arformoterol tartrate inhalation solution (76204-026)

Drug Facts

Product Profile

Brand Name arformoterol tartrate inhalation solution

Generic Name arformoterol tartrate inhalation solution

Labeler ritedose pharmaceuticals, llc

Dosage Form SOLUTION

Routes

RESPIRATORY (INHALATION)

Active Ingredients

arformoterol tartrate 15 ug/2mL

Manufacturer

Ritedose Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 76204-026

Product ID 76204-026_459f97a4-5026-29d1-e063-6294a90a1a9a

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA214736

Listing Expiration 2026-12-31

Marketing Start 2023-02-27

Pharmacologic Class

Classes

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76204026

Hyphenated Format 76204-026

Supplemental Identifiers

RxCUI

668956

UPC

0376204026024 0376204026017

UNII

5P8VJ2I235

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 arformoterol tartrate inhalation solution (source: ndc)

Generic Name arformoterol tartrate inhalation solution (source: ndc)

Application Number ANDA214736 (source: ndc)

Routes

RESPIRATORY (INHALATION)

source: ndc

Resolved Composition

Strengths

15 ug/2mL

source: ndc

Packaging

30 POUCH in 1 CARTON (76204-026-01) / 1 AMPULE in 1 POUCH / 2 mL in 1 AMPULE
60 POUCH in 1 CARTON (76204-026-02) / 1 AMPULE in 1 POUCH / 2 mL in 1 AMPULE
12 POUCH in 1 CARTON (76204-026-55) / 5 AMPULE in 1 POUCH / 2 mL in 1 AMPULE

source: ndc

Packages (3)

76204-026-01 30 POUCH in 1 CARTON (76204-026-01) / 1 AMPULE in 1 POUCH / 2 mL in 1 AMPULE 76204-026-02 60 POUCH in 1 CARTON (76204-026-02) / 1 AMPULE in 1 POUCH / 2 mL in 1 AMPULE 76204-026-55 12 POUCH in 1 CARTON (76204-026-55) / 5 AMPULE in 1 POUCH / 2 mL in 1 AMPULE

Ingredients (1)

arformoterol tartrate (15 ug/2mL)

Linked Drug Pages (1)

Arformoterol Tartrate Inhalation Solution ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["RESPIRATORY (INHALATION)"], "spl_id": "459f97a4-5026-29d1-e063-6294a90a1a9a", "openfda": {"upc": ["0376204026024", "0376204026017"], "unii": ["5P8VJ2I235"], "rxcui": ["668956"], "spl_set_id": ["ef524b4c-68d7-c464-e053-2a95a90a7f96"], "manufacturer_name": ["Ritedose Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 POUCH in 1 CARTON (76204-026-01)  / 1 AMPULE in 1 POUCH / 2 mL in 1 AMPULE", "package_ndc": "76204-026-01", "marketing_start_date": "20230227"}, {"sample": false, "description": "60 POUCH in 1 CARTON (76204-026-02)  / 1 AMPULE in 1 POUCH / 2 mL in 1 AMPULE", "package_ndc": "76204-026-02", "marketing_start_date": "20230227"}, {"sample": false, "description": "12 POUCH in 1 CARTON (76204-026-55)  / 5 AMPULE in 1 POUCH / 2 mL in 1 AMPULE", "package_ndc": "76204-026-55", "marketing_start_date": "20230227"}], "brand_name": "Arformoterol Tartrate Inhalation Solution", "product_id": "76204-026_459f97a4-5026-29d1-e063-6294a90a1a9a", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "76204-026", "generic_name": "Arformoterol Tartrate Inhalation Solution", "labeler_name": "Ritedose Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Arformoterol Tartrate Inhalation Solution", "active_ingredients": [{"name": "ARFORMOTEROL TARTRATE", "strength": "15 ug/2mL"}], "application_number": "ANDA214736", "marketing_category": "ANDA", "marketing_start_date": "20230227", "listing_expiration_date": "20261231"}