albuterol sulfate

Generic: albuterol sulfate

Labeler: mylan pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name albuterol sulfate
Generic Name albuterol sulfate
Labeler mylan pharmaceuticals inc.
Dosage Form SOLUTION
Routes
RESPIRATORY (INHALATION)
Active Ingredients

albuterol sulfate .63 mg/3mL

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-7057
Product ID 0378-7057_de8e18d1-bd6b-484a-a7b4-3c286c8ae917
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214531
Listing Expiration 2026-12-31
Marketing Start 2022-10-07

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03787057
Hyphenated Format 0378-7057

Supplemental Identifiers

RxCUI
351136 351137
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 ANDA214531 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • .63 mg/3mL
source: ndc
Packaging
  • 5 POUCH in 1 CARTON (0378-7057-52) / 5 VIAL in 1 POUCH (0378-7057-98) / 3 mL in 1 VIAL
source: ndc

Packages (1)

0378-7057-52 5 POUCH in 1 CARTON (0378-7057-52) / 5 VIAL in 1 POUCH (0378-7057-98) / 3 mL in 1 VIAL

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": "de8e18d1-bd6b-484a-a7b4-3c286c8ae917", "openfda": {"unii": ["021SEF3731"], "rxcui": ["351136", "351137"], "spl_set_id": ["9e6e982b-7dfe-45b8-aa76-754e8d2a8ef6"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 POUCH in 1 CARTON (0378-7057-52)  / 5 VIAL in 1 POUCH (0378-7057-98)  / 3 mL in 1 VIAL", "package_ndc": "0378-7057-52", "marketing_start_date": "20221007"}], "brand_name": "Albuterol Sulfate", "product_id": "0378-7057_de8e18d1-bd6b-484a-a7b4-3c286c8ae917", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "0378-7057", "generic_name": "Albuterol Sulfate", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Albuterol Sulfate", "active_ingredients": [{"name": "ALBUTEROL SULFATE", "strength": ".63 mg/3mL"}], "application_number": "ANDA214531", "marketing_category": "ANDA", "marketing_start_date": "20221007", "listing_expiration_date": "20261231"}