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 SYRUP
Routes
ORAL
Active Ingredients

albuterol sulfate 2 mg/5mL

Manufacturer
Preferred Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68788-7573
Product ID 68788-7573_e9b207d7-0c31-45ac-a0ab-8d5b96ffd983
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212197
Listing Expiration 2026-12-31
Marketing Start 2020-05-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 687887573
Hyphenated Format 68788-7573

Supplemental Identifiers

RxCUI
755497
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 ANDA212197 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/5mL
source: ndc
Packaging
  • 473 mL in 1 BOTTLE (68788-7573-4)
source: ndc

Packages (1)

68788-7573-4 473 mL in 1 BOTTLE (68788-7573-4)

Ingredients (1)

albuterol sulfate (2 mg/5mL)

Linked Drug Pages (1)

ALBUTEROL SULFATE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "e9b207d7-0c31-45ac-a0ab-8d5b96ffd983", "openfda": {"unii": ["021SEF3731"], "rxcui": ["755497"], "spl_set_id": ["4aafc2dd-744d-4726-828f-70355aee6f70"], "manufacturer_name": ["Preferred Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE (68788-7573-4)", "package_ndc": "68788-7573-4", "marketing_start_date": "20200501"}], "brand_name": "ALBUTEROL SULFATE", "product_id": "68788-7573_e9b207d7-0c31-45ac-a0ab-8d5b96ffd983", "dosage_form": "SYRUP", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "68788-7573", "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 mg/5mL"}], "application_number": "ANDA212197", "marketing_category": "ANDA", "marketing_start_date": "20200501", "listing_expiration_date": "20261231"}