albuterol sulfate (0378-8270)

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 2.5 mg/3mL

Manufacturer

Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-8270

Product ID 0378-8270_6c181118-680f-4e62-b0d3-057a14803a4f

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA077839

Listing Expiration 2026-12-31

Marketing Start 2012-10-15

Pharmacologic Class

Classes

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03788270

Hyphenated Format 0378-8270

Supplemental Identifiers

RxCUI

630208

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 ANDA077839 (source: ndc)

Routes

RESPIRATORY (INHALATION)

source: ndc

Resolved Composition

Strengths

2.5 mg/3mL

source: ndc

Packaging

1 POUCH in 1 CARTON (0378-8270-52) / 25 AMPULE in 1 POUCH (0378-8270-62) / 3 mL in 1 AMPULE
30 POUCH in 1 CARTON (0378-8270-55) / 1 AMPULE in 1 POUCH (0378-8270-31) / 3 mL in 1 AMPULE
2 POUCH in 1 CARTON (0378-8270-91) / 30 AMPULE in 1 POUCH (0378-8270-64) / 3 mL in 1 AMPULE
1 POUCH in 1 CARTON (0378-8270-93) / 30 AMPULE in 1 POUCH / 3 mL in 1 AMPULE

source: ndc

Packages (4)

0378-8270-52 1 POUCH in 1 CARTON (0378-8270-52) / 25 AMPULE in 1 POUCH (0378-8270-62) / 3 mL in 1 AMPULE 0378-8270-55 30 POUCH in 1 CARTON (0378-8270-55) / 1 AMPULE in 1 POUCH (0378-8270-31) / 3 mL in 1 AMPULE 0378-8270-91 2 POUCH in 1 CARTON (0378-8270-91) / 30 AMPULE in 1 POUCH (0378-8270-64) / 3 mL in 1 AMPULE 0378-8270-93 1 POUCH in 1 CARTON (0378-8270-93) / 30 AMPULE in 1 POUCH / 3 mL in 1 AMPULE

Ingredients (1)

albuterol sulfate (2.5 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": "6c181118-680f-4e62-b0d3-057a14803a4f", "openfda": {"unii": ["021SEF3731"], "rxcui": ["630208"], "spl_set_id": ["5329614f-ae0b-4854-bb6f-ea0b7dae87c0"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 POUCH in 1 CARTON (0378-8270-52)  / 25 AMPULE in 1 POUCH (0378-8270-62)  / 3 mL in 1 AMPULE", "package_ndc": "0378-8270-52", "marketing_start_date": "20121218"}, {"sample": false, "description": "30 POUCH in 1 CARTON (0378-8270-55)  / 1 AMPULE in 1 POUCH (0378-8270-31)  / 3 mL in 1 AMPULE", "package_ndc": "0378-8270-55", "marketing_start_date": "20140306"}, {"sample": false, "description": "2 POUCH in 1 CARTON (0378-8270-91)  / 30 AMPULE in 1 POUCH (0378-8270-64)  / 3 mL in 1 AMPULE", "package_ndc": "0378-8270-91", "marketing_start_date": "20130411"}, {"sample": false, "description": "1 POUCH in 1 CARTON (0378-8270-93)  / 30 AMPULE in 1 POUCH / 3 mL in 1 AMPULE", "package_ndc": "0378-8270-93", "marketing_start_date": "20130122"}], "brand_name": "Albuterol Sulfate", "product_id": "0378-8270_6c181118-680f-4e62-b0d3-057a14803a4f", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "0378-8270", "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": "2.5 mg/3mL"}], "application_number": "ANDA077839", "marketing_category": "ANDA", "marketing_start_date": "20121015", "listing_expiration_date": "20261231"}