Theophylline Extended Release

Product NDC

0615-1590

11-digit product format

006151590

Labeler code

0615

Product ID

0615-1590_9864e22b-201f-455d-9361-786fad14bb2f

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

ANDA089763

Marketing category

ANDA

Marketing start

1990-04-30

Marketing end

0000-00-00

Substance

THEOPHYLLINE

Active strength

300 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