FDA.reportPublic FDA data

Theo-24

Product NDC
52244-100
11-digit product format
522440100
Labeler code
52244
Product ID
52244-100_95d19693-50ba-43fc-81fe-6cddc537703a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
theophylline anhydrous
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
ENDO USA, Inc.
Application
ANDA087942
Marketing category
ANDA
Marketing start
2014-08-25
Substance
THEOPHYLLINE ANHYDROUS
Active strength
100 mg/1
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
Theo-24
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
THEOPHYLLINE ANHYDROUS100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0I55128JYK
Rxcui198264, 313272, 313310, 701712, 844590, 844591, 844813, 844829

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
52244-100-10Theo-24100 in 1 BOTTLECAPSULE, EXTENDED RELEASE10011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52244-100THEO-24 (THEOPHYLLINE ANHYDROUS) CAPSULE, EXTENDED RELEASE [ENDO USA, INC.]11Current NDC, Legacy NDC, 1 package rows20240709_7a108fa0-c230-475f-be93-6f864b98a410.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
844590Theo-24 100 MG Extended Release Oral CapsulePSN7a108fa0-c230-475f-be93-6f864b98a41011
844813Theo-24 200 MG Extended Release Oral CapsulePSN7a108fa0-c230-475f-be93-6f864b98a41011
844591Theo-24 300 MG Extended Release Oral CapsulePSN7a108fa0-c230-475f-be93-6f864b98a41011
844829Theo-24 400 MG Extended Release Oral CapsulePSN7a108fa0-c230-475f-be93-6f864b98a41011
701712theophylline 100 MG Extended Release Oral CapsulePSN7a108fa0-c230-475f-be93-6f864b98a41011
313272theophylline 200 MG Extended Release Oral CapsulePSN7a108fa0-c230-475f-be93-6f864b98a41011
313310theophylline 300 MG Extended Release Oral CapsulePSN7a108fa0-c230-475f-be93-6f864b98a41011
198264theophylline 400 MG Extended Release Oral CapsulePSN7a108fa0-c230-475f-be93-6f864b98a41011
844590theophylline 100 MG Extended Release Oral Capsule [Theo-24]SBD7a108fa0-c230-475f-be93-6f864b98a41011
844813theophylline 200 MG Extended Release Oral Capsule [Theo-24]SBD7a108fa0-c230-475f-be93-6f864b98a41011
844591theophylline 300 MG Extended Release Oral Capsule [Theo-24]SBD7a108fa0-c230-475f-be93-6f864b98a41011
844829theophylline 400 MG Extended Release Oral Capsule [Theo-24]SBD7a108fa0-c230-475f-be93-6f864b98a41011
701712theophylline 100 MG Extended Release Oral CapsuleSCD7a108fa0-c230-475f-be93-6f864b98a41011
313272theophylline 200 MG Extended Release Oral CapsuleSCD7a108fa0-c230-475f-be93-6f864b98a41011
313310theophylline 300 MG Extended Release Oral CapsuleSCD7a108fa0-c230-475f-be93-6f864b98a41011
198264theophylline 400 MG Extended Release Oral CapsuleSCD7a108fa0-c230-475f-be93-6f864b98a41011
844590Theo-24 100 MG Extended Release Oral CapsuleSY7a108fa0-c230-475f-be93-6f864b98a41011
844813Theo-24 200 MG Extended Release Oral CapsuleSY7a108fa0-c230-475f-be93-6f864b98a41011
844591Theo-24 300 MG Extended Release Oral CapsuleSY7a108fa0-c230-475f-be93-6f864b98a41011
844829Theo-24 400 MG Extended Release Oral CapsuleSY7a108fa0-c230-475f-be93-6f864b98a41011

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
52244-100-1052244010010100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (52244-100-10) 2014-08-250000-00-00NoNoCurrent