albuterol sulfate

Generic: albuterol sulfate

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name albuterol sulfate
Generic Name albuterol sulfate
Labeler aurobindo pharma limited
Dosage Form SOLUTION
Routes
RESPIRATORY (INHALATION)
Active Ingredients

albuterol sulfate 1.25 mg/3mL

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-184
Product ID 59651-184_1e853c87-b534-65d2-e063-6394a90a7923
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211888
Listing Expiration 2026-12-31
Marketing Start 2020-04-20

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59651184
Hyphenated Format 59651-184

Supplemental Identifiers

RxCUI
351136 351137
UPC
0359651183052 0359651184059
UNII
021SEF3731

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 albuterol sulfate (source: ndc)
Generic Name albuterol sulfate (source: ndc)
Application Number ANDA211888 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • 1.25 mg/3mL
source: ndc
Packaging
  • 5 POUCH in 1 CARTON (59651-184-25) / 5 VIAL in 1 POUCH / 3 mL in 1 VIAL
  • 6 POUCH in 1 CARTON (59651-184-30) / 5 VIAL in 1 POUCH / 3 mL in 1 VIAL
source: ndc

Packages (2)

59651-184-25 5 POUCH in 1 CARTON (59651-184-25) / 5 VIAL in 1 POUCH / 3 mL in 1 VIAL 59651-184-30 6 POUCH in 1 CARTON (59651-184-30) / 5 VIAL in 1 POUCH / 3 mL in 1 VIAL

Ingredients (1)

albuterol sulfate (1.25 mg/3mL)

Linked Drug Pages (1)

ALBUTEROL SULFATE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["RESPIRATORY (INHALATION)"], "spl_id": "1e853c87-b534-65d2-e063-6394a90a7923", "openfda": {"upc": ["0359651183052", "0359651184059"], "unii": ["021SEF3731"], "rxcui": ["351136", "351137"], "spl_set_id": ["78e6bee2-7113-46cf-8c97-dc61b0f7b94f"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 POUCH in 1 CARTON (59651-184-25)  / 5 VIAL in 1 POUCH / 3 mL in 1 VIAL", "package_ndc": "59651-184-25", "marketing_start_date": "20200420"}, {"sample": false, "description": "6 POUCH in 1 CARTON (59651-184-30)  / 5 VIAL in 1 POUCH / 3 mL in 1 VIAL", "package_ndc": "59651-184-30", "marketing_start_date": "20240729"}], "brand_name": "ALBUTEROL SULFATE", "product_id": "59651-184_1e853c87-b534-65d2-e063-6394a90a7923", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "59651-184", "generic_name": "ALBUTEROL SULFATE", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ALBUTEROL SULFATE", "active_ingredients": [{"name": "ALBUTEROL SULFATE", "strength": "1.25 mg/3mL"}], "application_number": "ANDA211888", "marketing_category": "ANDA", "marketing_start_date": "20200420", "listing_expiration_date": "20261231"}