FDA.reportPublic FDA data

Terbutaline Sulfate

Product NDC
0143-9746
11-digit product format
001439746
Labeler code
0143
Product ID
0143-9746_3e8736f7-de5c-4906-851f-6a10a53866ad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Terbutaline Sulfate
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA078630
Marketing category
ANDA
Marketing start
2009-05-20
Substance
TERBUTALINE SULFATE
Active strength
1 mg/mL
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 SULFATE1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii576PU70Y8E
Rxcui857635

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
0143-9746-01Terbutaline Sulfate1 mL in 1 VIALINJECTION19
0143-9746-10Terbutaline Sulfate10 in 1 CARTONINJECTION109

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9746-01ML - Milliliter0143-97466069288e-2c5f-4639-9249-42056ff0322d12018-07-03
0143-9746-10ML - Milliliter0143-9746c8480ad0-fbf9-4a52-98ef-c0b8345c1ec112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TERBUTALINE SULFATEACTIVE INGREDIENT576PU70Y8ETERBUTALINE SULFATE INJECTION [WEST-WARD PHARMACEUTICAL CORP]6
TERBUTALINEACTIVE MOIETYN8ONU3L3PGTERBUTALINE SULFATE INJECTION [WEST-WARD PHARMACEUTICAL CORP]6
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KTERBUTALINE SULFATE INJECTION [WEST-WARD PHARMACEUTICAL CORP]6
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBTERBUTALINE SULFATE INJECTION [WEST-WARD PHARMACEUTICAL CORP]6
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XTERBUTALINE SULFATE INJECTION [WEST-WARD PHARMACEUTICAL CORP]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9746TERBUTALINE SULFATE INJECTION [HIKMA PHARMACEUTICALS USA INC.]9Current NDC, Legacy NDC, 2 package rows20240105_613df3cb-4d55-4d12-ab08-a932481aaa0b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857635terbutaline sulfate 1 MG in 1 ML InjectionPSN613df3cb-4d55-4d12-ab08-a932481aaa0b9
8576351 ML terbutaline sulfate 1 MG/ML InjectionSCD613df3cb-4d55-4d12-ab08-a932481aaa0b9
857635terbutaline sulfate 1 MG per 1 ML InjectionSY613df3cb-4d55-4d12-ab08-a932481aaa0b9
857635terbutaline sulfate 1 MG in 1 ML InjectionPSN6a22b62c-4ee1-49df-e053-2a91aa0a3e524
8576351 ML terbutaline sulfate 1 MG/ML InjectionSCD6a22b62c-4ee1-49df-e053-2a91aa0a3e524
857635terbutaline sulfate 1 MG per 1 ML InjectionSY6a22b62c-4ee1-49df-e053-2a91aa0a3e524

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-9746-01001439746011 mL in 1 VIAL1 mlHistorical
0143-9746-100014397461010 VIAL in 1 CARTON (0143-9746-10) / 1 mL in 1 VIAL (0143-9746-01) 10 vial2009-05-200000-00-00NoNoCurrent