Home NDC 24208-499 Timoptic in Ocudose
Product NDC 24208-499
11-digit product format 242080499
Labeler code 24208
Product ID 24208-499_fb4b627c-422c-471a-bcec-fff7187d79d7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Timolol Maleate
Dosage form SOLUTION
Route OPHTHALMIC
Labeler Bausch & Lomb Incorporated
Application NDA019463
Marketing category NDA
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 43 .
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 · 86 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 2026-09-14 22:38:34 2026-08 N019463-001 TIMOPTIC IN OCUDOSE EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT3 RLD, RS 1986-11-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N019463-002 TIMOPTIC IN OCUDOSE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT3 RLD, RS 1986-11-05 84e616aacf4f…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 73 observed states.
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 Timoptic in Ocudose
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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1922876 Internal RxNorm lookup 1922877 Internal RxNorm lookup 1922894 Internal RxNorm lookup 1922895 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 24208-499-00 Timoptic in Ocudose 1 in 1 CARTON SOLUTION 1 2 24208-499-00 Timoptic in Ocudose 10 in 1 POUCH SOLUTION 10 2 24208-499-68 Timoptic in Ocudose 10 in 1 POUCH SOLUTION 10 2 24208-499-68 Timoptic in Ocudose 6 in 1 CARTON SOLUTION 6 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 24208-499 TIMOPTIC IN OCUDOSE (TIMOLOL MALEATE) SOLUTION [BAUSCH & LOMB INCORPORATED] 2 Current NDC, Legacy NDC, 4 package rows 20220222_d130f0ec-c3b5-4bc3-8f4a-68fd6c3ec0cf.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 24208-499-00 24208049900 1 POUCH in 1 CARTON (24208-499-00) / 10 CONTAINER in 1 POUCH / .3 mL in 1 CONTAINER 1 pouch 2022-02-17 0000-00-00 Yes No Current 24208-499-68 24208049968 6 POUCH in 1 CARTON (24208-499-68) / 10 CONTAINER in 1 POUCH / .3 mL in 1 CONTAINER 6 pouch 2022-02-17 0000-00-00 No No Current