albuterol sulfate

Generic: albuterol sulfate

Labeler: american health packaging
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name albuterol sulfate
Generic Name albuterol sulfate
Labeler american health packaging
Dosage Form TABLET
Routes
ORAL
Active Ingredients

albuterol sulfate 2 mg/1

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 68084-949
Product ID 68084-949_1e7d3421-f562-17f5-e063-6294a90a9358
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA072637
Listing Expiration 2026-12-31
Marketing Start 2015-09-22

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68084949
Hyphenated Format 68084-949

Supplemental Identifiers

RxCUI
197316 197318
UNII
021SEF3731

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 ANDA072637 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-949-25) / 1 TABLET in 1 BLISTER PACK (68084-949-95)
source: ndc

Packages (1)

68084-949-25 30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-949-25) / 1 TABLET in 1 BLISTER PACK (68084-949-95)

Ingredients (1)

albuterol sulfate (2 mg/1)

Linked Drug Pages (1)

Albuterol Sulfate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1e7d3421-f562-17f5-e063-6294a90a9358", "openfda": {"unii": ["021SEF3731"], "rxcui": ["197316", "197318"], "spl_set_id": ["b0f73459-baeb-42a7-be48-2c3647d9b205"], "manufacturer_name": ["American Health Packaging"]}, "finished": true, "packaging": [{"sample": false, "description": "30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-949-25)  / 1 TABLET in 1 BLISTER PACK (68084-949-95)", "package_ndc": "68084-949-25", "marketing_start_date": "20150922"}], "brand_name": "Albuterol Sulfate", "product_id": "68084-949_1e7d3421-f562-17f5-e063-6294a90a9358", "dosage_form": "TABLET", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "68084-949", "generic_name": "Albuterol Sulfate", "labeler_name": "American Health Packaging", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Albuterol Sulfate", "active_ingredients": [{"name": "ALBUTEROL SULFATE", "strength": "2 mg/1"}], "application_number": "ANDA072637", "marketing_category": "ANDA", "marketing_start_date": "20150922", "listing_expiration_date": "20261231"}