albuterol sulfate

Generic: albuterol sulfate

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name albuterol sulfate
Generic Name albuterol sulfate
Labeler proficient rx lp
Dosage Form SOLUTION
Routes
RESPIRATORY (INHALATION)
Active Ingredients

albuterol sulfate 2.5 mg/3mL

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 63187-204
Product ID 63187-204_621471a7-e06e-4d18-be4b-aca66c225a39
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 63187204
Hyphenated Format 63187-204

Supplemental Identifiers

RxCUI
630208
UPC
0363187204259
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 (63187-204-25) / 25 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

63187-204-25 1 POUCH in 1 CARTON (63187-204-25) / 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 (1)

Albuterol Sulfate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["RESPIRATORY (INHALATION)"], "spl_id": "621471a7-e06e-4d18-be4b-aca66c225a39", "openfda": {"upc": ["0363187204259"], "unii": ["021SEF3731"], "rxcui": ["630208"], "spl_set_id": ["d3d2ab1e-8f91-4a4d-aa6b-5a57f59ad56b"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "1 POUCH in 1 CARTON (63187-204-25)  / 25 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "63187-204-25", "marketing_start_date": "20181101"}], "brand_name": "Albuterol Sulfate", "product_id": "63187-204_621471a7-e06e-4d18-be4b-aca66c225a39", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "63187-204", "generic_name": "Albuterol Sulfate", "labeler_name": "Proficient Rx LP", "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"}