albuterol

Generic: albuterol

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

Drug Facts

Product Profile

Brand Name albuterol
Generic Name albuterol
Labeler zydus pharmaceuticals usa inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

albuterol sulfate 4 mg/1

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 70710-1062
Product ID 70710-1062_1d5b3219-efd5-4842-9b6e-2ea1874d0d4d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208884
Listing Expiration 2026-12-31
Marketing Start 2020-10-23

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 707101062
Hyphenated Format 70710-1062

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 ANDA208884 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (70710-1062-1)
  • 500 TABLET in 1 BOTTLE (70710-1062-5)
source: ndc

Packages (2)

70710-1062-1 100 TABLET in 1 BOTTLE (70710-1062-1) 70710-1062-5 500 TABLET in 1 BOTTLE (70710-1062-5)

Ingredients (1)

albuterol sulfate (4 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": "1d5b3219-efd5-4842-9b6e-2ea1874d0d4d", "openfda": {"unii": ["021SEF3731"], "rxcui": ["197316", "197318"], "spl_set_id": ["c3fa0068-fd12-45de-818e-e929fb45ba05"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (70710-1062-1)", "package_ndc": "70710-1062-1", "marketing_start_date": "20201023"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (70710-1062-5)", "package_ndc": "70710-1062-5", "marketing_start_date": "20201023"}], "brand_name": "Albuterol", "product_id": "70710-1062_1d5b3219-efd5-4842-9b6e-2ea1874d0d4d", "dosage_form": "TABLET", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "70710-1062", "generic_name": "Albuterol", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Albuterol", "active_ingredients": [{"name": "ALBUTEROL SULFATE", "strength": "4 mg/1"}], "application_number": "ANDA208884", "marketing_category": "ANDA", "marketing_start_date": "20201023", "listing_expiration_date": "20261231"}