Home NDC 0065-8596 BRYTLY
Product NDC 0065-8596
11-digit product format 000658596
Labeler code 0065
Product ID 0065-8596_11291732-f127-4857-9b74-4409975ac779
Type HUMAN OTC DRUG
Nonproprietary name Apraclonidine Hydrochloride
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Alcon Laboratories, Inc.
Application NDA220341
Marketing category NDA
Marketing start 2026-10-16
Substance APRACLONIDINE HYDROCHLORIDE
Active strength 1.25 mg/mL
Pharmacologic classes Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [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 45 .
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 N220341-001 BRYTLY APRACLONIDINE HYDROCHLORIDE EQ 0.125% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2026-10-16
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 2026-11-14 07:37:17 2026-10 N220341-001 BRYTLY EQ 0.125% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2026-10-16 d4dbc9d85df4…
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 BRYTLY
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength APRACLONIDINE HYDROCHLORIDE 1.25 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination D2VW67N38H Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2755183 Internal RxNorm lookup 2755188 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0065-8596-04 00065859604 1 BOTTLE in 1 CARTON (0065-8596-04) / 5 mL in 1 BOTTLE 1 bottle 2026-10-16 No No Current 0065-8596-05 00065859605 1 BOTTLE in 1 CARTON (0065-8596-05) / 2 mL in 1 BOTTLE 1 bottle 2026-10-16 No No Current 0065-8596-06 00065859606 1 BOTTLE in 1 CARTON (0065-8596-06) / .5 mL in 1 BOTTLE 1 bottle 2026-10-16 Yes No Current