albuterol

Generic: albuterol

Labeler: amneal pharmaceuticals ny llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name albuterol
Generic Name albuterol
Labeler amneal pharmaceuticals ny llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

albuterol sulfate 2 mg/1

Manufacturer
Amneal Pharmaceuticals NY LLC

Identifiers & Regulatory

Product NDC 69238-1344
Product ID 69238-1344_d66ddd1b-c4f1-461d-b4ec-9362f4880e47
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208804
Listing Expiration 2026-12-31
Marketing Start 2018-05-24

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 692381344
Hyphenated Format 69238-1344

Supplemental Identifiers

RxCUI
197316 197318
UNII
021SEF3731

Packaging Origin

Original Packager
true

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 (source: ndc)
Generic Name albuterol (source: ndc)
Application Number ANDA208804 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (69238-1344-1)
  • 500 TABLET in 1 BOTTLE (69238-1344-5)
source: ndc

Packages (2)

69238-1344-1 100 TABLET in 1 BOTTLE (69238-1344-1) 69238-1344-5 500 TABLET in 1 BOTTLE (69238-1344-5)

Ingredients (1)

albuterol sulfate (2 mg/1)

Linked Drug Pages (1)

Albuterol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "d66ddd1b-c4f1-461d-b4ec-9362f4880e47", "openfda": {"unii": ["021SEF3731"], "rxcui": ["197316", "197318"], "spl_set_id": ["230d66fc-f62c-42a6-adb3-0a0f879c8ad4"], "manufacturer_name": ["Amneal Pharmaceuticals NY LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (69238-1344-1)", "package_ndc": "69238-1344-1", "marketing_start_date": "20180524"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (69238-1344-5)", "package_ndc": "69238-1344-5", "marketing_start_date": "20180524"}], "brand_name": "Albuterol", "product_id": "69238-1344_d66ddd1b-c4f1-461d-b4ec-9362f4880e47", "dosage_form": "TABLET", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "69238-1344", "generic_name": "Albuterol", "labeler_name": "Amneal Pharmaceuticals NY LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Albuterol", "active_ingredients": [{"name": "ALBUTEROL SULFATE", "strength": "2 mg/1"}], "application_number": "ANDA208804", "marketing_category": "ANDA", "marketing_start_date": "20180524", "listing_expiration_date": "20261231"}