Home NDC 82667-021 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N218158-001 BYQLOVI CLOBETASOL PROPIONATE 0.05% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2024-03-04
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N218158-001 10588913 2036-05-09 Drug product 2024-04-01 N218158-001 11376262 2036-05-09 U-19 Drug product 2024-04-01
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N218158-001 NP 2027-03-04
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N218158-001 BYQLOVI 0.05% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2024-03-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218158-001 BYQLOVI 0.05% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2024-03-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N218158-001 BYQLOVI 0.05% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2024-03-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218158-001 CLOBETASOL PROPIONATE 0.05% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2024-03-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N218158-001 CLOBETASOL PROPIONATE 0.05% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2024-03-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N218158-001 CLOBETASOL PROPIONATE 0.05% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2024-03-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N218158-001 CLOBETASOL PROPIONATE 0.05% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2024-03-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N218158-001 CLOBETASOL PROPIONATE 0.05% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2024-03-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N218158-001 CLOBETASOL PROPIONATE 0.05% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2024-03-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N218158-001 CLOBETASOL PROPIONATE 0.05% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2024-03-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N218158-001 CLOBETASOL PROPIONATE 0.05% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2024-03-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N218158-001 CLOBETASOL PROPIONATE 0.05% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2024-03-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N218158-001 CLOBETASOL PROPIONATE 0.05% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2024-03-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N218158-001 CLOBETASOL PROPIONATE 0.05% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2024-03-04 8072bd15b7f6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N218158-001 BYQLOVI 0.05% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2024-03-04 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N218158-001 10588913 2036-05-09 Drug product 2024-04-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218158-001 11376262 2036-05-09 U-19 Drug product 2024-04-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218158-001 10588913 2036-05-09 Drug product 2024-04-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218158-001 11376262 2036-05-09 U-19 Drug product 2024-04-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N218158-001 10588913 2036-05-09 Drug product 2024-04-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N218158-001 11376262 2036-05-09 U-19 Drug product 2024-04-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218158-001 10588913 2036-05-09 Drug product 2024-04-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218158-001 11376262 2036-05-09 U-19 Drug product 2024-04-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N218158-001 10588913 2036-05-09 Drug product 2024-04-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N218158-001 11376262 2036-05-09 U-19 Drug product 2024-04-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N218158-001 10588913 2036-05-09 Drug product 2024-04-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N218158-001 11376262 2036-05-09 U-19 Drug product 2024-04-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N218158-001 10588913 2036-05-09 Drug product 2024-04-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N218158-001 11376262 2036-05-09 U-19 Drug product 2024-04-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N218158-001 10588913 2036-05-09 Drug product 2024-04-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N218158-001 11376262 2036-05-09 U-19 Drug product 2024-04-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N218158-001 10588913 2036-05-09 Drug product 2024-04-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N218158-001 11376262 2036-05-09 U-19 Drug product 2024-04-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N218158-001 10588913 2036-05-09 Drug product 2024-04-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N218158-001 11376262 2036-05-09 U-19 Drug product 2024-04-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N218158-001 10588913 2036-05-09 Drug product 2024-04-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N218158-001 11376262 2036-05-09 U-19 Drug product 2024-04-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N218158-001 10588913 2036-05-09 Drug product 2024-04-01 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N218158-001 11376262 2036-05-09 U-19 Drug product 2024-04-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N218158-001 10588913 2036-05-09 Drug product 2024-04-01 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N218158-001 11376262 2036-05-09 U-19 Drug product 2024-04-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N218158-001 10588913 2036-05-09 Drug product 2024-04-01 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N218158-001 11376262 2036-05-09 U-19 Drug product 2024-04-01 8072bd15b7f6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N218158-001 10588913 2036-05-09 Drug product 2024-04-01 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N218158-001 11376262 2036-05-09 U-19 Drug product 2024-04-01 a50c72e98297…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base BYQLOVI
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CLOBETASOL PROPIONATE .5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 779619577M Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2683740 Internal RxNorm lookup 2733663 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 82667-021-00 BYQLOVI 1 in 1 CARTON FOR SUSPENSION 1 3 82667-021-00 BYQLOVI 3.5 mL in 1 BOTTLE, PLASTIC FOR SUSPENSION 3.5 3 82667-021-05 BYQLOVI 1 in 1 CARTON FOR SUSPENSION 1 3 82667-021-05 BYQLOVI 3.5 mL in 1 BOTTLE, PLASTIC FOR SUSPENSION 3.5 3
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 82667-021-00 82667002100 1 BOTTLE, PLASTIC in 1 CARTON (82667-021-00) / 3.5 mL in 1 BOTTLE, PLASTIC 2026-01-25 Yes No Current 82667-021-05 82667002105 1 BOTTLE, PLASTIC in 1 CARTON (82667-021-05) / 3.5 mL in 1 BOTTLE, PLASTIC 2026-01-25 No No Current