formoterol fumarate

Generic: formoterol fumarate

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name formoterol fumarate
Generic Name formoterol fumarate
Labeler bryant ranch prepack
Dosage Form SOLUTION
Routes
RESPIRATORY (INHALATION)
Active Ingredients

formoterol fumarate 20 ug/2mL

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 63629-8813
Product ID 63629-8813_37f67ff0-5292-47b4-849e-25cf51d1d61b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091141
Listing Expiration 2026-12-31
Marketing Start 2021-06-22

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 636298813
Hyphenated Format 63629-8813

Supplemental Identifiers

RxCUI
1246319
UNII
W34SHF8J2K

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 ANDA091141 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • 20 ug/2mL
source: ndc
Packaging
  • 30 POUCH in 1 CARTON (63629-8813-1) / 1 VIAL in 1 POUCH / 2 mL in 1 VIAL
source: ndc

Packages (1)

63629-8813-1 30 POUCH in 1 CARTON (63629-8813-1) / 1 VIAL in 1 POUCH / 2 mL in 1 VIAL

Ingredients (1)

formoterol fumarate (20 ug/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": "37f67ff0-5292-47b4-849e-25cf51d1d61b", "openfda": {"unii": ["W34SHF8J2K"], "rxcui": ["1246319"], "spl_set_id": ["9786f3e2-4265-4246-9999-f73cd6b33fc8"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "30 POUCH in 1 CARTON (63629-8813-1)  / 1 VIAL in 1 POUCH / 2 mL in 1 VIAL", "package_ndc": "63629-8813-1", "marketing_start_date": "20210910"}], "brand_name": "Formoterol fumarate", "product_id": "63629-8813_37f67ff0-5292-47b4-849e-25cf51d1d61b", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "63629-8813", "generic_name": "Formoterol fumarate", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Formoterol fumarate", "active_ingredients": [{"name": "FORMOTEROL FUMARATE", "strength": "20 ug/2mL"}], "application_number": "ANDA091141", "marketing_category": "ANDA", "marketing_start_date": "20210622", "listing_expiration_date": "20261231"}