albuterol

Generic: albuterol

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

Drug Facts

Product Profile

Brand Name albuterol
Generic Name albuterol
Labeler aurobindo pharma limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

albuterol sulfate 2 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-333
Product ID 59651-333_f89dffb1-5c4b-48aa-90b4-74043fc9b690
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213657
Listing Expiration 2026-12-31
Marketing Start 2020-05-14

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59651333
Hyphenated Format 59651-333

Supplemental Identifiers

RxCUI
197316 197318
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 (source: ndc)
Generic Name albuterol (source: ndc)
Application Number ANDA213657 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (59651-333-01)
  • 500 TABLET in 1 BOTTLE (59651-333-05)
source: ndc

Packages (2)

59651-333-01 100 TABLET in 1 BOTTLE (59651-333-01) 59651-333-05 500 TABLET in 1 BOTTLE (59651-333-05)

Ingredients (1)

albuterol sulfate (2 mg/1)

Linked Drug Pages (1)

Albuterol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "f89dffb1-5c4b-48aa-90b4-74043fc9b690", "openfda": {"unii": ["021SEF3731"], "rxcui": ["197316", "197318"], "spl_set_id": ["ff9b287b-e4a4-4c12-ad2f-6b7d55b20dc6"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (59651-333-01)", "package_ndc": "59651-333-01", "marketing_start_date": "20200514"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (59651-333-05)", "package_ndc": "59651-333-05", "marketing_start_date": "20200514"}], "brand_name": "Albuterol", "product_id": "59651-333_f89dffb1-5c4b-48aa-90b4-74043fc9b690", "dosage_form": "TABLET", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "59651-333", "generic_name": "Albuterol", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Albuterol", "active_ingredients": [{"name": "ALBUTEROL SULFATE", "strength": "2 mg/1"}], "application_number": "ANDA213657", "marketing_category": "ANDA", "marketing_start_date": "20200514", "listing_expiration_date": "20261231"}