arformoterol tartrate

Generic: arformoterol tartrate

Labeler: ingenus pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name arformoterol tartrate
Generic Name arformoterol tartrate
Labeler ingenus pharmaceuticals, llc
Dosage Form SOLUTION
Routes
RESPIRATORY (INHALATION)
Active Ingredients

arformoterol tartrate 15 ug/2mL

Manufacturer
Ingenus Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 50742-395
Product ID 50742-395_36d07bcc-852e-5e20-e063-6394a90aaa7d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218156
Listing Expiration 2026-12-31
Marketing Start 2025-03-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50742395
Hyphenated Format 50742-395

Supplemental Identifiers

RxCUI
668956
UNII
5P8VJ2I235

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 arformoterol tartrate (source: ndc)
Generic Name arformoterol tartrate (source: ndc)
Application Number ANDA218156 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • 15 ug/2mL
source: ndc
Packaging
  • 6 POUCH in 1 CARTON (50742-395-30) / 5 VIAL, SINGLE-DOSE in 1 POUCH / 2 mL in 1 VIAL, SINGLE-DOSE
  • 12 POUCH in 1 CARTON (50742-395-60) / 5 VIAL, SINGLE-DOSE in 1 POUCH (50742-395-05) / 2 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (2)

50742-395-30 6 POUCH in 1 CARTON (50742-395-30) / 5 VIAL, SINGLE-DOSE in 1 POUCH / 2 mL in 1 VIAL, SINGLE-DOSE 50742-395-60 12 POUCH in 1 CARTON (50742-395-60) / 5 VIAL, SINGLE-DOSE in 1 POUCH (50742-395-05) / 2 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

arformoterol tartrate (15 ug/2mL)

Linked Drug Pages (1)

Arformoterol Tartrate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["RESPIRATORY (INHALATION)"], "spl_id": "36d07bcc-852e-5e20-e063-6394a90aaa7d", "openfda": {"unii": ["5P8VJ2I235"], "rxcui": ["668956"], "spl_set_id": ["9572582e-8cc2-4d3d-b9dc-c2b8159d71d8"], "manufacturer_name": ["Ingenus Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 POUCH in 1 CARTON (50742-395-30)  / 5 VIAL, SINGLE-DOSE in 1 POUCH / 2 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "50742-395-30", "marketing_start_date": "20250301"}, {"sample": false, "description": "12 POUCH in 1 CARTON (50742-395-60)  / 5 VIAL, SINGLE-DOSE in 1 POUCH (50742-395-05)  / 2 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "50742-395-60", "marketing_start_date": "20250301"}], "brand_name": "Arformoterol Tartrate", "product_id": "50742-395_36d07bcc-852e-5e20-e063-6394a90aaa7d", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "50742-395", "generic_name": "Arformoterol Tartrate", "labeler_name": "Ingenus Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Arformoterol Tartrate", "active_ingredients": [{"name": "ARFORMOTEROL TARTRATE", "strength": "15 ug/2mL"}], "application_number": "ANDA218156", "marketing_category": "ANDA", "marketing_start_date": "20250301", "listing_expiration_date": "20261231"}