levalbuterol inhalation

Generic: levalbuterol inhalation 0.63mg/3ml

Labeler: dr. reddys laboratories, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levalbuterol inhalation
Generic Name levalbuterol inhalation 0.63mg/3ml
Labeler dr. reddys laboratories, inc.
Dosage Form SOLUTION
Routes
RESPIRATORY (INHALATION)
Active Ingredients

levalbuterol .63 mg/3mL

Manufacturer
Dr. Reddys Laboratories, Inc.

Identifiers & Regulatory

Product NDC 43598-410
Product ID 43598-410_8434771a-e4b6-e76a-1593-be9a47126006
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078171
Listing Expiration 2026-12-31
Marketing Start 2014-09-16

Pharmacologic Class

Established (EPC)
beta2-adrenergic agonist [epc]
Mechanism of Action
adrenergic beta2-agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43598410
Hyphenated Format 43598-410

Supplemental Identifiers

RxCUI
242754 311286 349590
UPC
0343598410258
UNII
EDN2NBH5SS
NUI
N0000009922 N0000175779

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 inhalation (source: ndc)
Generic Name levalbuterol inhalation 0.63mg/3ml (source: ndc)
Application Number ANDA078171 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • .63 mg/3mL
source: ndc
Packaging
  • 5 POUCH in 1 CARTON (43598-410-25) / 5 VIAL in 1 POUCH (43598-410-05) / 3 mL in 1 VIAL
source: ndc

Packages (1)

43598-410-25 5 POUCH in 1 CARTON (43598-410-25) / 5 VIAL in 1 POUCH (43598-410-05) / 3 mL in 1 VIAL

Ingredients (1)

levalbuterol (.63 mg/3mL)

Linked Drug Pages (1)

levalbuterol inhalation ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["RESPIRATORY (INHALATION)"], "spl_id": "8434771a-e4b6-e76a-1593-be9a47126006", "openfda": {"nui": ["N0000009922", "N0000175779"], "upc": ["0343598410258"], "unii": ["EDN2NBH5SS"], "rxcui": ["242754", "311286", "349590"], "spl_set_id": ["163dfa7c-aad3-4290-9fe9-d9592b0ba317"], "pharm_class_epc": ["beta2-Adrenergic Agonist [EPC]"], "pharm_class_moa": ["Adrenergic beta2-Agonists [MoA]"], "manufacturer_name": ["Dr. Reddys Laboratories, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 POUCH in 1 CARTON (43598-410-25)  / 5 VIAL in 1 POUCH (43598-410-05)  / 3 mL in 1 VIAL", "package_ndc": "43598-410-25", "marketing_start_date": "20140916"}], "brand_name": "levalbuterol inhalation", "product_id": "43598-410_8434771a-e4b6-e76a-1593-be9a47126006", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "43598-410", "generic_name": "levalbuterol inhalation 0.63mg/3mL", "labeler_name": "Dr. Reddys Laboratories, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "levalbuterol inhalation", "active_ingredients": [{"name": "LEVALBUTEROL", "strength": ".63 mg/3mL"}], "application_number": "ANDA078171", "marketing_category": "ANDA", "marketing_start_date": "20140916", "listing_expiration_date": "20261231"}