FDA.reportPublic FDA data

Terbutaline Sulfate

Product NDC
10135-580
11-digit product format
101350580
Labeler code
10135
Product ID
10135-580_500ad3da-ce1b-4289-acdd-be3ec36577fb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Terbutaline Sulfate
Dosage form
TABLET
Route
ORAL
Labeler
Marlex Pharmaceuticals Inc
Application
ANDA077152
Marketing category
ANDA
Marketing start
2014-10-01
Marketing end
0000-00-00
Substance
TERBUTALINE SULFATE
Active strength
5 mg/1
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10135-580-012022-01-28C16284748780-1d6a99b39-517a-a426-e053-dadaa90af4c2Terbutaline Sulfate Tablets, USP
10135-580-102022-01-28C16284748780-1d6a99b39-517a-a426-e053-dadaa90af4c2Terbutaline Sulfate Tablets, USP
10135-580-322022-01-28C16284748780-1d6a99b39-517a-a426-e053-dadaa90af4c2Terbutaline Sulfate Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10135-580-01Terbutaline Sulfate100 in 1 BOTTLETABLET1003
10135-580-10Terbutaline Sulfate1000 in 1 BOTTLETABLET10003
10135-580-32Terbutaline Sulfate180 in 1 BOTTLETABLET1803

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10135-580-01EA - Each10135-580d6d32a38-f994-4a2a-8a6e-f39a7d31334112015-04-03
10135-580-32EA - Each10135-580e5a662d5-4265-49a7-9871-37024aa6a83612015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TERBUTALINE SULFATEACTIVE INGREDIENT576PU70Y8ETERBUTALINE SULFATE TABLET [MARLEX PHARMACEUTICALS INC]1
TERBUTALINEACTIVE MOIETYN8ONU3L3PGTERBUTALINE SULFATE TABLET [MARLEX PHARMACEUTICALS INC]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTERBUTALINE SULFATE TABLET [MARLEX PHARMACEUTICALS INC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTERBUTALINE SULFATE TABLET [MARLEX PHARMACEUTICALS INC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TERBUTALINE SULFATE TABLET [MARLEX PHARMACEUTICALS INC]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ETERBUTALINE SULFATE TABLET [MARLEX PHARMACEUTICALS INC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTERBUTALINE SULFATE TABLET [MARLEX PHARMACEUTICALS INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10135-580TERBUTALINE SULFATE TABLET [MARLEX PHARMACEUTICALS INC]3Legacy NDC, 3 package rows20200107_94742710-e87e-4e1c-85ee-0a2e7a77f0de.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857677terbutaline sulfate 2.5 MG Oral TabletPSN94742710-e87e-4e1c-85ee-0a2e7a77f0de3
857683terbutaline sulfate 5 MG Oral TabletPSN94742710-e87e-4e1c-85ee-0a2e7a77f0de3
857677terbutaline sulfate 2.5 MG Oral TabletSCD94742710-e87e-4e1c-85ee-0a2e7a77f0de3
857683terbutaline sulfate 5 MG Oral TabletSCD94742710-e87e-4e1c-85ee-0a2e7a77f0de3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10135-580-0110135058001100 TABLET in 1 BOTTLE (10135-580-01) 100 tablet2014-10-010000-00-00NoNoCurrent
10135-580-10101350580101000 TABLET in 1 BOTTLE (10135-580-10) 1000 tablet2014-10-010000-00-00NoNoCurrent
10135-580-3210135058032180 TABLET in 1 BOTTLE (10135-580-32) 180 tablet2014-10-010000-00-00NoNoCurrent