Theophylline
Theophylline
Approved
Approval ID
02fcc06e-2a81-404f-a7cd-313fcb0d833c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 18, 2019
Manufacturers
FDA
Marlex Pharmaceuticals Inc
DUNS: 782540215
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Theophylline Anhydrous
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code10135-604
Application NumberANDA091156
Product Classification
M
Marketing Category
C73584
G
Generic Name
Theophylline Anhydrous
Product Specifications
Route of AdministrationORAL
Effective DateOctober 25, 2019
FDA Product Classification
INGREDIENTS (8)
THEOPHYLLINE ANHYDROUSActive
Quantity: 80 mg in 15 mL
Code: 0I55128JYK
Classification: ACTIB
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT