Home NDC 82260-496 Timolol Maleate
Product NDC 82260-496
11-digit product format 822600496
Labeler code 82260
Product ID 82260-496_2f9f1dcc-6988-edb0-e063-6394a90ac484
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Timolol Maleate
Dosage form SOLUTION
Route OPHTHALMIC
Labeler Bausch & Lomb Americas Inc.
Application NDA019463
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2022-02-17
Substance TIMOLOL MALEATE
Active strength 6.8 mg/mL
Pharmacologic classes Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N019463-001 TIMOPTIC IN OCUDOSE TIMOLOL MALEATE EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT3 RLD, RS 1986-11-05 N019463-002 TIMOPTIC IN OCUDOSE TIMOLOL MALEATE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT3 RLD, RS 1986-11-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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.
Product history page 1 of 3 · 84 observed 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 2026-08-18 06:07:40 2026-07 N019463-001 TIMOPTIC IN OCUDOSE EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT3 RLD, RS 1986-11-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019463-002 TIMOPTIC IN OCUDOSE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT3 RLD, RS 1986-11-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N019463-001 TIMOPTIC IN OCUDOSE EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT3 RLD, RS 1986-11-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019463-002 TIMOPTIC IN OCUDOSE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT3 RLD, RS 1986-11-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019463-001 TIMOPTIC IN OCUDOSE EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT3 RLD, RS 1986-11-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019463-002 TIMOPTIC IN OCUDOSE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT3 RLD, RS 1986-11-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019463-001 TIMOPTIC IN OCUDOSE EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT3 RLD, RS 1986-11-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019463-002 TIMOPTIC IN OCUDOSE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT3 RLD, RS 1986-11-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019463-001 TIMOPTIC IN OCUDOSE EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT3 RLD, RS 1986-11-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019463-002 TIMOPTIC IN OCUDOSE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT3 RLD, RS 1986-11-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019463-001 TIMOPTIC IN OCUDOSE EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT3 RLD, RS 1986-11-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019463-002 TIMOPTIC IN OCUDOSE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT3 RLD, RS 1986-11-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019463-001 TIMOPTIC IN OCUDOSE EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT3 RLD, RS 1986-11-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019463-002 TIMOPTIC IN OCUDOSE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT3 RLD, RS 1986-11-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019463-001 TIMOPTIC IN OCUDOSE EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT3 RLD, RS 1986-11-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019463-002 TIMOPTIC IN OCUDOSE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT3 RLD, RS 1986-11-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019463-001 TIMOPTIC IN OCUDOSE EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT3 RLD, RS 1986-11-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019463-002 TIMOPTIC IN OCUDOSE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT3 RLD, RS 1986-11-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019463-001 TIMOPTIC IN OCUDOSE EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT3 RLD, RS 1986-11-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019463-002 TIMOPTIC IN OCUDOSE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT3 RLD, RS 1986-11-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019463-001 TIMOPTIC IN OCUDOSE EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT3 RLD, RS 1986-11-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N019463-002 TIMOPTIC IN OCUDOSE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT3 RLD, RS 1986-11-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019463-001 TIMOPTIC IN OCUDOSE EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT3 RLD, RS 1986-11-05 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019463-002 TIMOPTIC IN OCUDOSE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT3 RLD, RS 1986-11-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019463-001 TIMOPTIC IN OCUDOSE EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT3 RLD, RS 1986-11-05 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019463-002 TIMOPTIC IN OCUDOSE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT3 RLD, RS 1986-11-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019463-001 TIMOPTIC IN OCUDOSE EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT3 RLD, RS 1986-11-05 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019463-002 TIMOPTIC IN OCUDOSE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT3 RLD, RS 1986-11-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N019463-001 TIMOPTIC IN OCUDOSE EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT3 RLD, RS 1986-11-05 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N019463-002 TIMOPTIC IN OCUDOSE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT3 RLD, RS 1986-11-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019463-001 TIMOPTIC IN OCUDOSE EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT3 RLD, RS 1986-11-05 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019463-002 TIMOPTIC IN OCUDOSE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT3 RLD, RS 1986-11-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N019463-001 TIMOPTIC IN OCUDOSE EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT3 RLD, RS 1986-11-05 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N019463-002 TIMOPTIC IN OCUDOSE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT3 RLD, RS 1986-11-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N019463-001 TIMOPTIC IN OCUDOSE EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT3 RLD, RS 1986-11-05 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N019463-002 TIMOPTIC IN OCUDOSE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT3 RLD, RS 1986-11-05 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N019463-001 TIMOPTIC IN OCUDOSE EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 1986-11-05 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N019463-002 TIMOPTIC IN OCUDOSE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 1986-11-05 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N019463-001 TIMOPTIC IN OCUDOSE EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT3 RLD, RS 1986-11-05 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N019463-002 TIMOPTIC IN OCUDOSE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT3 RLD, RS 1986-11-05 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 71 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Timolol Maleate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TIMOLOL MALEATE 6.8 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination P8Y54F701R Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1922894 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 82260-496-05 Timolol Maleate 10 in 1 POUCH SOLUTION 10 3 82260-496-05 Timolol Maleate 6 in 1 CARTON SOLUTION 6 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82260-496 TIMOLOL MALEATE SOLUTION [BAUSCH & LOMB AMERICAS INC.] 3 Current NDC, Legacy NDC, 2 package rows 20250308_036dc753-1698-4c69-9bcf-752c7061203c.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 Units Marketing start Marketing end Sample Exclude flag Status 82260-496-05 82260049605 6 POUCH in 1 CARTON (82260-496-05) / 10 CONTAINER in 1 POUCH / .3 mL in 1 CONTAINER 6 pouch 2022-02-17 0000-00-00 No No Current