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
NDC Product Code0121-0820
Application NumberANDA206344
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateAugust 11, 2023
Generic NameTHEOPHYLLINE
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
NDC Product Code0121-4820
Application NumberANDA206344
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateAugust 11, 2023
Generic NameTHEOPHYLLINE
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