Theophylline

Product NDC

50111-518

11-digit product format

501110518

Labeler code

50111

Product ID

50111-518_7ead0af5-da03-4e84-8685-f469cfde4855

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Theophylline

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

Labeler

Teva Pharmaceuticals USA, Inc.

Application

ANDA081236

Marketing category

ANDA

Marketing start

2010-09-13

Marketing end

0000-00-00

Substance

THEOPHYLLINE ANHYDROUS

Active strength

450 mg/1

Pharmacologic classes

Methylxanthine [EPC],Xanthines [CS]

NDC exclude flag

No

Listing certified through

2019-12-31

Current FDA listing

Historical FDA.report record