Theophylline(Anhydrous)

Product NDC

16571-011

11-digit product format

165710011

Labeler code

16571

Product ID

16571-011_d3c75f8e-7b30-4536-862a-74e773853575

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Theophylline

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

Labeler

PACK Pharmaceuticals, LLC

Application

ANDA040595

Marketing category

ANDA

Marketing start

2010-09-15

Marketing end

0000-00-00

Substance

THEOPHYLLINE ANHYDROUS

Active strength

400 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