breyna

Generic: budesonide and formoterol fumarate

Labeler: mylan pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name breyna
Generic Name budesonide and formoterol fumarate
Labeler mylan pharmaceuticals inc.
Dosage Form AEROSOL, METERED
Routes
RESPIRATORY (INHALATION)
Active Ingredients

budesonide 160 ug/1, formoterol fumarate 4.5 ug/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-7503
Product ID 0378-7503_23e7ebd2-972d-49f0-95da-7e409da7fcae
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211699
Listing Expiration 2026-12-31
Marketing Start 2023-07-31

Pharmacologic Class

Established (EPC)
corticosteroid [epc]
Mechanism of Action
corticosteroid hormone receptor agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03787503
Hyphenated Format 0378-7503

Supplemental Identifiers

RxCUI
1246288 1246304 2597670 2597673
UNII
Q3OKS62Q6X W34SHF8J2K
NUI
N0000175576 N0000175450

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 breyna (source: ndc)
Generic Name budesonide and formoterol fumarate (source: ndc)
Application Number ANDA211699 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • 160 ug/1
  • 4.5 ug/1
source: ndc
Packaging
  • 1 POUCH in 1 CARTON (0378-7503-32) / 1 CANISTER in 1 POUCH / 120 AEROSOL, METERED in 1 CANISTER
source: ndc

Packages (1)

0378-7503-32 1 POUCH in 1 CARTON (0378-7503-32) / 1 CANISTER in 1 POUCH / 120 AEROSOL, METERED in 1 CANISTER

Ingredients (2)

budesonide (160 ug/1) formoterol fumarate (4.5 ug/1)

Linked Drug Pages (1)

BREYNA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["RESPIRATORY (INHALATION)"], "spl_id": "23e7ebd2-972d-49f0-95da-7e409da7fcae", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["Q3OKS62Q6X", "W34SHF8J2K"], "rxcui": ["1246288", "1246304", "2597670", "2597673"], "spl_set_id": ["dc529fc4-bddb-4673-8202-dc401f86166f"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 POUCH in 1 CARTON (0378-7503-32)  / 1 CANISTER in 1 POUCH / 120 AEROSOL, METERED in 1 CANISTER", "package_ndc": "0378-7503-32", "marketing_start_date": "20230731"}], "brand_name": "BREYNA", "product_id": "0378-7503_23e7ebd2-972d-49f0-95da-7e409da7fcae", "dosage_form": "AEROSOL, METERED", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "0378-7503", "generic_name": "Budesonide and Formoterol Fumarate", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BREYNA", "active_ingredients": [{"name": "BUDESONIDE", "strength": "160 ug/1"}, {"name": "FORMOTEROL FUMARATE", "strength": "4.5 ug/1"}], "application_number": "ANDA211699", "marketing_category": "ANDA", "marketing_start_date": "20230731", "listing_expiration_date": "20261231"}