formoterol fumarate

Generic: formoterol fumarate

Labeler: alembic pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

formoterol fumarate 20 ug/2mL

Manufacturer
Alembic Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 62332-655
Product ID 62332-655_99e63a2d-5d11-43b4-ba83-1d64f3fc3914
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215078
Listing Expiration 2026-12-31
Marketing Start 2021-11-22

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62332655
Hyphenated Format 62332-655

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 (source: ndc)
Application Number ANDA215078 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • 20 ug/2mL
source: ndc
Packaging
  • 30 POUCH in 1 CARTON (62332-655-30) / 1 VIAL in 1 POUCH (62332-655-01) / 2 mL in 1 VIAL
  • 60 POUCH in 1 CARTON (62332-655-60) / 1 VIAL in 1 POUCH / 2 mL in 1 VIAL
source: ndc

Packages (2)

62332-655-30 30 POUCH in 1 CARTON (62332-655-30) / 1 VIAL in 1 POUCH (62332-655-01) / 2 mL in 1 VIAL 62332-655-60 60 POUCH in 1 CARTON (62332-655-60) / 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": "99e63a2d-5d11-43b4-ba83-1d64f3fc3914", "openfda": {"unii": ["W34SHF8J2K"], "rxcui": ["1246319"], "spl_set_id": ["07afdf7e-c480-4806-b469-a6a460522bc0"], "manufacturer_name": ["Alembic Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 POUCH in 1 CARTON (62332-655-30)  / 1 VIAL in 1 POUCH (62332-655-01)  / 2 mL in 1 VIAL", "package_ndc": "62332-655-30", "marketing_start_date": "20211122"}, {"sample": false, "description": "60 POUCH in 1 CARTON (62332-655-60)  / 1 VIAL in 1 POUCH / 2 mL in 1 VIAL", "package_ndc": "62332-655-60", "marketing_start_date": "20211122"}], "brand_name": "Formoterol Fumarate", "product_id": "62332-655_99e63a2d-5d11-43b4-ba83-1d64f3fc3914", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "62332-655", "generic_name": "Formoterol Fumarate", "labeler_name": "Alembic Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Formoterol Fumarate", "active_ingredients": [{"name": "FORMOTEROL FUMARATE", "strength": "20 ug/2mL"}], "application_number": "ANDA215078", "marketing_category": "ANDA", "marketing_start_date": "20211122", "listing_expiration_date": "20261231"}