albuterol sulfate

Generic: albuterol sulfate

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

Drug Facts

Product Profile

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

albuterol sulfate 2.5 mg/3mL

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8399
Product ID 68788-8399_ff08ba3b-5da2-4a99-a931-72c24d5a1835
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077839
Listing Expiration 2027-12-31
Marketing Start 2023-03-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 687888399
Hyphenated Format 68788-8399

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 ANDA077839 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/3mL
source: ndc
Packaging
  • 25 AMPULE in 1 POUCH (68788-8399-2) / 3 mL in 1 AMPULE
source: ndc

Packages (1)

68788-8399-2 25 AMPULE in 1 POUCH (68788-8399-2) / 3 mL in 1 AMPULE

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": "ff08ba3b-5da2-4a99-a931-72c24d5a1835", "openfda": {"unii": ["021SEF3731"], "rxcui": ["630208"], "spl_set_id": ["c90e80b2-882e-4c0c-bfac-d67eb1da724d"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "25 AMPULE in 1 POUCH (68788-8399-2)  / 3 mL in 1 AMPULE", "package_ndc": "68788-8399-2", "marketing_start_date": "20230301"}], "brand_name": "Albuterol Sulfate", "product_id": "68788-8399_ff08ba3b-5da2-4a99-a931-72c24d5a1835", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "68788-8399", "generic_name": "Albuterol Sulfate", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Albuterol Sulfate", "active_ingredients": [{"name": "ALBUTEROL SULFATE", "strength": "2.5 mg/3mL"}], "application_number": "ANDA077839", "marketing_category": "ANDA", "marketing_start_date": "20230301", "listing_expiration_date": "20271231"}