Theophylline

Product NDC
72162-2038
11-digit product format
721622038
Labeler code
72162
Product ID
72162-2038_601b3954-8a02-425f-abb9-100069663c9a
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
72162-2038-272162203802473 mL in 1 BOTTLE (72162-2038-2) 473 ml2023-06-06NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Theophylline Oral Solution, USP 80 mg/15 mL Rx OnlyBryant Ranch Prepack2024-11-20HUMAN PRESCRIPTION DRUG LABEL101