Theophylline Extended Release

Product NDC

0615-2503

11-digit product format

006152503

Labeler code

0615

Product ID

0615-2503_282f24d5-31de-4b2e-8262-361119501b12

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Theophylline, anhydrous

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

Labeler

NCS HealthCare of KY, Inc dba Vangard Labs

Application

ANDA089808

Marketing category

ANDA

Marketing start

1990-04-30

Marketing end

0000-00-00

Substance

THEOPHYLLINE

Active strength

200 mg/1

Pharmacologic classes

Methylxanthine [EPC],Xanthines [CS]

NDC exclude flag

E

Listing certified through

2017-12-31

Current FDA listing

Historical FDA.report record