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 2.5 mg/.5mL

Manufacturer
Chartwell RX, LLC.

Identifiers & Regulatory

Product NDC 62135-829
Product ID 62135-829_11e58070-ecf6-06b9-e063-6394a90adaba
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075664
Listing Expiration 2026-12-31
Marketing Start 2001-06-26

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62135829
Hyphenated Format 62135-829

Supplemental Identifiers

RxCUI
245314
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 ANDA075664 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/.5mL
source: ndc
Packaging
  • 30 POUCH in 1 CARTON (62135-829-84) / 1 VIAL, SINGLE-DOSE in 1 POUCH / .5 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

62135-829-84 30 POUCH in 1 CARTON (62135-829-84) / 1 VIAL, SINGLE-DOSE in 1 POUCH / .5 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

albuterol sulfate (2.5 mg/.5mL)

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": "11e58070-ecf6-06b9-e063-6394a90adaba", "openfda": {"unii": ["021SEF3731"], "rxcui": ["245314"], "spl_set_id": ["7f261a9b-65d9-408a-8609-c1b3809b8b4b"], "manufacturer_name": ["Chartwell RX, LLC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 POUCH in 1 CARTON (62135-829-84)  / 1 VIAL, SINGLE-DOSE in 1 POUCH / .5 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "62135-829-84", "marketing_start_date": "20240123"}], "brand_name": "Albuterol Sulfate", "product_id": "62135-829_11e58070-ecf6-06b9-e063-6394a90adaba", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "62135-829", "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": "2.5 mg/.5mL"}], "application_number": "ANDA075664", "marketing_category": "ANDA", "marketing_start_date": "20010626", "listing_expiration_date": "20261231"}