formoterol fumarate

Generic: formoterol fumarate

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

Drug Facts

Product Profile

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

formoterol fumarate 20 ug/2mL

Manufacturer
Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 70748-261
Product ID 70748-261_7c2eac38-f571-486e-91bb-60f913af5bbc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215053
Listing Expiration 2026-12-31
Marketing Start 2022-11-28

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70748261
Hyphenated Format 70748-261

Supplemental Identifiers

RxCUI
1246319
UPC
0370748261019
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 ANDA215053 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • 20 ug/2mL
source: ndc
Packaging
  • 30 POUCH in 1 CARTON (70748-261-30) / 1 VIAL in 1 POUCH / 2 mL in 1 VIAL
  • 60 POUCH in 1 CARTON (70748-261-60) / 1 VIAL in 1 POUCH / 2 mL in 1 VIAL
source: ndc

Packages (2)

70748-261-30 30 POUCH in 1 CARTON (70748-261-30) / 1 VIAL in 1 POUCH / 2 mL in 1 VIAL 70748-261-60 60 POUCH in 1 CARTON (70748-261-60) / 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": "7c2eac38-f571-486e-91bb-60f913af5bbc", "openfda": {"upc": ["0370748261019"], "unii": ["W34SHF8J2K"], "rxcui": ["1246319"], "spl_set_id": ["44284e8c-0503-48c4-ae71-a0d6b865665d"], "manufacturer_name": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 POUCH in 1 CARTON (70748-261-30)  / 1 VIAL in 1 POUCH / 2 mL in 1 VIAL", "package_ndc": "70748-261-30", "marketing_start_date": "20221128"}, {"sample": false, "description": "60 POUCH in 1 CARTON (70748-261-60)  / 1 VIAL in 1 POUCH / 2 mL in 1 VIAL", "package_ndc": "70748-261-60", "marketing_start_date": "20221128"}], "brand_name": "formoterol fumarate", "product_id": "70748-261_7c2eac38-f571-486e-91bb-60f913af5bbc", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "70748-261", "generic_name": "formoterol fumarate", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "formoterol fumarate", "active_ingredients": [{"name": "FORMOTEROL FUMARATE", "strength": "20 ug/2mL"}], "application_number": "ANDA215053", "marketing_category": "ANDA", "marketing_start_date": "20221128", "listing_expiration_date": "20261231"}