Terbutaline Sulfate

Product NDC
0404-9962
11-digit product format
004049962
Labeler code
0404
Product ID
0404-9962_71e41b5f-46c2-4c2d-8f63-e164903d16f6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Terbutaline Sulfate
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Henry Schein, Inc.
Application
ANDA076887
Marketing category
ANDA
Marketing start
2022-01-12
Marketing end
2027-03-01
Substance
TERBUTALINE SULFATE
Active strength
1 mg/mL
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Terbutaline Sulfate

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
0404-9962-01Terbutaline Sulfate1 mL in 1 VIALINJECTION, SOLUTION16
0404-9962-01Terbutaline Sulfate1 in 1 BAGINJECTION, SOLUTION16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0404-9962TERBUTALINE SULFATE INJECTION, SOLUTION [HENRY SCHEIN, INC.]5Current NDC, Legacy NDC, 2 package rows20241018_9f4b177e-4d7d-4255-afeb-522c7d4594c6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857635terbutaline sulfate 1 MG in 1 ML InjectionPSN9f4b177e-4d7d-4255-afeb-522c7d4594c66
8576351 ML terbutaline sulfate 1 MG/ML InjectionSCD9f4b177e-4d7d-4255-afeb-522c7d4594c66
857635terbutaline sulfate 1 MG per 1 ML InjectionSY9f4b177e-4d7d-4255-afeb-522c7d4594c66

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0404-9962-01004049962011 VIAL in 1 BAG (0404-9962-01) / 1 mL in 1 VIAL1 vial2022-01-122027-03-01NoNoCurrent