levalbuterol

Generic: levalbuterol hydrochloride

Labeler: ritedose pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levalbuterol
Generic Name levalbuterol hydrochloride
Labeler ritedose pharmaceuticals, llc
Dosage Form SOLUTION
Routes
RESPIRATORY (INHALATION)
Active Ingredients

levalbuterol hydrochloride .63 mg/3mL

Manufacturer
Ritedose Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 76204-800
Product ID 76204-800_459fa0f5-35d9-d6e5-e063-6394a90a6f14
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203653
Listing Expiration 2026-12-31
Marketing Start 2016-03-22

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76204800
Hyphenated Format 76204-800

Supplemental Identifiers

RxCUI
242754 311286 349590
UPC
0376204900010 0376204800259 0376204700559 0376204800013 0376204700016 0376204800556 0376204900256 0376204900553
UNII
WDQ1526QJM

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 levalbuterol (source: ndc)
Generic Name levalbuterol hydrochloride (source: ndc)
Application Number ANDA203653 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • .63 mg/3mL
source: ndc
Packaging
  • 30 POUCH in 1 CARTON (76204-800-01) / 1 AMPULE in 1 POUCH (76204-800-11) / 3 mL in 1 AMPULE
  • 1 POUCH in 1 CARTON (76204-800-25) / 25 AMPULE in 1 POUCH (76204-800-15) / 3 mL in 1 AMPULE
  • 5 POUCH in 1 CARTON (76204-800-55) / 5 AMPULE in 1 POUCH (76204-800-05) / 3 mL in 1 AMPULE
source: ndc

Packages (3)

76204-800-01 30 POUCH in 1 CARTON (76204-800-01) / 1 AMPULE in 1 POUCH (76204-800-11) / 3 mL in 1 AMPULE 76204-800-25 1 POUCH in 1 CARTON (76204-800-25) / 25 AMPULE in 1 POUCH (76204-800-15) / 3 mL in 1 AMPULE 76204-800-55 5 POUCH in 1 CARTON (76204-800-55) / 5 AMPULE in 1 POUCH (76204-800-05) / 3 mL in 1 AMPULE

Ingredients (1)

levalbuterol hydrochloride (.63 mg/3mL)

Linked Drug Pages (1)

Levalbuterol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["RESPIRATORY (INHALATION)"], "spl_id": "459fa0f5-35d9-d6e5-e063-6394a90a6f14", "openfda": {"upc": ["0376204900010", "0376204800259", "0376204700559", "0376204800013", "0376204700016", "0376204800556", "0376204900256", "0376204900553"], "unii": ["WDQ1526QJM"], "rxcui": ["242754", "311286", "349590"], "spl_set_id": ["d6998949-e1cb-4c86-a480-c0dfd9cb75b5"], "manufacturer_name": ["Ritedose Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 POUCH in 1 CARTON (76204-800-01)  / 1 AMPULE in 1 POUCH (76204-800-11)  / 3 mL in 1 AMPULE", "package_ndc": "76204-800-01", "marketing_start_date": "20170217"}, {"sample": false, "description": "1 POUCH in 1 CARTON (76204-800-25)  / 25 AMPULE in 1 POUCH (76204-800-15)  / 3 mL in 1 AMPULE", "package_ndc": "76204-800-25", "marketing_start_date": "20170217"}, {"sample": false, "description": "5 POUCH in 1 CARTON (76204-800-55)  / 5 AMPULE in 1 POUCH (76204-800-05)  / 3 mL in 1 AMPULE", "package_ndc": "76204-800-55", "marketing_start_date": "20170217"}], "brand_name": "Levalbuterol", "product_id": "76204-800_459fa0f5-35d9-d6e5-e063-6394a90a6f14", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "76204-800", "generic_name": "Levalbuterol Hydrochloride", "labeler_name": "Ritedose Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levalbuterol", "active_ingredients": [{"name": "LEVALBUTEROL HYDROCHLORIDE", "strength": ".63 mg/3mL"}], "application_number": "ANDA203653", "marketing_category": "ANDA", "marketing_start_date": "20160322", "listing_expiration_date": "20261231"}