FDA.reportPublic FDA data

Terbutaline Sulfate

Product NDC
24979-132
11-digit product format
249790132
Labeler code
24979
Product ID
24979-132_3fd94b35-ef5a-4eb3-a3bd-0ce7572521d6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Terbutaline Sulfate
Dosage form
TABLET
Route
ORAL
Labeler
Upsher-Smith Laboratories, LLC
Application
ANDA211832
Marketing category
ANDA
Marketing start
2020-07-13
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
24979-132-012023-02-01C16284748780-1f386c64a-0993-0266-e053-dadaa90a7c1aTERBUTALINE SULFATE TABLETS, USP
24979-132-032023-02-01C16284748780-1f386c64a-0993-0266-e053-dadaa90a7c1aTERBUTALINE SULFATE TABLETS, USP
24979-132-012023-01-30C16284748780-1f386c64a-0993-0266-e053-dadaa90a7c1aTERBUTALINE SULFATE TABLETS, USP
24979-132-032023-01-30C16284748780-1f386c64a-0993-0266-e053-dadaa90a7c1aTERBUTALINE SULFATE TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24979-132-01Terbutaline Sulfate100 in 1 BOTTLETABLET1004
24979-132-03Terbutaline Sulfate1000 in 1 BOTTLETABLET10004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24979-132-01EA - Each24979-132c37a9008-5667-4ab9-877b-33a2df1dde5712020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24979-132TERBUTALINE SULFATE TABLET [TWI PHARMACEUTICALS, INC.]3Current NDC, Legacy NDC, 2 package rows20231202_3a4e5046-293c-4616-8679-6da65f31626b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857677terbutaline sulfate 2.5 MG Oral TabletPSN3a4e5046-293c-4616-8679-6da65f31626b4
857683terbutaline sulfate 5 MG Oral TabletPSN3a4e5046-293c-4616-8679-6da65f31626b4
857677terbutaline sulfate 2.5 MG Oral TabletSCD3a4e5046-293c-4616-8679-6da65f31626b4
857683terbutaline sulfate 5 MG Oral TabletSCD3a4e5046-293c-4616-8679-6da65f31626b4
857677terbutaline sulfate 2.5 MG Oral TabletPSN0a95bc4f-34d3-4b5e-841b-6839e1c1e0c72
857683terbutaline sulfate 5 MG Oral TabletPSN0a95bc4f-34d3-4b5e-841b-6839e1c1e0c72
857677terbutaline sulfate 2.5 MG Oral TabletSCD0a95bc4f-34d3-4b5e-841b-6839e1c1e0c72
857683terbutaline sulfate 5 MG Oral TabletSCD0a95bc4f-34d3-4b5e-841b-6839e1c1e0c72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
24979-132-0124979013201100 TABLET in 1 BOTTLE (24979-132-01) 100 tablet2020-07-130000-00-00NoNoCurrent
24979-132-03249790132031000 TABLET in 1 BOTTLE (24979-132-03) 1000 tablet2020-07-130000-00-00NoNoCurrent