ELIXOPHYLLIN
ELIXOPHYLLIN Elixir(Theophylline Oral Solution, USP)(brand of theophylline anhydrous)Rx Only
Approved
Approval ID
b488f996-2f80-438a-8333-b837f9acd4fc
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 13, 2018
Manufacturers
FDA
Nostrum Laboratories, Inc.
DUNS: 791055549
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 Code70408-644
Application NumberANDA085186
Product Classification
M
Marketing Category
C73584
G
Generic Name
THEOPHYLLINE ANHYDROUS
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 29, 2016
FDA Product Classification
INGREDIENTS (7)
THEOPHYLLINE ANHYDROUSActive
Quantity: 80 mg in 15 mL
Code: 0I55128JYK
Classification: ACTIB
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT