formoterol fumarate (50742-394)

Drug Facts

Product Profile

Brand Name formoterol fumarate

Generic Name formoterol fumarate

Labeler ingenus pharmaceuticals, llc

Dosage Form SOLUTION

Routes

RESPIRATORY (INHALATION)

Active Ingredients

formoterol fumarate .02 mg/2mL

Manufacturer

Ingenus Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 50742-394

Product ID 50742-394_36df181b-7f3a-3ad2-e063-6294a90ab756

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA216426

Listing Expiration 2026-12-31

Marketing Start 2025-06-05

Pharmacologic Class

Classes

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50742394

Hyphenated Format 50742-394

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 ANDA216426 (source: ndc)

Routes

RESPIRATORY (INHALATION)

source: ndc

Resolved Composition

Strengths

.02 mg/2mL

source: ndc

Packaging

30 POUCH in 1 CARTON (50742-394-30) / 1 VIAL, SINGLE-DOSE in 1 POUCH (50742-394-01) / 2 mL in 1 VIAL, SINGLE-DOSE
60 POUCH in 1 CARTON (50742-394-60) / 1 VIAL, SINGLE-DOSE in 1 POUCH / 2 mL in 1 VIAL, SINGLE-DOSE

source: ndc

Packages (2)

50742-394-30 30 POUCH in 1 CARTON (50742-394-30) / 1 VIAL, SINGLE-DOSE in 1 POUCH (50742-394-01) / 2 mL in 1 VIAL, SINGLE-DOSE 50742-394-60 60 POUCH in 1 CARTON (50742-394-60) / 1 VIAL, SINGLE-DOSE in 1 POUCH / 2 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

formoterol fumarate (.02 mg/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": "36df181b-7f3a-3ad2-e063-6294a90ab756", "openfda": {"unii": ["W34SHF8J2K"], "rxcui": ["1246319"], "spl_set_id": ["303479a7-80fb-1f6d-e063-6394a90abbda"], "manufacturer_name": ["Ingenus Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 POUCH in 1 CARTON (50742-394-30)  / 1 VIAL, SINGLE-DOSE in 1 POUCH (50742-394-01)  / 2 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "50742-394-30", "marketing_start_date": "20250606"}, {"sample": false, "description": "60 POUCH in 1 CARTON (50742-394-60)  / 1 VIAL, SINGLE-DOSE in 1 POUCH / 2 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "50742-394-60", "marketing_start_date": "20250605"}], "brand_name": "Formoterol Fumarate", "product_id": "50742-394_36df181b-7f3a-3ad2-e063-6294a90ab756", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "50742-394", "generic_name": "Formoterol Fumarate", "labeler_name": "Ingenus Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Formoterol Fumarate", "active_ingredients": [{"name": "FORMOTEROL FUMARATE", "strength": ".02 mg/2mL"}], "application_number": "ANDA216426", "marketing_category": "ANDA", "marketing_start_date": "20250605", "listing_expiration_date": "20261231"}