Theophylline

Product NDC
68999-556
11-digit product format
689990556
Labeler code
68999
Product ID
68999-556_43905546-0c51-ab49-e063-6294a90a4a31
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Theophylline
Dosage form
SOLUTION
Route
ORAL
Labeler
Chartwell Governmental & Specialty RX, LLC.
Application
ANDA091156
Marketing category
ANDA
Marketing start
2011-04-13
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
68999-556-24Theophylline10 in 1 TRAYSOLUTION101
68999-556-24Theophylline2 in 1 BOXSOLUTION21
68999-556-51Theophylline15 mL in 1 CUPSOLUTION151

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68999-556-24ML - Milliliter68999-5567368f7a6-331f-4683-a87c-b64c5bb7d65812026-03-17
68999-556-51ML - Milliliter68999-556bea0678d-7f28-411b-adb6-deab7adb434312026-03-17

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313306theophylline 80 MG in 15 mL Oral SolutionPSNe2716dac-8b23-4e06-bc3e-4dd76b7c813e1
313306theophylline 5.33 MG/ML Oral SolutionSCDe2716dac-8b23-4e06-bc3e-4dd76b7c813e1
313306theophylline 100 MG per 18.75 ML Oral SolutionSYe2716dac-8b23-4e06-bc3e-4dd76b7c813e1
313306theophylline 80 MG per 15 ML Oral SolutionSYe2716dac-8b23-4e06-bc3e-4dd76b7c813e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68999-556-24689990556242 TRAY in 1 BOX (68999-556-24) / 10 CUP in 1 TRAY / 15 mL in 1 CUP (68999-556-51) 2 tray2025-11-13NoNoHistorical
68999-556-516899905565115 mL in 1 CUP15 mlHistorical