albuterol sulfate

Generic: albuterol sulfate

Labeler: nucare pharmaceuticals,inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

albuterol sulfate 2.5 mg/3mL

Manufacturer
NuCare Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 68071-4754
Product ID 68071-4754_2d7cdf76-7c87-8de1-e063-6394a90a0c2c
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 680714754
Hyphenated Format 68071-4754

Supplemental Identifiers

RxCUI
630208
UPC
0368071475425
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
  • 3 mL in 1 VIAL, SINGLE-DOSE (68071-4754-2)
source: ndc

Packages (1)

68071-4754-2 3 mL in 1 VIAL, SINGLE-DOSE (68071-4754-2)

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": "2d7cdf76-7c87-8de1-e063-6394a90a0c2c", "openfda": {"upc": ["0368071475425"], "unii": ["021SEF3731"], "rxcui": ["630208"], "spl_set_id": ["813d49be-3651-6759-e053-2991aa0a6a9f"], "manufacturer_name": ["NuCare Pharmaceuticals,Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "3 mL in 1 VIAL, SINGLE-DOSE (68071-4754-2)", "package_ndc": "68071-4754-2", "marketing_start_date": "20190206"}], "brand_name": "Albuterol Sulfate", "product_id": "68071-4754_2d7cdf76-7c87-8de1-e063-6394a90a0c2c", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "68071-4754", "generic_name": "Albuterol Sulfate", "labeler_name": "NuCare Pharmaceuticals,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"}