Terbutaline Sulfate

Product NDC
0404-9778
11-digit product format
004049778
Labeler code
0404
Product ID
0404-9778_d7e57299-acd7-41cf-9cfb-229cba799be6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
terbutaline sulfate
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Henry Schein, Inc.
Application
ANDA078630
Marketing category
ANDA
Marketing start
2025-10-07
Substance
TERBUTALINE SULFATE
Active strength
1 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
0404-9778-01Terbutaline Sulfate1 in 1 BAGINJECTION11
0404-9778-01Terbutaline Sulfate1 mL in 1 VIALINJECTION11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0404-9778-01004049778011 VIAL in 1 BAG (0404-9778-01) / 1 mL in 1 VIAL1 vial2025-10-07NoNoHistorical