formoterol fumarate

Generic: formoterol fumarate

Labeler: micro labs limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name formoterol fumarate
Generic Name formoterol fumarate
Labeler micro labs limited
Dosage Form SOLUTION
Routes
RESPIRATORY (INHALATION)
Active Ingredients

formoterol fumarate 20 ug/2mL

Manufacturer
Micro Labs Limited

Identifiers & Regulatory

Product NDC 42571-463
Product ID 42571-463_22feda0b-260a-8cd2-e063-6394a90af8eb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218304
Listing Expiration 2026-12-31
Marketing Start 2024-10-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42571463
Hyphenated Format 42571-463

Supplemental Identifiers

RxCUI
1246319
UPC
0342571463625 0342571463731
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 (source: ndc)
Generic Name formoterol fumarate (source: ndc)
Application Number ANDA218304 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • 20 ug/2mL
source: ndc
Packaging
  • 60 POUCH in 1 CARTON (42571-463-62) / 1 VIAL in 1 POUCH / 2 mL in 1 VIAL
  • 30 POUCH in 1 CARTON (42571-463-73) / 1 VIAL in 1 POUCH / 2 mL in 1 VIAL
source: ndc

Packages (2)

42571-463-62 60 POUCH in 1 CARTON (42571-463-62) / 1 VIAL in 1 POUCH / 2 mL in 1 VIAL 42571-463-73 30 POUCH in 1 CARTON (42571-463-73) / 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": "22feda0b-260a-8cd2-e063-6394a90af8eb", "openfda": {"upc": ["0342571463625", "0342571463731"], "unii": ["W34SHF8J2K"], "rxcui": ["1246319"], "spl_set_id": ["0796acea-70d6-479f-af48-18723b1efd2a"], "manufacturer_name": ["Micro Labs Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 POUCH in 1 CARTON (42571-463-62)  / 1 VIAL in 1 POUCH / 2 mL in 1 VIAL", "package_ndc": "42571-463-62", "marketing_start_date": "20241001"}, {"sample": false, "description": "30 POUCH in 1 CARTON (42571-463-73)  / 1 VIAL in 1 POUCH / 2 mL in 1 VIAL", "package_ndc": "42571-463-73", "marketing_start_date": "20241001"}], "brand_name": "Formoterol fumarate", "product_id": "42571-463_22feda0b-260a-8cd2-e063-6394a90af8eb", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "42571-463", "generic_name": "Formoterol fumarate", "labeler_name": "Micro Labs Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Formoterol fumarate", "active_ingredients": [{"name": "FORMOTEROL FUMARATE", "strength": "20 ug/2mL"}], "application_number": "ANDA218304", "marketing_category": "ANDA", "marketing_start_date": "20241001", "listing_expiration_date": "20261231"}