formoterol fumarate

Generic: formoterol fumarate dihydrate

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name formoterol fumarate
Generic Name formoterol fumarate dihydrate
Labeler major pharmaceuticals
Dosage Form SOLUTION
Routes
RESPIRATORY (INHALATION)
Active Ingredients

formoterol fumarate 20 ug/2mL

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-7454
Product ID 0904-7454_3d17ee3c-6f45-4127-b92d-41520c9d5b6b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215883
Listing Expiration 2026-12-31
Marketing Start 2024-11-11

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 09047454
Hyphenated Format 0904-7454

Supplemental Identifiers

RxCUI
1246319
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 dihydrate (source: ndc)
Application Number ANDA215883 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • 20 ug/2mL
source: ndc
Packaging
  • 30 POUCH in 1 CARTON (0904-7454-11) / 1 VIAL in 1 POUCH (0904-7454-98) / 2 mL in 1 VIAL
  • 60 POUCH in 1 CARTON (0904-7454-14) / 4 VIAL in 1 POUCH (0904-7454-55) / 2 mL in 1 VIAL
source: ndc

Packages (2)

0904-7454-11 30 POUCH in 1 CARTON (0904-7454-11) / 1 VIAL in 1 POUCH (0904-7454-98) / 2 mL in 1 VIAL 0904-7454-14 60 POUCH in 1 CARTON (0904-7454-14) / 4 VIAL in 1 POUCH (0904-7454-55) / 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": "3d17ee3c-6f45-4127-b92d-41520c9d5b6b", "openfda": {"unii": ["W34SHF8J2K"], "rxcui": ["1246319"], "spl_set_id": ["c77e5f67-01bc-4704-8120-0e2e3d020482"], "manufacturer_name": ["Major Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 POUCH in 1 CARTON (0904-7454-11)  / 1 VIAL in 1 POUCH (0904-7454-98)  / 2 mL in 1 VIAL", "package_ndc": "0904-7454-11", "marketing_start_date": "20241111"}, {"sample": false, "description": "60 POUCH in 1 CARTON (0904-7454-14)  / 4 VIAL in 1 POUCH (0904-7454-55)  / 2 mL in 1 VIAL", "package_ndc": "0904-7454-14", "marketing_start_date": "20241111"}], "brand_name": "Formoterol fumarate", "product_id": "0904-7454_3d17ee3c-6f45-4127-b92d-41520c9d5b6b", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "0904-7454", "generic_name": "Formoterol fumarate dihydrate", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Formoterol fumarate", "active_ingredients": [{"name": "FORMOTEROL FUMARATE", "strength": "20 ug/2mL"}], "application_number": "ANDA215883", "marketing_category": "ANDA", "marketing_start_date": "20241111", "listing_expiration_date": "20261231"}