albuterol sulfate (76204-200)

Drug Facts

Product Profile

Brand Name albuterol sulfate

Generic Name albuterol sulfate

Labeler ritedose pharmaceuticals, llc

Dosage Form SOLUTION

Routes

RESPIRATORY (INHALATION)

Active Ingredients

albuterol sulfate 2.5 mg/3mL

Manufacturer

Ritedose Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 76204-200

Product ID 76204-200_45c72cc7-5253-0229-e063-6394a90a596f

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA077839

Listing Expiration 2026-12-31

Marketing Start 2011-12-05

Pharmacologic Class

Classes

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76204200

Hyphenated Format 76204-200

Supplemental Identifiers

RxCUI

630208

UPC

0376204200608 0376204200257 0376204200011 0376204200301

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

30 POUCH in 1 CARTON (76204-200-01) / 1 AMPULE in 1 POUCH / 3 mL in 1 AMPULE
1 POUCH in 1 CARTON (76204-200-25) / 25 AMPULE in 1 POUCH / 3 mL in 1 AMPULE
1 POUCH in 1 CARTON (76204-200-30) / 30 AMPULE in 1 POUCH / 3 mL in 1 AMPULE
2 POUCH in 1 CARTON (76204-200-60) / 30 AMPULE in 1 POUCH / 3 mL in 1 AMPULE

source: ndc

Packages (4)

76204-200-01 30 POUCH in 1 CARTON (76204-200-01) / 1 AMPULE in 1 POUCH / 3 mL in 1 AMPULE 76204-200-25 1 POUCH in 1 CARTON (76204-200-25) / 25 AMPULE in 1 POUCH / 3 mL in 1 AMPULE 76204-200-30 1 POUCH in 1 CARTON (76204-200-30) / 30 AMPULE in 1 POUCH / 3 mL in 1 AMPULE 76204-200-60 2 POUCH in 1 CARTON (76204-200-60) / 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": "45c72cc7-5253-0229-e063-6394a90a596f", "openfda": {"upc": ["0376204200608", "0376204200257", "0376204200011", "0376204200301"], "unii": ["021SEF3731"], "rxcui": ["630208"], "spl_set_id": ["b72742df-1a6b-4483-aff3-3e79db5e015d"], "manufacturer_name": ["Ritedose Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 POUCH in 1 CARTON (76204-200-01)  / 1 AMPULE in 1 POUCH / 3 mL in 1 AMPULE", "package_ndc": "76204-200-01", "marketing_start_date": "20111205"}, {"sample": false, "description": "1 POUCH in 1 CARTON (76204-200-25)  / 25 AMPULE in 1 POUCH / 3 mL in 1 AMPULE", "package_ndc": "76204-200-25", "marketing_start_date": "20111205"}, {"sample": false, "description": "1 POUCH in 1 CARTON (76204-200-30)  / 30 AMPULE in 1 POUCH / 3 mL in 1 AMPULE", "package_ndc": "76204-200-30", "marketing_start_date": "20111205"}, {"sample": false, "description": "2 POUCH in 1 CARTON (76204-200-60)  / 30 AMPULE in 1 POUCH / 3 mL in 1 AMPULE", "package_ndc": "76204-200-60", "marketing_start_date": "20111205"}], "brand_name": "Albuterol Sulfate", "product_id": "76204-200_45c72cc7-5253-0229-e063-6394a90a596f", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "76204-200", "generic_name": "Albuterol Sulfate", "labeler_name": "Ritedose Pharmaceuticals, LLC", "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": "20111205", "listing_expiration_date": "20261231"}