arformoterol tartrate

Generic: arformoterol tartrate

Labeler: dr. reddy's laboratories, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name arformoterol tartrate
Generic Name arformoterol tartrate
Labeler dr. reddy's laboratories, inc.
Dosage Form SOLUTION
Routes
RESPIRATORY (INHALATION)
Active Ingredients

arformoterol tartrate 15 ug/2mL

Manufacturer
Dr. Reddy's Laboratories, Inc.

Identifiers & Regulatory

Product NDC 43598-777
Product ID 43598-777_a718ab1b-b96b-bed2-24d1-b74c0277daed
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215032
Listing Expiration 2026-12-31
Marketing Start 2024-09-02

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43598777
Hyphenated Format 43598-777

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 ANDA215032 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • 15 ug/2mL
source: ndc
Packaging
  • 30 POUCH in 1 CARTON (43598-777-30) / 1 VIAL, SINGLE-DOSE in 1 POUCH (43598-777-11) / 2 mL in 1 VIAL, SINGLE-DOSE
  • 15 POUCH in 1 CARTON (43598-777-60) / 4 VIAL, SINGLE-DOSE in 1 POUCH (43598-777-48) / 2 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (2)

43598-777-30 30 POUCH in 1 CARTON (43598-777-30) / 1 VIAL, SINGLE-DOSE in 1 POUCH (43598-777-11) / 2 mL in 1 VIAL, SINGLE-DOSE 43598-777-60 15 POUCH in 1 CARTON (43598-777-60) / 4 VIAL, SINGLE-DOSE in 1 POUCH (43598-777-48) / 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": "a718ab1b-b96b-bed2-24d1-b74c0277daed", "openfda": {"unii": ["5P8VJ2I235"], "rxcui": ["668956"], "spl_set_id": ["d8843369-b0d5-6f0d-1fcd-0c49002df755"], "manufacturer_name": ["Dr. Reddy's Laboratories, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 POUCH in 1 CARTON (43598-777-30)  / 1 VIAL, SINGLE-DOSE in 1 POUCH (43598-777-11)  / 2 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "43598-777-30", "marketing_start_date": "20240902"}, {"sample": false, "description": "15 POUCH in 1 CARTON (43598-777-60)  / 4 VIAL, SINGLE-DOSE in 1 POUCH (43598-777-48)  / 2 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "43598-777-60", "marketing_start_date": "20240902"}], "brand_name": "arformoterol tartrate", "product_id": "43598-777_a718ab1b-b96b-bed2-24d1-b74c0277daed", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "43598-777", "generic_name": "arformoterol tartrate", "labeler_name": "Dr. Reddy's Laboratories, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "arformoterol tartrate", "active_ingredients": [{"name": "ARFORMOTEROL TARTRATE", "strength": "15 ug/2mL"}], "application_number": "ANDA215032", "marketing_category": "ANDA", "marketing_start_date": "20240902", "listing_expiration_date": "20261231"}