albuterol sulfate

Generic: albuterol sulfate

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

Drug Facts

Product Profile

Brand Name albuterol sulfate
Generic Name albuterol sulfate
Labeler rising pharma holdings, inc
Dosage Form SOLUTION
Routes
RESPIRATORY (INHALATION)
Active Ingredients

albuterol sulfate .63 mg/3mL

Manufacturer
Rising Pharma Holdings, Inc

Identifiers & Regulatory

Product NDC 64980-643
Product ID 64980-643_3301695d-8226-0f9b-e063-6394a90a9582
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076355
Listing Expiration 2026-12-31
Marketing Start 2025-04-14

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64980643
Hyphenated Format 64980-643

Supplemental Identifiers

RxCUI
351136 351137
UPC
0364980643030 0364980644020
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 sulfate (source: ndc)
Generic Name albuterol sulfate (source: ndc)
Application Number ANDA076355 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • .63 mg/3mL
source: ndc
Packaging
  • 30 POUCH in 1 CARTON (64980-643-03) / 1 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

64980-643-03 30 POUCH in 1 CARTON (64980-643-03) / 1 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

albuterol sulfate (.63 mg/3mL)

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": "3301695d-8226-0f9b-e063-6394a90a9582", "openfda": {"upc": ["0364980643030", "0364980644020"], "unii": ["021SEF3731"], "rxcui": ["351136", "351137"], "spl_set_id": ["32474c0e-af35-69d1-e063-6394a90a53c6"], "manufacturer_name": ["Rising Pharma Holdings, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 POUCH in 1 CARTON (64980-643-03)  / 1 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "64980-643-03", "marketing_start_date": "20250430"}], "brand_name": "Albuterol Sulfate", "product_id": "64980-643_3301695d-8226-0f9b-e063-6394a90a9582", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "64980-643", "generic_name": "Albuterol Sulfate", "labeler_name": "Rising Pharma Holdings, Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Albuterol Sulfate", "active_ingredients": [{"name": "ALBUTEROL SULFATE", "strength": ".63 mg/3mL"}], "application_number": "ANDA076355", "marketing_category": "ANDA", "marketing_start_date": "20250414", "listing_expiration_date": "20261231"}