albuterol sulfate

Generic: albuterol sulfate

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name albuterol sulfate
Generic Name albuterol sulfate
Labeler sun pharmaceutical industries, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

albuterol sulfate 4 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 53489-177
Product ID 53489-177_32bc49e5-840e-4965-8e64-4b1945f9963c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA072637
Listing Expiration 2026-12-31
Marketing Start 1989-12-05

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 53489177
Hyphenated Format 53489-177

Supplemental Identifiers

RxCUI
197316 197318
UPC
0353489177016
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 ANDA072637 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (53489-177-01)
  • 50 TABLET in 1 BOTTLE (53489-177-02)
  • 250 TABLET in 1 BOTTLE (53489-177-03)
  • 500 TABLET in 1 BOTTLE (53489-177-05)
  • 1000 TABLET in 1 BOTTLE (53489-177-10)
source: ndc

Packages (5)

53489-177-01 100 TABLET in 1 BOTTLE (53489-177-01) 53489-177-02 50 TABLET in 1 BOTTLE (53489-177-02) 53489-177-03 250 TABLET in 1 BOTTLE (53489-177-03) 53489-177-05 500 TABLET in 1 BOTTLE (53489-177-05) 53489-177-10 1000 TABLET in 1 BOTTLE (53489-177-10)

Ingredients (1)

albuterol sulfate (4 mg/1)

Linked Drug Pages (1)

albuterol sulfate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "32bc49e5-840e-4965-8e64-4b1945f9963c", "openfda": {"upc": ["0353489177016"], "unii": ["021SEF3731"], "rxcui": ["197316", "197318"], "spl_set_id": ["87b8cd3c-2849-4b50-b63e-9ea379165c07"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (53489-177-01)", "package_ndc": "53489-177-01", "marketing_start_date": "19891205"}, {"sample": false, "description": "50 TABLET in 1 BOTTLE (53489-177-02)", "package_ndc": "53489-177-02", "marketing_start_date": "19891205"}, {"sample": false, "description": "250 TABLET in 1 BOTTLE (53489-177-03)", "package_ndc": "53489-177-03", "marketing_start_date": "19891205"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (53489-177-05)", "package_ndc": "53489-177-05", "marketing_start_date": "19891205"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (53489-177-10)", "package_ndc": "53489-177-10", "marketing_start_date": "19891205"}], "brand_name": "albuterol sulfate", "product_id": "53489-177_32bc49e5-840e-4965-8e64-4b1945f9963c", "dosage_form": "TABLET", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "53489-177", "generic_name": "albuterol sulfate", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "albuterol sulfate", "active_ingredients": [{"name": "ALBUTEROL SULFATE", "strength": "4 mg/1"}], "application_number": "ANDA072637", "marketing_category": "ANDA", "marketing_start_date": "19891205", "listing_expiration_date": "20261231"}