
Theophylline
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0480-3310
Application NumberANDA216961
Product Classification
M
Marketing Category
C73584
G
Generic Name
Theophylline
Product Specifications
Route of AdministrationORAL
Effective DateDecember 4, 2023
FDA Product Classification
INGREDIENTS (5)
THEOPHYLLINEActive
Quantity: 300 mg in 1 1
Code: C137DTR5RG
Classification: ACTIM
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
HYPROMELLOSE 2208 (100 MPA.S)Inactive
Code: B1QE5P712K
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT