levalbuterol

Generic: levalbuterol

Labeler: luoxin aurovitas pharma (chengdu) co., ltd.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levalbuterol
Generic Name levalbuterol
Labeler luoxin aurovitas pharma (chengdu) co., ltd.
Dosage Form SOLUTION
Routes
RESPIRATORY (INHALATION)
Active Ingredients

levalbuterol hydrochloride .31 mg/3mL

Manufacturer
Luoxin Aurovitas Pharma (Chengdu) Co., Ltd.

Identifiers & Regulatory

Product NDC 81894-101
Product ID 81894-101_29ead193-b33d-7f78-e063-6294a90a7ef4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207625
Listing Expiration 2026-12-31
Marketing Start 2016-12-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 81894101
Hyphenated Format 81894-101

Supplemental Identifiers

RxCUI
242754 311286 349590
UPC
0381894101050 0381894101258 0381894102255 0381894103054 0381894102057 0381894103252
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 (source: ndc)
Application Number ANDA207625 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • .31 mg/3mL
source: ndc
Packaging
  • 5 POUCH in 1 CARTON (81894-101-25) / 5 VIAL, SINGLE-DOSE in 1 POUCH (81894-101-05) / 3 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

81894-101-25 5 POUCH in 1 CARTON (81894-101-25) / 5 VIAL, SINGLE-DOSE in 1 POUCH (81894-101-05) / 3 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

levalbuterol hydrochloride (.31 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": "29ead193-b33d-7f78-e063-6294a90a7ef4", "openfda": {"upc": ["0381894101050", "0381894101258", "0381894102255", "0381894103054", "0381894102057", "0381894103252"], "unii": ["WDQ1526QJM"], "rxcui": ["242754", "311286", "349590"], "spl_set_id": ["29eae75d-93da-7a5a-e063-6394a90ac0c0"], "manufacturer_name": ["Luoxin Aurovitas Pharma (Chengdu) Co., Ltd."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 POUCH in 1 CARTON (81894-101-25)  / 5 VIAL, SINGLE-DOSE in 1 POUCH (81894-101-05)  / 3 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "81894-101-25", "marketing_start_date": "20161230"}], "brand_name": "Levalbuterol", "product_id": "81894-101_29ead193-b33d-7f78-e063-6294a90a7ef4", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "81894-101", "generic_name": "Levalbuterol", "labeler_name": "Luoxin Aurovitas Pharma (Chengdu) Co., Ltd.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levalbuterol", "active_ingredients": [{"name": "LEVALBUTEROL HYDROCHLORIDE", "strength": ".31 mg/3mL"}], "application_number": "ANDA207625", "marketing_category": "ANDA", "marketing_start_date": "20161230", "listing_expiration_date": "20261231"}