MedPath

Theophylline

Theophylline Extended-Release Tablets

Approved
Approval ID

f93e20b1-97aa-088d-e053-6394a90a25d4

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Apr 13, 2023

Manufacturers
FDA

AvKARE

DUNS: 796560394

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Theophylline

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code42291-922
Application NumberANDA089763
Product Classification
M
Marketing Category
C73584
G
Generic Name
Theophylline
Product Specifications
Route of AdministrationORAL
Effective DateApril 13, 2023
FDA Product Classification

INGREDIENTS (5)

HYPROMELLOSE 2208 (100 MPA.S)Inactive
Code: B1QE5P712K
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
THEOPHYLLINE ANHYDROUSActive
Quantity: 300 mg in 1 1
Code: 0I55128JYK
Classification: ACTIB

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Theophylline - FDA Drug Approval Details