terbutaline sulfate

Generic: terbutaline sulfate

Labeler: henry schein, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name terbutaline sulfate
Generic Name terbutaline sulfate
Labeler henry schein, inc.
Dosage Form INJECTION
Routes
SUBCUTANEOUS
Active Ingredients

terbutaline sulfate 1 mg/mL

Manufacturer
Henry Schein, Inc.

Identifiers & Regulatory

Product NDC 0404-9778
Product ID 0404-9778_d7e57299-acd7-41cf-9cfb-229cba799be6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078630
Listing Expiration 2026-12-31
Marketing Start 2025-10-07

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04049778
Hyphenated Format 0404-9778

Supplemental Identifiers

RxCUI
857635
UNII
576PU70Y8E

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name terbutaline sulfate (source: ndc)
Generic Name terbutaline sulfate (source: ndc)
Application Number ANDA078630 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 1 VIAL in 1 BAG (0404-9778-01) / 1 mL in 1 VIAL
source: ndc

Packages (1)

0404-9778-01 1 VIAL in 1 BAG (0404-9778-01) / 1 mL in 1 VIAL

Ingredients (1)

terbutaline sulfate (1 mg/mL)

Linked Drug Pages (1)

Terbutaline Sulfate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "d7e57299-acd7-41cf-9cfb-229cba799be6", "openfda": {"unii": ["576PU70Y8E"], "rxcui": ["857635"], "spl_set_id": ["6f8ca215-1844-4bbe-abeb-7a630a144438"], "manufacturer_name": ["Henry Schein, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 BAG (0404-9778-01)  / 1 mL in 1 VIAL", "package_ndc": "0404-9778-01", "marketing_start_date": "20251007"}], "brand_name": "Terbutaline Sulfate", "product_id": "0404-9778_d7e57299-acd7-41cf-9cfb-229cba799be6", "dosage_form": "INJECTION", "product_ndc": "0404-9778", "generic_name": "terbutaline sulfate", "labeler_name": "Henry Schein, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Terbutaline Sulfate", "active_ingredients": [{"name": "TERBUTALINE SULFATE", "strength": "1 mg/mL"}], "application_number": "ANDA078630", "marketing_category": "ANDA", "marketing_start_date": "20251007", "listing_expiration_date": "20261231"}