Uniphyl
UNIPHYL Tablets(theophylline, anhydrous)400 mg and 600 mgUNICONTIN Controlled-Release System
Approved
Approval ID
c4c80b87-fc6e-436d-84de-7a0cd9d895eb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 24, 2011
Manufacturers
FDA
Purdue Pharmaceutical Products LP
DUNS: 138922641
Products 2
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 Code67781-252
Application NumberANDA040086
Product Classification
M
Marketing Category
C73584
G
Generic Name
theophylline anhydrous
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 19, 2011
FDA Product Classification
INGREDIENTS (6)
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
cetostearyl alcoholInactive
Code: 2DMT128M1S
Classification: IACT
theophylline anhydrousActive
Quantity: 600 mg in 1 1
Code: 0I55128JYK
Classification: ACTIB
hydroxyethyl cellulose (2000 CPS at 1%)Inactive
Code: S38J6RZN16
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT
povidoneInactive
Code: FZ989GH94E
Classification: IACT
theophylline anhydrous
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67781-251
Application NumberANDA087571
Product Classification
M
Marketing Category
C73584
G
Generic Name
theophylline anhydrous
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 19, 2011
FDA Product Classification
INGREDIENTS (6)
theophylline anhydrousActive
Quantity: 400 mg in 1 1
Code: 0I55128JYK
Classification: ACTIB
cetostearyl alcoholInactive
Code: 2DMT128M1S
Classification: IACT
hydroxyethyl cellulose (2000 CPS at 1%)Inactive
Code: S38J6RZN16
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
povidoneInactive
Code: FZ989GH94E
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT