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

Additional Listing Data#

Finished product
Yes
Brand name base
Theophylline
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
THEOPHYLLINE ANHYDROUS80 mg/15mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0I55128JYK
Rxcui313306

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1d07c79-5983-427d-b6f5-df0550dcc598Product name420250325
7b1e3dc0-e6b1-4d5d-943b-99fdd948b5a2Product name120170302

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2909-1Theophylline473 mL in 1 BOTTLESOLUTION473100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2909-1ML - Milliliter71335-2909c32ae807-4700-4ec2-a41d-879905dea95712026-01-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313306theophylline 80 MG in 15 mL Oral SolutionPSN62fb84a9-4e75-4f4b-8f15-1fd1bb7ae4dd100
313306theophylline 5.33 MG/ML Oral SolutionSCD62fb84a9-4e75-4f4b-8f15-1fd1bb7ae4dd100
313306theophylline 100 MG per 18.75 ML Oral SolutionSY62fb84a9-4e75-4f4b-8f15-1fd1bb7ae4dd100
313306theophylline 80 MG per 15 ML Oral SolutionSY62fb84a9-4e75-4f4b-8f15-1fd1bb7ae4dd100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2909-171335290901473 mL in 1 BOTTLE (71335-2909-1) 473 ml2025-10-22NoNoCurrent