Theophylline

Product NDC

0121-4794

11-digit product format

001214794

Labeler code

0121

Product ID

0121-4794_d0cc7207-c3ca-4f0b-99b6-82409a0a0255

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

THEOPHYLLINE ANHYDROUS

Dosage form

SOLUTION

Route

ORAL

Labeler

Pharmaceutical Associates, Inc.

Application

ANDA085186

Marketing category

ANDA

Marketing start

2008-11-03

Marketing end

0000-00-00

Substance

THEOPHYLLINE ANHYDROUS

Active strength

80 mg/15mL

Pharmacologic classes

Methylxanthine [EPC],Xanthines [CS]

NDC exclude flag

E

Listing certified through

2017-12-31

Current FDA listing

Historical FDA.report record