Theophylline

Product NDC
71335-2909
11-digit product format
713352909
Labeler code
71335
Product ID
71335-2909_8f5bdf04-0913-42db-8349-7121a814b909
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Theophylline
Dosage form
SOLUTION
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA091586
Marketing category
ANDA
Marketing start
2012-08-02
Substance
THEOPHYLLINE ANHYDROUS
Active strength
80 mg/15mL
Pharmacologic classes
Methylxanthine [EPC], Xanthines [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
0I55128JYKTHEOPHYLLINE ANHYDROUS58-55-9THEOPHYLLINE ANHYDROUS
C137DTR5RGTHEOPHYLLINE5967-84-0Theophylline

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2909-171335290901473 mL in 1 BOTTLE (71335-2909-1) 473 ml2025-10-22NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Theophylline Oral Solution, USP 80 mg/15 mL Rx OnlyBryant Ranch Prepack2025-10-22HUMAN PRESCRIPTION DRUG LABEL100