albuterol

Generic: albuterol

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name albuterol
Generic Name albuterol
Labeler rising pharma holdings, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

albuterol sulfate 4 mg/1

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 64980-443
Product ID 64980-443_f3d2f709-6e2e-4c25-8069-52661dc76e2d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207046
Listing Expiration 2026-12-31
Marketing Start 2018-06-29

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64980443
Hyphenated Format 64980-443

Supplemental Identifiers

RxCUI
197316 197318
UPC
0364980443500 0364980443012
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 ANDA207046 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (64980-443-01)
  • 500 TABLET in 1 BOTTLE (64980-443-50)
source: ndc

Packages (2)

64980-443-01 100 TABLET in 1 BOTTLE (64980-443-01) 64980-443-50 500 TABLET in 1 BOTTLE (64980-443-50)

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": "f3d2f709-6e2e-4c25-8069-52661dc76e2d", "openfda": {"upc": ["0364980443500", "0364980443012"], "unii": ["021SEF3731"], "rxcui": ["197316", "197318"], "spl_set_id": ["40f3cdbc-c9ee-4a3c-8061-a44b9a1d035c"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (64980-443-01)", "package_ndc": "64980-443-01", "marketing_start_date": "20180629"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (64980-443-50)", "package_ndc": "64980-443-50", "marketing_start_date": "20180629"}], "brand_name": "Albuterol", "product_id": "64980-443_f3d2f709-6e2e-4c25-8069-52661dc76e2d", "dosage_form": "TABLET", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "64980-443", "generic_name": "albuterol", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Albuterol", "active_ingredients": [{"name": "ALBUTEROL SULFATE", "strength": "4 mg/1"}], "application_number": "ANDA207046", "marketing_category": "ANDA", "marketing_start_date": "20180629", "listing_expiration_date": "20261231"}