THEOPHYLLINE
THEOPHYLLINE ORAL SOLUTION USP
Approved
Approval ID
32b9780f-c46f-4e0f-9641-2cab60600e6e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 11, 2023
Manufacturers
FDA
PAI Holdings, LLC
DUNS: 044940096
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 Code0121-0820
Application NumberANDA206344
Product Classification
M
Marketing Category
C73584
G
Generic Name
THEOPHYLLINE
Product Specifications
Route of AdministrationORAL
Effective DateAugust 11, 2023
FDA Product Classification
INGREDIENTS (7)
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
THEOPHYLLINEActive
Quantity: 80 mg in 15 mL
Code: C137DTR5RG
Classification: ACTIM
THEOPHYLLINE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0121-4820
Application NumberANDA206344
Product Classification
M
Marketing Category
C73584
G
Generic Name
THEOPHYLLINE
Product Specifications
Route of AdministrationORAL
Effective DateAugust 11, 2023
FDA Product Classification
INGREDIENTS (7)
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
THEOPHYLLINEActive
Quantity: 80 mg in 15 mL
Code: C137DTR5RG
Classification: ACTIM
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT