ProAir Digihaler

Generic: Albuterol Sulfate

Labeler: Teva Respiratory, LLC
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive

Drug Facts

Product Profile

Brand Name ProAir Digihaler
Generic Name Albuterol Sulfate
Labeler Teva Respiratory, LLC
Dosage Form POWDER, METERED
Routes
RESPIRATORY (INHALATION)
Active Ingredients

ALBUTEROL SULFATE 90 ug/1

Identifiers & Regulatory

Product NDC 59310-540
Product ID 59310-540_6d6a3e12-ee60-4cec-9f1b-df00c47b769f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA205636
Marketing Start 2019-10-04
Marketing End 2026-02-28

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59310540
Hyphenated Format 59310-540

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 (59310-540-20) / 200 POWDER, METERED in 1 INHALER
source: ndc

Packages (1)

59310-540-20 1 INHALER in 1 BOX (59310-540-20) / 200 POWDER, METERED in 1 INHALER

Ingredients (1)

ALBUTEROL SULFATE (90 ug/1)

Linked Drug Pages (1)

ProAir Digihaler ndc-match (0.9)

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": true, "description": "1 INHALER in 1 BOX (59310-540-20)  / 200 POWDER, METERED in 1 INHALER", "package_ndc": "59310-540-20", "marketing_end_date": "20260228", "marketing_start_date": "20191004"}], "brand_name": "ProAir Digihaler", "product_id": "59310-540_6d6a3e12-ee60-4cec-9f1b-df00c47b769f", "dosage_form": "POWDER, METERED", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "59310-540", "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_end_date": "20260228", "marketing_start_date": "20191004"}