BYQLOVI

Product NDC
82667-021
11-digit product format
826670021
Labeler code
82667
Product ID
82667-021_494dc96c-0519-0b10-e063-6294a90ae904
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clobetasol propionate
Dosage form
FOR SUSPENSION
Route
OPHTHALMIC
Labeler
Harrow Eye, LLC
Application
NDA218158
Marketing category
NDA
Marketing start
2024-03-04
Substance
CLOBETASOL PROPIONATE
Active strength
.5 mg/mL
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
BYQLOVI
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOBETASOL PROPIONATE.5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii779619577M
Rxcui2683740, 2733663

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
20abe2c3-3e80-d2b2-39eb-3156e4af4799Product name320250124
45ad92f8-d116-4c0c-851c-2e740b7d8e6fProduct name120250122
42be0ad5-6fd7-4f1b-8108-6d9dd7d571dfProduct name720250107
3813b789-94b9-edd6-f010-6b926dd462e5Product name520230113
30eee8a1-850e-41ed-b5ab-761301aeab49Product name620221206
18e5b6f7-c414-b1f1-b684-17fdd02c215eProduct name420210927
1c87bbde-dd91-a122-db33-67ae814cb645Product name720210510
519b5875-7d7d-4aa6-9d3d-470fa1376595Product name420200227
98669154-3e9c-47da-8a2c-656ab71848beProduct name220180607
8d4f8539-436f-453b-8b76-5322d403fc8eProduct name120180131
837ac3c6-ee71-c5a6-6eba-c4065f37e9f5Product name220171010

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82667-021-00BYQLOVI1 in 1 CARTONFOR SUSPENSION13
82667-021-00BYQLOVI3.5 mL in 1 BOTTLE, PLASTICFOR SUSPENSION3.53
82667-021-05BYQLOVI1 in 1 CARTONFOR SUSPENSION13
82667-021-05BYQLOVI3.5 mL in 1 BOTTLE, PLASTICFOR SUSPENSION3.53

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82667-021-05ML - Milliliter82667-02196b396f2-8274-405a-805c-5fefd611cebb12026-04-20

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2733663BYQLOVI 0.05 % Ophthalmic SuspensionPSN31ca5a0f-812e-491d-aa00-d8ed424ba3223
2683740clobetasol propionate 0.05 % Ophthalmic SuspensionPSN31ca5a0f-812e-491d-aa00-d8ed424ba3223
2733663clobetasol propionate 0.5 MG/ML Ophthalmic Suspension [Byqlovi]SBD31ca5a0f-812e-491d-aa00-d8ed424ba3223
2683740clobetasol propionate 0.5 MG/ML Ophthalmic SuspensionSCD31ca5a0f-812e-491d-aa00-d8ed424ba3223
2733663Byqlovi 0.05 % Ophthalmic SuspensionSY31ca5a0f-812e-491d-aa00-d8ed424ba3223
2683740clobetasol propionate 0.05 % Ophthalmic SuspensionSY31ca5a0f-812e-491d-aa00-d8ed424ba3223

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
82667-021-00826670021001 BOTTLE, PLASTIC in 1 CARTON (82667-021-00) / 3.5 mL in 1 BOTTLE, PLASTIC2026-01-25YesNoHistorical
82667-021-05826670021051 BOTTLE, PLASTIC in 1 CARTON (82667-021-05) / 3.5 mL in 1 BOTTLE, PLASTIC2026-01-25NoNoHistorical