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 SOLUTION
Routes
RESPIRATORY (INHALATION)
Active Ingredients

albuterol sulfate .83 mg/mL

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 47335-703
Product ID 47335-703_2833984c-f479-4e90-b947-80df3d3111f7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207857
Listing Expiration 2026-12-31
Marketing Start 2021-06-11

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 47335703
Hyphenated Format 47335-703

Supplemental Identifiers

RxCUI
630208
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 ANDA207857 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • .83 mg/mL
source: ndc
Packaging
  • 5 POUCH in 1 CARTON (47335-703-49) / 5 VIAL in 1 POUCH / 3 mL in 1 VIAL
  • 6 POUCH in 1 CARTON (47335-703-52) / 5 VIAL in 1 POUCH / 3 mL in 1 VIAL
  • 12 POUCH in 1 CARTON (47335-703-54) / 5 VIAL in 1 POUCH / 3 mL in 1 VIAL
source: ndc

Packages (3)

47335-703-49 5 POUCH in 1 CARTON (47335-703-49) / 5 VIAL in 1 POUCH / 3 mL in 1 VIAL 47335-703-52 6 POUCH in 1 CARTON (47335-703-52) / 5 VIAL in 1 POUCH / 3 mL in 1 VIAL 47335-703-54 12 POUCH in 1 CARTON (47335-703-54) / 5 VIAL in 1 POUCH / 3 mL in 1 VIAL

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": "2833984c-f479-4e90-b947-80df3d3111f7", "openfda": {"unii": ["021SEF3731"], "rxcui": ["630208"], "spl_set_id": ["bb538b7d-e390-419a-9404-a57c1db4a447"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 POUCH in 1 CARTON (47335-703-49)  / 5 VIAL in 1 POUCH / 3 mL in 1 VIAL", "package_ndc": "47335-703-49", "marketing_start_date": "20210611"}, {"sample": false, "description": "6 POUCH in 1 CARTON (47335-703-52)  / 5 VIAL in 1 POUCH / 3 mL in 1 VIAL", "package_ndc": "47335-703-52", "marketing_start_date": "20210611"}, {"sample": false, "description": "12 POUCH in 1 CARTON (47335-703-54)  / 5 VIAL in 1 POUCH / 3 mL in 1 VIAL", "package_ndc": "47335-703-54", "marketing_start_date": "20210611"}], "brand_name": "Albuterol Sulfate", "product_id": "47335-703_2833984c-f479-4e90-b947-80df3d3111f7", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "47335-703", "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": ".83 mg/mL"}], "application_number": "ANDA207857", "marketing_category": "ANDA", "marketing_start_date": "20210611", "listing_expiration_date": "20261231"}