Theophylline
Theophylline (Anhydrous) Extended-Release Tablets 400 mg and 600 mg Rx only
Approved
Approval ID
def63108-2e96-446c-a7a8-a65d54de2859
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 6, 2017
Manufacturers
FDA
Carilion Materials Management
DUNS: 079239644
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Theophylline
PRODUCT DETAILS
NDC Product Code68151-0667
Application NumberANDA087571
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 21, 2015
Generic NameTheophylline
INGREDIENTS (6)
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
THEOPHYLLINE ANHYDROUSActive
Quantity: 400 mg in 1 1
Code: 0I55128JYK
Classification: ACTIB
CETOSTEARYL ALCOHOLInactive
Code: 2DMT128M1S
Classification: IACT
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)Inactive
Code: S38J6RZN16
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT