arformoterol tartrate

Generic: arformoterol tartrate

Labeler: cipla usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name arformoterol tartrate
Generic Name arformoterol tartrate
Labeler cipla usa inc.
Dosage Form SOLUTION
Routes
RESPIRATORY (INHALATION)
Active Ingredients

arformoterol tartrate 15 ug/2mL

Manufacturer
Cipla USA Inc.

Identifiers & Regulatory

Product NDC 69097-168
Product ID 69097-168_07b162cc-b71c-4750-a10b-2db80625012f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207306
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 69097168
Hyphenated Format 69097-168

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 ANDA207306 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • 15 ug/2mL
source: ndc
Packaging
  • 30 POUCH in 1 CARTON (69097-168-53) / 1 VIAL, SINGLE-DOSE in 1 POUCH (69097-168-32) / 2 mL in 1 VIAL, SINGLE-DOSE
  • 12 POUCH in 1 CARTON (69097-168-64) / 5 VIAL, SINGLE-DOSE in 1 POUCH / 2 mL in 1 VIAL, SINGLE-DOSE
  • 6 POUCH in 1 CARTON (69097-168-87) / 5 VIAL, SINGLE-DOSE in 1 POUCH (69097-168-48) / 2 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (3)

69097-168-53 30 POUCH in 1 CARTON (69097-168-53) / 1 VIAL, SINGLE-DOSE in 1 POUCH (69097-168-32) / 2 mL in 1 VIAL, SINGLE-DOSE 69097-168-64 12 POUCH in 1 CARTON (69097-168-64) / 5 VIAL, SINGLE-DOSE in 1 POUCH / 2 mL in 1 VIAL, SINGLE-DOSE 69097-168-87 6 POUCH in 1 CARTON (69097-168-87) / 5 VIAL, SINGLE-DOSE in 1 POUCH (69097-168-48) / 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": "07b162cc-b71c-4750-a10b-2db80625012f", "openfda": {"unii": ["5P8VJ2I235"], "rxcui": ["668956"], "spl_set_id": ["70071afd-5323-4019-aca5-5534278829dc"], "manufacturer_name": ["Cipla USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 POUCH in 1 CARTON (69097-168-53)  / 1 VIAL, SINGLE-DOSE in 1 POUCH (69097-168-32)  / 2 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "69097-168-53", "marketing_start_date": "20220127"}, {"sample": false, "description": "12 POUCH in 1 CARTON (69097-168-64)  / 5 VIAL, SINGLE-DOSE in 1 POUCH / 2 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "69097-168-64", "marketing_start_date": "20210622"}, {"sample": false, "description": "6 POUCH in 1 CARTON (69097-168-87)  / 5 VIAL, SINGLE-DOSE in 1 POUCH (69097-168-48)  / 2 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "69097-168-87", "marketing_start_date": "20210622"}], "brand_name": "arformoterol tartrate", "product_id": "69097-168_07b162cc-b71c-4750-a10b-2db80625012f", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "69097-168", "generic_name": "arformoterol tartrate", "labeler_name": "Cipla USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "arformoterol tartrate", "active_ingredients": [{"name": "ARFORMOTEROL TARTRATE", "strength": "15 ug/2mL"}], "application_number": "ANDA207306", "marketing_category": "ANDA", "marketing_start_date": "20210622", "listing_expiration_date": "20261231"}