terbutaline sulfate

Generic: terbutaline sulfate

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name terbutaline sulfate
Generic Name terbutaline sulfate
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

terbutaline sulfate 1 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-665
Product ID 63323-665_15846c75-dc60-4339-b97b-5c9d78d66cf1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076887
Listing Expiration 2026-12-31
Marketing Start 2011-03-10

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323665
Hyphenated Format 63323-665

Supplemental Identifiers

RxCUI
857635
UPC
0363323665005
UNII
576PU70Y8E

Packaging Origin

Original Packager
true

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 ANDA076887 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 25 VIAL, SINGLE-USE in 1 TRAY (63323-665-01) / 1 mL in 1 VIAL, SINGLE-USE (63323-665-00)
source: ndc

Packages (1)

63323-665-01 25 VIAL, SINGLE-USE in 1 TRAY (63323-665-01) / 1 mL in 1 VIAL, SINGLE-USE (63323-665-00)

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": "15846c75-dc60-4339-b97b-5c9d78d66cf1", "openfda": {"upc": ["0363323665005"], "unii": ["576PU70Y8E"], "rxcui": ["857635"], "spl_set_id": ["cec31032-f366-4524-9e01-63146e473b2b"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, SINGLE-USE in 1 TRAY (63323-665-01)  / 1 mL in 1 VIAL, SINGLE-USE (63323-665-00)", "package_ndc": "63323-665-01", "marketing_start_date": "20110310"}], "brand_name": "Terbutaline Sulfate", "product_id": "63323-665_15846c75-dc60-4339-b97b-5c9d78d66cf1", "dosage_form": "INJECTION, SOLUTION", "product_ndc": "63323-665", "generic_name": "TERBUTALINE SULFATE", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Terbutaline Sulfate", "active_ingredients": [{"name": "TERBUTALINE SULFATE", "strength": "1 mg/mL"}], "application_number": "ANDA076887", "marketing_category": "ANDA", "marketing_start_date": "20110310", "listing_expiration_date": "20261231"}