Terbutaline Sulfate

Product NDC
62135-524
11-digit product format
621350524
Labeler code
62135
Product ID
62135-524_459ef32e-2348-14bd-e063-6394a90a6a90
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Terbutaline Sulfate
Dosage form
TABLET
Route
ORAL
Labeler
Chartwell RX, LLC.
Application
ANDA077152
Marketing category
ANDA
Marketing start
2005-03-25
Substance
TERBUTALINE SULFATE
Active strength
2.5 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TERBUTALINE SULFATE2.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii576PU70Y8E
Rxcui857677, 857683

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
49ccb555-d142-0761-ee45-2e1304b37b1dProduct name220210111
a3c04a67-87ea-e8b8-0458-db8085ac6340Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62135-524-90Terbutaline Sulfate90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-524-90EA - Each62135-524b14e44ae-90f0-4a2f-a715-fca11470c9ea12023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-524TERBUTALINE SULFATE TABLET [CHARTWELL RX, LLC.]1Current NDC, 1 package rows20230306_859267c6-3d14-4123-9b9d-4fc248f09726.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857677terbutaline sulfate 2.5 MG Oral TabletPSN859267c6-3d14-4123-9b9d-4fc248f097262
857683terbutaline sulfate 5 MG Oral TabletPSN859267c6-3d14-4123-9b9d-4fc248f097262
857677terbutaline sulfate 2.5 MG Oral TabletSCD859267c6-3d14-4123-9b9d-4fc248f097262
857683terbutaline sulfate 5 MG Oral TabletSCD859267c6-3d14-4123-9b9d-4fc248f097262

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62135-524-906213505249090 TABLET in 1 BOTTLE (62135-524-90) 90 tablet2023-02-28NoNoHistorical