formoterol fumarate

Generic: formoterol fumarate dihydrate

Labeler: mylan pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

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

formoterol fumarate 20 ug/2mL

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-1631
Product ID 0378-1631_db19667d-88cd-47ab-adb5-894959822801
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA022007
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 03781631
Hyphenated Format 0378-1631

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 NDA022007 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • 20 ug/2mL
source: ndc
Packaging
  • 60 POUCH in 1 CARTON (0378-1631-91) / 1 VIAL in 1 POUCH / 2 mL in 1 VIAL
  • 30 POUCH in 1 CARTON (0378-1631-93) / 1 VIAL in 1 POUCH (0378-1631-32) / 2 mL in 1 VIAL
source: ndc

Packages (2)

0378-1631-91 60 POUCH in 1 CARTON (0378-1631-91) / 1 VIAL in 1 POUCH / 2 mL in 1 VIAL 0378-1631-93 30 POUCH in 1 CARTON (0378-1631-93) / 1 VIAL in 1 POUCH (0378-1631-32) / 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": "db19667d-88cd-47ab-adb5-894959822801", "openfda": {"unii": ["W34SHF8J2K"], "rxcui": ["1246319"], "spl_set_id": ["6c1a6c53-af85-4220-9ce3-2373e0928f7f"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 POUCH in 1 CARTON (0378-1631-91)  / 1 VIAL in 1 POUCH / 2 mL in 1 VIAL", "package_ndc": "0378-1631-91", "marketing_start_date": "20210622"}, {"sample": false, "description": "30 POUCH in 1 CARTON (0378-1631-93)  / 1 VIAL in 1 POUCH (0378-1631-32)  / 2 mL in 1 VIAL", "package_ndc": "0378-1631-93", "marketing_start_date": "20210622"}], "brand_name": "FORMOTEROL FUMARATE", "product_id": "0378-1631_db19667d-88cd-47ab-adb5-894959822801", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "0378-1631", "generic_name": "formoterol fumarate dihydrate", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "FORMOTEROL FUMARATE", "active_ingredients": [{"name": "FORMOTEROL FUMARATE", "strength": "20 ug/2mL"}], "application_number": "NDA022007", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20210622", "listing_expiration_date": "20261231"}