albuterol sulfate (87063-031)

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 87063-031

Product ID 87063-031_430d292d-dcb0-a30d-e063-6294a90ae859

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 87063031

Hyphenated Format 87063-031

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

30 POUCH in 1 CARTON (87063-031-01) / 1 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE
1 POUCH in 1 CARTON (87063-031-25) / 25 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE
1 POUCH in 1 CARTON (87063-031-30) / 30 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE
2 POUCH in 1 CARTON (87063-031-60) / 30 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE

source: ndc

Packages (4)

87063-031-01 30 POUCH in 1 CARTON (87063-031-01) / 1 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE 87063-031-25 1 POUCH in 1 CARTON (87063-031-25) / 25 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE 87063-031-30 1 POUCH in 1 CARTON (87063-031-30) / 30 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE 87063-031-60 2 POUCH in 1 CARTON (87063-031-60) / 30 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

albuterol sulfate (2.5 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": "430d292d-dcb0-a30d-e063-6294a90ae859", "openfda": {"unii": ["021SEF3731"], "rxcui": ["630208"], "spl_set_id": ["8ea40065-4f59-434f-9ea1-7ef006fde66e"], "manufacturer_name": ["ASCLEMED USA INC."]}, "finished": true, "packaging": [{"sample": false, "description": "30 POUCH in 1 CARTON (87063-031-01)  / 1 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "87063-031-01", "marketing_start_date": "20251107"}, {"sample": false, "description": "1 POUCH in 1 CARTON (87063-031-25)  / 25 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "87063-031-25", "marketing_start_date": "20251107"}, {"sample": false, "description": "1 POUCH in 1 CARTON (87063-031-30)  / 30 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "87063-031-30", "marketing_start_date": "20251107"}, {"sample": false, "description": "2 POUCH in 1 CARTON (87063-031-60)  / 30 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "87063-031-60", "marketing_start_date": "20251107"}], "brand_name": "Albuterol Sulfate", "product_id": "87063-031_430d292d-dcb0-a30d-e063-6294a90ae859", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "87063-031", "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"}