formoterol fumarate inhalation solution (76204-030)

Drug Facts

Product Profile

Brand Name formoterol fumarate inhalation solution

Generic Name formoterol fumarate dihydrate

Labeler ritedose pharmaceuticals, llc

Dosage Form SOLUTION

Routes

RESPIRATORY (INHALATION)

Active Ingredients

formoterol fumarate 20 ug/2mL

Manufacturer

Ritedose Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 76204-030

Product ID 76204-030_459f276c-d771-4ae9-e063-6394a90a3476

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA216486

Listing Expiration 2026-12-31

Marketing Start 2025-03-14

Pharmacologic Class

Classes

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76204030

Hyphenated Format 76204-030

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 inhalation solution (source: ndc)

Generic Name formoterol fumarate dihydrate (source: ndc)

Application Number ANDA216486 (source: ndc)

Routes

RESPIRATORY (INHALATION)

source: ndc

Resolved Composition

Strengths

20 ug/2mL

source: ndc

Packaging

30 POUCH in 1 CARTON (76204-030-01) / 1 VIAL in 1 POUCH / 2 mL in 1 VIAL
60 POUCH in 1 CARTON (76204-030-02) / 1 VIAL in 1 POUCH / 2 mL in 1 VIAL

source: ndc

Packages (2)

76204-030-01 30 POUCH in 1 CARTON (76204-030-01) / 1 VIAL in 1 POUCH / 2 mL in 1 VIAL 76204-030-02 60 POUCH in 1 CARTON (76204-030-02) / 1 VIAL in 1 POUCH / 2 mL in 1 VIAL

Ingredients (1)

formoterol fumarate (20 ug/2mL)

Linked Drug Pages (1)

Formoterol Fumarate Inhalation Solution ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["RESPIRATORY (INHALATION)"], "spl_id": "459f276c-d771-4ae9-e063-6394a90a3476", "openfda": {"unii": ["W34SHF8J2K"], "rxcui": ["1246319"], "spl_set_id": ["2d9bf685-8886-4865-834b-2748af124b79"], "manufacturer_name": ["Ritedose Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 POUCH in 1 CARTON (76204-030-01)  / 1 VIAL in 1 POUCH / 2 mL in 1 VIAL", "package_ndc": "76204-030-01", "marketing_start_date": "20250314"}, {"sample": false, "description": "60 POUCH in 1 CARTON (76204-030-02)  / 1 VIAL in 1 POUCH / 2 mL in 1 VIAL", "package_ndc": "76204-030-02", "marketing_start_date": "20250314"}], "brand_name": "Formoterol Fumarate Inhalation Solution", "product_id": "76204-030_459f276c-d771-4ae9-e063-6394a90a3476", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "76204-030", "generic_name": "formoterol fumarate dihydrate", "labeler_name": "Ritedose Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Formoterol Fumarate Inhalation Solution", "active_ingredients": [{"name": "FORMOTEROL FUMARATE", "strength": "20 ug/2mL"}], "application_number": "ANDA216486", "marketing_category": "ANDA", "marketing_start_date": "20250314", "listing_expiration_date": "20261231"}