byqlovi

Generic: clobetasol propionate

Labeler: harrow eye, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name byqlovi
Generic Name clobetasol propionate
Labeler harrow eye, llc
Dosage Form FOR SUSPENSION
Routes
OPHTHALMIC
Active Ingredients

clobetasol propionate .5 mg/mL

Manufacturer
Harrow Eye, LLC

Identifiers & Regulatory

Product NDC 82667-021
Product ID 82667-021_494dc96c-0519-0b10-e063-6294a90ae904
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA218158
Listing Expiration 2027-12-31
Marketing Start 2024-03-04

Pharmacologic Class

Classes
corticosteroid hormone receptor agonists [moa] corticosteroid [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82667021
Hyphenated Format 82667-021

Supplemental Identifiers

RxCUI
2683740 2733663
UPC
0382667021056
UNII
779619577M

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 byqlovi (source: ndc)
Generic Name clobetasol propionate (source: ndc)
Application Number NDA218158 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • .5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (82667-021-00) / 3.5 mL in 1 BOTTLE, PLASTIC
  • 1 BOTTLE, PLASTIC in 1 CARTON (82667-021-05) / 3.5 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (2)

82667-021-00 1 BOTTLE, PLASTIC in 1 CARTON (82667-021-00) / 3.5 mL in 1 BOTTLE, PLASTIC 82667-021-05 1 BOTTLE, PLASTIC in 1 CARTON (82667-021-05) / 3.5 mL in 1 BOTTLE, PLASTIC

Ingredients (1)

clobetasol propionate (.5 mg/mL)

Linked Drug Pages (1)

BYQLOVI ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "494dc96c-0519-0b10-e063-6294a90ae904", "openfda": {"upc": ["0382667021056"], "unii": ["779619577M"], "rxcui": ["2683740", "2733663"], "spl_set_id": ["31ca5a0f-812e-491d-aa00-d8ed424ba322"], "manufacturer_name": ["Harrow Eye, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "1 BOTTLE, PLASTIC in 1 CARTON (82667-021-00)  / 3.5 mL in 1 BOTTLE, PLASTIC", "package_ndc": "82667-021-00", "marketing_start_date": "20260125"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (82667-021-05)  / 3.5 mL in 1 BOTTLE, PLASTIC", "package_ndc": "82667-021-05", "marketing_start_date": "20260125"}], "brand_name": "BYQLOVI", "product_id": "82667-021_494dc96c-0519-0b10-e063-6294a90ae904", "dosage_form": "FOR SUSPENSION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "82667-021", "generic_name": "clobetasol propionate", "labeler_name": "Harrow Eye, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BYQLOVI", "active_ingredients": [{"name": "CLOBETASOL PROPIONATE", "strength": ".5 mg/mL"}], "application_number": "NDA218158", "marketing_category": "NDA", "marketing_start_date": "20240304", "listing_expiration_date": "20271231"}