Home NDC 25010-815 Timoptic
Product NDC 25010-815
11-digit product format 250100815
Labeler code 25010
Product ID 25010-815_0f32f82b-4e6e-4958-9124-f97451ae3e20
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Timolol Maleate
Dosage form SOLUTION
Route OPHTHALMIC
Labeler Aton Pharma, Inc.
Application NDA019463
Marketing category NDA
Marketing start 1986-11-05
Marketing end 0000-00-00
Substance TIMOLOL MALEATE
Active strength 5 mg/mL
NDC exclude flag E
Listing certified through 2017-12-31
Current FDA listing Historical FDA.report record 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 · 30 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 25010-815-66 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 25010-815-66 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 25010-815-66 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 25010-815-66 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 25010-815-66 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 25010-815-66 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 25010-815-66 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 25010-815-66 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 25010-815-66 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 25010-815-66 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 25010-815-66 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 25010-815-66 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 25010-815-66 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 25010-815-66 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product I Inactivated by FDA 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 25010-815-66 I Inactivated by FDA 110d247fa046…a55b01930146…
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.
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Timolol Maleate ACTIVE INGREDIENT P8Y54F701R TIMOPTIC (TIMOLOL MALEATE) SOLUTION [ATON PHARMA, INC.] 2 Timolol ACTIVE MOIETY 817W3C6175 TIMOPTIC (TIMOLOL MALEATE) SOLUTION [ATON PHARMA, INC.] 2 Sodium Hydroxide INACTIVE INGREDIENT 55X04QC32I TIMOPTIC (TIMOLOL MALEATE) SOLUTION [ATON PHARMA, INC.] 2 Sodium Phosphate, Dibasic INACTIVE INGREDIENT GR686LBA74 TIMOPTIC (TIMOLOL MALEATE) SOLUTION [ATON PHARMA, INC.] 2 Sodium Phosphate, Monobasic INACTIVE INGREDIENT 3980JIH2SW TIMOPTIC (TIMOLOL MALEATE) SOLUTION [ATON PHARMA, INC.] 2 Water INACTIVE INGREDIENT 059QF0KO0R TIMOPTIC (TIMOLOL MALEATE) SOLUTION [ATON PHARMA, INC.] 2
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.