bevespi aerosphere

Generic: glycopyrrolate and formoterol fumarate

Labeler: astrazeneca pharmaceuticals lp
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name bevespi aerosphere
Generic Name glycopyrrolate and formoterol fumarate
Labeler astrazeneca pharmaceuticals lp
Dosage Form AEROSOL, METERED
Routes
RESPIRATORY (INHALATION)
Active Ingredients

formoterol fumarate 4.8 ug/1, glycopyrrolate 9 ug/1

Manufacturer
AstraZeneca Pharmaceuticals LP

Identifiers & Regulatory

Product NDC 0310-4600
Product ID 0310-4600_90a24746-75fb-490b-9e0d-7e33a5d8f00a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA208294
Listing Expiration 2026-12-31
Marketing Start 2016-10-03

Pharmacologic Class

Classes
adrenergic beta2-agonists [moa] anticholinergic [epc] cholinergic antagonists [moa] cholinergic muscarinic antagonist [epc] cholinergic muscarinic antagonists [moa] beta2-adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03104600
Hyphenated Format 0310-4600

Supplemental Identifiers

RxCUI
1790639 1790644
UNII
W34SHF8J2K V92SO9WP2I

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 bevespi aerosphere (source: ndc)
Generic Name glycopyrrolate and formoterol fumarate (source: ndc)
Application Number NDA208294 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • 4.8 ug/1
  • 9 ug/1
source: ndc
Packaging
  • 120 AEROSOL, METERED in 1 INHALER (0310-4600-12)
source: ndc

Packages (1)

0310-4600-12 120 AEROSOL, METERED in 1 INHALER (0310-4600-12)

Ingredients (2)

formoterol fumarate (4.8 ug/1) glycopyrrolate (9 ug/1)

Linked Drug Pages (1)

BEVESPI AEROSPHERE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["RESPIRATORY (INHALATION)"], "spl_id": "90a24746-75fb-490b-9e0d-7e33a5d8f00a", "openfda": {"unii": ["W34SHF8J2K", "V92SO9WP2I"], "rxcui": ["1790639", "1790644"], "spl_set_id": ["ae02436e-9528-490e-a844-0c0f6f2843f9"], "manufacturer_name": ["AstraZeneca Pharmaceuticals LP"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 AEROSOL, METERED in 1 INHALER (0310-4600-12)", "package_ndc": "0310-4600-12", "marketing_start_date": "20161003"}], "brand_name": "BEVESPI AEROSPHERE", "product_id": "0310-4600_90a24746-75fb-490b-9e0d-7e33a5d8f00a", "dosage_form": "AEROSOL, METERED", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]", "Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "0310-4600", "generic_name": "Glycopyrrolate and formoterol fumarate", "labeler_name": "AstraZeneca Pharmaceuticals LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BEVESPI AEROSPHERE", "active_ingredients": [{"name": "FORMOTEROL FUMARATE", "strength": "4.8 ug/1"}, {"name": "GLYCOPYRROLATE", "strength": "9 ug/1"}], "application_number": "NDA208294", "marketing_category": "NDA", "marketing_start_date": "20161003", "listing_expiration_date": "20261231"}