proair digihaler

Generic: albuterol sulfate

Labeler: teva respiratory, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name proair digihaler
Generic Name albuterol sulfate
Labeler teva respiratory, llc
Dosage Form INHALANT
Routes
RESPIRATORY (INHALATION)
Active Ingredients

albuterol sulfate 90 ug/1

Manufacturer
Teva Respiratory, LLC

Identifiers & Regulatory

Product NDC 59310-117
Product ID 59310-117_6d6a3e12-ee60-4cec-9f1b-df00c47b769f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA205636
Listing Expiration 2026-12-31
Marketing Start 2019-10-04

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59310117
Hyphenated Format 59310-117

Supplemental Identifiers

RxCUI
2166796 2166797
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 proair digihaler (source: ndc)
Generic Name albuterol sulfate (source: ndc)
Application Number NDA205636 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • 90 ug/1
source: ndc
Packaging
  • 1 INHALER in 1 BOX (59310-117-20) / 200 INHALANT in 1 INHALER
source: ndc

Packages (1)

Ingredients (1)

albuterol sulfate (90 ug/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["RESPIRATORY (INHALATION)"], "spl_id": "6d6a3e12-ee60-4cec-9f1b-df00c47b769f", "openfda": {"unii": ["021SEF3731"], "rxcui": ["2166796", "2166797"], "spl_set_id": ["667ce3ec-5217-4b10-b712-f3e54fbbf087"], "manufacturer_name": ["Teva Respiratory, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 INHALER in 1 BOX (59310-117-20)  / 200 INHALANT in 1 INHALER", "package_ndc": "59310-117-20", "marketing_start_date": "20191004"}], "brand_name": "ProAir Digihaler", "product_id": "59310-117_6d6a3e12-ee60-4cec-9f1b-df00c47b769f", "dosage_form": "INHALANT", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "59310-117", "generic_name": "albuterol sulfate", "labeler_name": "Teva Respiratory, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ProAir Digihaler", "active_ingredients": [{"name": "ALBUTEROL SULFATE", "strength": "90 ug/1"}], "application_number": "NDA205636", "marketing_category": "NDA", "marketing_start_date": "20191004", "listing_expiration_date": "20261231"}