terbutaline sulfate

Generic: terbutaline sulfate

Labeler: amneal pharmaceuticals of new york llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name terbutaline sulfate
Generic Name terbutaline sulfate
Labeler amneal pharmaceuticals of new york llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

terbutaline sulfate 5 mg/1

Manufacturer
Amneal Pharmaceuticals of New York LLC

Identifiers & Regulatory

Product NDC 0115-2622
Product ID 0115-2622_63142944-3083-4d47-908f-2984144b6c5d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075877
Listing Expiration 2026-12-31
Marketing Start 2001-06-26

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01152622
Hyphenated Format 0115-2622

Supplemental Identifiers

RxCUI
857677 857683
UPC
0301152622011 0301152611015
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 ANDA075877 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (0115-2622-01)
  • 500 TABLET in 1 BOTTLE (0115-2622-02)
source: ndc

Packages (2)

0115-2622-01 100 TABLET in 1 BOTTLE (0115-2622-01) 0115-2622-02 500 TABLET in 1 BOTTLE (0115-2622-02)

Ingredients (1)

terbutaline sulfate (5 mg/1)

Linked Drug Pages (1)

TERBUTALINE SULFATE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "63142944-3083-4d47-908f-2984144b6c5d", "openfda": {"upc": ["0301152622011", "0301152611015"], "unii": ["576PU70Y8E"], "rxcui": ["857677", "857683"], "spl_set_id": ["382dcebb-6e41-4335-818d-b5822e3fb884"], "manufacturer_name": ["Amneal Pharmaceuticals of New York LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (0115-2622-01)", "package_ndc": "0115-2622-01", "marketing_start_date": "20010626"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (0115-2622-02)", "package_ndc": "0115-2622-02", "marketing_start_date": "20010626"}], "brand_name": "TERBUTALINE SULFATE", "product_id": "0115-2622_63142944-3083-4d47-908f-2984144b6c5d", "dosage_form": "TABLET", "product_ndc": "0115-2622", "generic_name": "TERBUTALINE SULFATE", "labeler_name": "Amneal Pharmaceuticals of New York LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TERBUTALINE SULFATE", "active_ingredients": [{"name": "TERBUTALINE SULFATE", "strength": "5 mg/1"}], "application_number": "ANDA075877", "marketing_category": "ANDA", "marketing_start_date": "20010626", "listing_expiration_date": "20261231"}