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

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
72162-2038-2Theophylline473 mL in 1 BOTTLESOLUTION473101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2038-2ML - Milliliter72162-2038afc083da-c670-40fe-b7c7-0104051b4d3512023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2038THEOPHYLLINE SOLUTION [BRYANT RANCH PREPACK]101Current NDC, 1 package rows20241122_955dba5e-c3b7-4a45-8650-e1b4722dbaea.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313306theophylline 80 MG in 15 mL Oral SolutionPSN955dba5e-c3b7-4a45-8650-e1b4722dbaea101
313306theophylline 5.33 MG/ML Oral SolutionSCD955dba5e-c3b7-4a45-8650-e1b4722dbaea101
313306theophylline 100 MG per 18.75 ML Oral SolutionSY955dba5e-c3b7-4a45-8650-e1b4722dbaea101
313306theophylline 80 MG per 15 ML Oral SolutionSY955dba5e-c3b7-4a45-8650-e1b4722dbaea101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2038-272162203802473 mL in 1 BOTTLE (72162-2038-2) 473 ml2023-06-06NoNoCurrent