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 .83 mg/mL

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8492
Product ID 68788-8492_84a25c79-3c24-4979-b295-2495b90eb295
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207857
Listing Expiration 2027-12-31
Marketing Start 2023-07-24

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 687888492
Hyphenated Format 68788-8492

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 ANDA207857 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • .83 mg/mL
source: ndc
Packaging
  • 5 POUCH in 1 CARTON (68788-8492-2) / 5 VIAL in 1 POUCH / 3 mL in 1 VIAL
source: ndc

Packages (1)

68788-8492-2 5 POUCH in 1 CARTON (68788-8492-2) / 5 VIAL in 1 POUCH / 3 mL in 1 VIAL

Ingredients (1)

albuterol sulfate (.83 mg/mL)

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": "84a25c79-3c24-4979-b295-2495b90eb295", "openfda": {"unii": ["021SEF3731"], "rxcui": ["630208"], "spl_set_id": ["5de6a189-a8b7-4b33-b162-add6b6e4b275"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "5 POUCH in 1 CARTON (68788-8492-2)  / 5 VIAL in 1 POUCH / 3 mL in 1 VIAL", "package_ndc": "68788-8492-2", "marketing_start_date": "20230724"}], "brand_name": "Albuterol Sulfate", "product_id": "68788-8492_84a25c79-3c24-4979-b295-2495b90eb295", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "68788-8492", "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": ".83 mg/mL"}], "application_number": "ANDA207857", "marketing_category": "ANDA", "marketing_start_date": "20230724", "listing_expiration_date": "20271231"}