formoterol fumarate

Generic: formoterol fumarate

Labeler: teva pharmaceuticals usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name formoterol fumarate
Generic Name formoterol fumarate
Labeler teva pharmaceuticals usa, inc.
Dosage Form SOLUTION
Routes
RESPIRATORY (INHALATION)
Active Ingredients

formoterol fumarate 20 ug/2mL

Manufacturer
Teva Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 0093-4061
Product ID 0093-4061_0ecd7fc0-7e29-4502-91ff-a0ead5a5a1f8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091141
Listing Expiration 2026-12-31
Marketing Start 2021-06-22

Pharmacologic Class

Classes
adrenergic beta2-agonists [moa] beta2-adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00934061
Hyphenated Format 0093-4061

Supplemental Identifiers

RxCUI
1246319
UNII
W34SHF8J2K

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 formoterol fumarate (source: ndc)
Generic Name formoterol fumarate (source: ndc)
Application Number ANDA091141 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • 20 ug/2mL
source: ndc
Packaging
  • 60 POUCH in 1 CARTON (0093-4061-06) / 1 VIAL in 1 POUCH / 2 mL in 1 VIAL
  • 30 POUCH in 1 CARTON (0093-4061-30) / 1 VIAL in 1 POUCH (0093-4061-19) / 2 mL in 1 VIAL
source: ndc

Packages (2)

0093-4061-06 60 POUCH in 1 CARTON (0093-4061-06) / 1 VIAL in 1 POUCH / 2 mL in 1 VIAL 0093-4061-30 30 POUCH in 1 CARTON (0093-4061-30) / 1 VIAL in 1 POUCH (0093-4061-19) / 2 mL in 1 VIAL

Ingredients (1)

formoterol fumarate (20 ug/2mL)

Linked Drug Pages (1)

Formoterol fumarate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["RESPIRATORY (INHALATION)"], "spl_id": "0ecd7fc0-7e29-4502-91ff-a0ead5a5a1f8", "openfda": {"unii": ["W34SHF8J2K"], "rxcui": ["1246319"], "spl_set_id": ["419bc85d-8e24-478b-921e-babfb73e79f3"], "manufacturer_name": ["Teva Pharmaceuticals USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 POUCH in 1 CARTON (0093-4061-06)  / 1 VIAL in 1 POUCH / 2 mL in 1 VIAL", "package_ndc": "0093-4061-06", "marketing_start_date": "20210622"}, {"sample": false, "description": "30 POUCH in 1 CARTON (0093-4061-30)  / 1 VIAL in 1 POUCH (0093-4061-19)  / 2 mL in 1 VIAL", "package_ndc": "0093-4061-30", "marketing_start_date": "20210622"}], "brand_name": "Formoterol fumarate", "product_id": "0093-4061_0ecd7fc0-7e29-4502-91ff-a0ead5a5a1f8", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "0093-4061", "generic_name": "Formoterol fumarate", "labeler_name": "Teva Pharmaceuticals USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Formoterol fumarate", "active_ingredients": [{"name": "FORMOTEROL FUMARATE", "strength": "20 ug/2mL"}], "application_number": "ANDA091141", "marketing_category": "ANDA", "marketing_start_date": "20210622", "listing_expiration_date": "20261231"}