albuterol sulfate

Generic: albuterol sulfate

Labeler: asclemed usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name albuterol sulfate
Generic Name albuterol sulfate
Labeler asclemed usa, inc.
Dosage Form SOLUTION
Routes
RESPIRATORY (INHALATION)
Active Ingredients

albuterol sulfate 2.5 mg/3mL

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-087
Product ID 76420-087_42f01933-6ed0-b7b0-e063-6394a90ab9e9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074880
Listing Expiration 2026-12-31
Marketing Start 1997-09-17

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76420087
Hyphenated Format 76420-087

Supplemental Identifiers

RxCUI
630208
UNII
021SEF3731

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 ANDA074880 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/3mL
source: ndc
Packaging
  • 1 POUCH in 1 CARTON (76420-087-25) / 25 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

76420-087-25 1 POUCH in 1 CARTON (76420-087-25) / 25 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

albuterol sulfate (2.5 mg/3mL)

Linked Drug Pages (2)

Albuterol Sulfate ndc-match (0.9) Albuterol Sulfate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["RESPIRATORY (INHALATION)"], "spl_id": "42f01933-6ed0-b7b0-e063-6394a90ab9e9", "openfda": {"unii": ["021SEF3731"], "rxcui": ["630208"], "spl_set_id": ["056e145b-87aa-4009-a7ab-2ac0bd086eb0"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 POUCH in 1 CARTON (76420-087-25)  / 25 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "76420-087-25", "marketing_start_date": "20251106"}], "brand_name": "Albuterol Sulfate", "product_id": "76420-087_42f01933-6ed0-b7b0-e063-6394a90ab9e9", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "76420-087", "generic_name": "Albuterol Sulfate", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Albuterol Sulfate", "active_ingredients": [{"name": "ALBUTEROL SULFATE", "strength": "2.5 mg/3mL"}], "application_number": "ANDA074880", "marketing_category": "ANDA", "marketing_start_date": "19970917", "listing_expiration_date": "20261231"}