albuterol sulfate

Generic: albuterol sulfate

Labeler: chartwell rx, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name albuterol sulfate
Generic Name albuterol sulfate
Labeler chartwell rx, llc
Dosage Form SOLUTION
Routes
RESPIRATORY (INHALATION)
Active Ingredients

albuterol sulfate 1.25 mg/3mL

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-827
Product ID 62135-827_11e59625-431b-e530-e063-6294a90a0596
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076355
Listing Expiration 2026-12-31
Marketing Start 2004-06-28

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62135827
Hyphenated Format 62135-827

Supplemental Identifiers

RxCUI
351136 351137
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 ANDA076355 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • 1.25 mg/3mL
source: ndc
Packaging
  • 30 POUCH in 1 CARTON (62135-827-84) / 1 VIAL in 1 POUCH / 3 mL in 1 VIAL
source: ndc

Packages (1)

62135-827-84 30 POUCH in 1 CARTON (62135-827-84) / 1 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": "11e59625-431b-e530-e063-6294a90a0596", "openfda": {"unii": ["021SEF3731"], "rxcui": ["351136", "351137"], "spl_set_id": ["4e48ccbe-3ec0-4bf2-be28-83eb9baa63d6"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 POUCH in 1 CARTON (62135-827-84)  / 1 VIAL in 1 POUCH / 3 mL in 1 VIAL", "package_ndc": "62135-827-84", "marketing_start_date": "20240119"}], "brand_name": "Albuterol Sulfate", "product_id": "62135-827_11e59625-431b-e530-e063-6294a90a0596", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "62135-827", "generic_name": "Albuterol Sulfate", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Albuterol Sulfate", "active_ingredients": [{"name": "ALBUTEROL SULFATE", "strength": "1.25 mg/3mL"}], "application_number": "ANDA076355", "marketing_category": "ANDA", "marketing_start_date": "20040628", "listing_expiration_date": "20261231"}