Home NDC 81046-0319 CLOBETASOL PROPIONATE
Product NDC 81046-0319
11-digit product format 810460319
Labeler code 81046
Product ID 81046-0319_32e1b12d-ed8c-33a3-e063-6294a90a3109
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name CLOBETASOL PROPIONATE
Dosage form SUSPENSION/ DROPS
Route OPHTHALMIC
Labeler Eyenovia, Inc.
Application NDA218158
Marketing category NDA
Marketing start 2024-03-25
Substance CLOBETASOL PROPIONATE
Active strength .5 mg/mL
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 81046-0319 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 81046-0319 81046-0319-1 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip 8af77b9d5b6f…d9bbb34c5368…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 2026-09-14 22:38:34 2026-08 N218158-001 BYQLOVI 0.05% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2024-03-04 84e616aacf4f…2026-08-18 06:07:40 2026-07 N218158-001 BYQLOVI 0.05% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2024-03-04 caaa826d4ba7…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 2026-09-14 22:38:34 2026-08 N218158-001 10588913 2036-05-09 Drug product 2024-04-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218158-001 11376262 2036-05-09 U-19 Drug product 2024-04-01 84e616aacf4f…2026-08-18 06:07:40 2026-07 N218158-001 10588913 2036-05-09 Drug product 2024-04-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218158-001 11376262 2036-05-09 U-19 Drug product 2024-04-01 caaa826d4ba7…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# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base CLOBETASOL PROPIONATE
Listing expiration 2026-12-31 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2683740 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 81046-0319-1 CLOBETASOL PROPIONATE 1 in 1 CARTON SUSPENSION/ DROPS 1 3 81046-0319-1 CLOBETASOL PROPIONATE 3.5 mL in 1 BOTTLE, DROPPER SUSPENSION/ DROPS 3.5 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 81046-0319 CLOBETASOL PROPIONATE SUSPENSION/ DROPS [EYENOVIA, INC.] 3 Current NDC, 2 package rows 20250418_7687c980-7006-4222-80b9-c32773772d3e.zip
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 81046-0319-1 81046031901 1 BOTTLE, DROPPER in 1 CARTON (81046-0319-1) / 3.5 mL in 1 BOTTLE, DROPPER 2024-03-25 No No Current