THEOPHYLLINE
Theophylline Extended-Release Tablets
Approved
Approval ID
90cdb3d4-3f0b-4a29-9cdf-278f4f588ce1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 17, 2023
Manufacturers
FDA
Rhodes Pharmaceuticals
DUNS: 831928986
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 Code42858-700
Application NumberANDA214113
Product Classification
M
Marketing Category
C73584
G
Generic Name
THEOPHYLLINE ANHYDROUS
Product Specifications
Route of AdministrationORAL
Effective DateMay 17, 2023
FDA Product Classification
INGREDIENTS (6)
HYPROMELLOSE 2910 (15000 MPA.S)Inactive
Code: 288VBX44JC
Classification: IACT
THEOPHYLLINE ANHYDROUSActive
Quantity: 300 mg in 1 1
Code: 0I55128JYK
Classification: ACTIB
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT