FORMOTEROL FUMARATE

Generic: formoterol fumarate dihydrate

Labeler: Rhodes Pharmaceuticals L.P.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive

Drug Facts

Product Profile

Brand Name FORMOTEROL FUMARATE
Generic Name formoterol fumarate dihydrate
Labeler Rhodes Pharmaceuticals L.P.
Dosage Form SOLUTION
Routes
RESPIRATORY (INHALATION)
Active Ingredients

FORMOTEROL FUMARATE 20 ug/2mL

Identifiers & Regulatory

Product NDC 42858-094
Product ID 42858-094_ee0ec879-43b7-4d16-a3e3-52798132e8c6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215621
Marketing Start 2023-11-15
Marketing End 2026-03-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42858094
Hyphenated Format 42858-094

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 dihydrate (source: ndc)
Application Number ANDA215621 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • 20 ug/2mL
source: ndc
Packaging
  • 30 POUCH in 1 CARTON (42858-094-35) / 1 VIAL in 1 POUCH / 2 mL in 1 VIAL
  • 60 POUCH in 1 CARTON (42858-094-62) / 1 VIAL in 1 POUCH (42858-094-21) / 2 mL in 1 VIAL
source: ndc

Packages (2)

42858-094-35 30 POUCH in 1 CARTON (42858-094-35) / 1 VIAL in 1 POUCH / 2 mL in 1 VIAL 42858-094-62 60 POUCH in 1 CARTON (42858-094-62) / 1 VIAL in 1 POUCH (42858-094-21) / 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": "ee0ec879-43b7-4d16-a3e3-52798132e8c6", "openfda": {"unii": ["W34SHF8J2K"], "rxcui": ["1246319"], "spl_set_id": ["d3aa5d0c-020b-4447-bb02-92f284665840"], "manufacturer_name": ["Rhodes Pharmaceuticals L.P."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 POUCH in 1 CARTON (42858-094-35)  / 1 VIAL in 1 POUCH / 2 mL in 1 VIAL", "package_ndc": "42858-094-35", "marketing_end_date": "20260301", "marketing_start_date": "20231115"}, {"sample": false, "description": "60 POUCH in 1 CARTON (42858-094-62)  / 1 VIAL in 1 POUCH (42858-094-21)  / 2 mL in 1 VIAL", "package_ndc": "42858-094-62", "marketing_end_date": "20260301", "marketing_start_date": "20231115"}], "brand_name": "FORMOTEROL FUMARATE", "product_id": "42858-094_ee0ec879-43b7-4d16-a3e3-52798132e8c6", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "42858-094", "generic_name": "formoterol fumarate dihydrate", "labeler_name": "Rhodes Pharmaceuticals L.P.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "FORMOTEROL FUMARATE", "active_ingredients": [{"name": "FORMOTEROL FUMARATE", "strength": "20 ug/2mL"}], "application_number": "ANDA215621", "marketing_category": "ANDA", "marketing_end_date": "20260301", "marketing_start_date": "20231115"}