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 .83 mg/mL

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-858
Product ID 65862-858_235055b3-2ceb-89e9-e063-6394a90aee19
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206224
Listing Expiration 2026-12-31
Marketing Start 2017-10-17

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65862858
Hyphenated Format 65862-858

Supplemental Identifiers

RxCUI
630208
UPC
0365862858054
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 ANDA206224 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • .83 mg/mL
source: ndc
Packaging
  • 30 POUCH in 1 CARTON (65862-858-03) / 1 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE
  • 5 POUCH in 1 CARTON (65862-858-25) / 5 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE
  • 6 POUCH in 1 CARTON (65862-858-30) / 5 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE
  • 12 POUCH in 1 CARTON (65862-858-60) / 5 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (4)

65862-858-03 30 POUCH in 1 CARTON (65862-858-03) / 1 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE 65862-858-25 5 POUCH in 1 CARTON (65862-858-25) / 5 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE 65862-858-30 6 POUCH in 1 CARTON (65862-858-30) / 5 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE 65862-858-60 12 POUCH in 1 CARTON (65862-858-60) / 5 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

albuterol sulfate (.83 mg/mL)

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": "235055b3-2ceb-89e9-e063-6394a90aee19", "openfda": {"upc": ["0365862858054"], "unii": ["021SEF3731"], "rxcui": ["630208"], "spl_set_id": ["eafa5b05-d692-48e7-a413-30f847547eb2"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 POUCH in 1 CARTON (65862-858-03)  / 1 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "65862-858-03", "marketing_start_date": "20171017"}, {"sample": false, "description": "5 POUCH in 1 CARTON (65862-858-25)  / 5 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "65862-858-25", "marketing_start_date": "20171017"}, {"sample": false, "description": "6 POUCH in 1 CARTON (65862-858-30)  / 5 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "65862-858-30", "marketing_start_date": "20171017"}, {"sample": false, "description": "12 POUCH in 1 CARTON (65862-858-60)  / 5 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "65862-858-60", "marketing_start_date": "20171017"}], "brand_name": "ALBUTEROL SULFATE", "product_id": "65862-858_235055b3-2ceb-89e9-e063-6394a90aee19", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "65862-858", "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": ".83 mg/mL"}], "application_number": "ANDA206224", "marketing_category": "ANDA", "marketing_start_date": "20171017", "listing_expiration_date": "20261231"}