Theophylline
Theophylline Extended-Release Tablets Rx only
Approved
Approval ID
6bc8923e-b7db-40a5-b22a-a975ca2bf1fd
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 28, 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 Code68151-1393
Application NumberANDA090430
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 5, 2016
Generic NameTheophylline
INGREDIENTS (5)
THEOPHYLLINE ANHYDROUSActive
Quantity: 300 mg in 1 1
Code: 0I55128JYK
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT