terbutaline sulfate

Generic: terbutaline sulfate

Labeler: lannett company, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name terbutaline sulfate
Generic Name terbutaline sulfate
Labeler lannett company, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

terbutaline sulfate 5 mg/1

Manufacturer
Lannett Company, Inc.

Identifiers & Regulatory

Product NDC 0527-1311
Product ID 0527-1311_75d6b891-2c50-4748-829a-3567ee966978
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077152
Listing Expiration 2026-12-31
Marketing Start 2005-03-25

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05271311
Hyphenated Format 0527-1311

Supplemental Identifiers

RxCUI
857677 857683
UPC
0305271318015
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 ANDA077152 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (0527-1311-01)
  • 1000 TABLET in 1 BOTTLE (0527-1311-10)
source: ndc

Packages (2)

0527-1311-01 100 TABLET in 1 BOTTLE (0527-1311-01) 0527-1311-10 1000 TABLET in 1 BOTTLE (0527-1311-10)

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": "75d6b891-2c50-4748-829a-3567ee966978", "openfda": {"upc": ["0305271318015"], "unii": ["576PU70Y8E"], "rxcui": ["857677", "857683"], "spl_set_id": ["fbf54709-5857-4dbc-9233-ebd7abff88c8"], "manufacturer_name": ["Lannett Company, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (0527-1311-01)", "package_ndc": "0527-1311-01", "marketing_start_date": "20050325"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (0527-1311-10)", "package_ndc": "0527-1311-10", "marketing_start_date": "20050325"}], "brand_name": "Terbutaline Sulfate", "product_id": "0527-1311_75d6b891-2c50-4748-829a-3567ee966978", "dosage_form": "TABLET", "product_ndc": "0527-1311", "generic_name": "Terbutaline Sulfate", "labeler_name": "Lannett Company, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Terbutaline Sulfate", "active_ingredients": [{"name": "TERBUTALINE SULFATE", "strength": "5 mg/1"}], "application_number": "ANDA077152", "marketing_category": "ANDA", "marketing_start_date": "20050325", "listing_expiration_date": "20261231"}