Home NDC 68669-525 Betimol
Product NDC 68669-525
11-digit product format 686690525
Labeler code 68669
Product ID 68669-525_d3344ae3-17c8-47d4-988b-e872240bffcf
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name timolol
Dosage form SOLUTION
Route OPHTHALMIC
Labeler Vistakon Pharmaceuticals LLC
Application NDA020439
Marketing category NDA
Marketing start 2000-10-01
Marketing end 0000-00-00
Substance TIMOLOL
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 2 · 110 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 68669-525-10 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 68669-525-99 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 68669-525-15 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 68669-525-05 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 68669-525-99 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 68669-525-05 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 68669-525-10 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 68669-525-15 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 68669-525-99 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 68669-525-05 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 68669-525-10 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 68669-525-15 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 68669-525-99 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 68669-525-05 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 68669-525-10 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 68669-525-15 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 68669-525-99 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 68669-525-05 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 68669-525-10 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 68669-525-15 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 68669-525-99 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 68669-525-05 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 68669-525-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 68669-525-15 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 68669-525-99 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 68669-525-05 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 68669-525-10 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 68669-525-15 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 68669-525-99 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 68669-525-05 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 68669-525-10 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 68669-525-15 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 68669-525-99 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 68669-525-05 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 68669-525-10 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 68669-525-15 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 68669-525-99 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 68669-525-05 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 68669-525-10 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 68669-525-15 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 68669-525-99 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 68669-525-05 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 68669-525-10 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 68669-525-15 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 68669-525-99 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 68669-525-05 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 68669-525-10 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 68669-525-15 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N020439-001 BETIMOL TIMOLOL 0.25% SOLUTION/DROPS / OPHTHALMIC RLD 1995-03-31 N020439-002 BETIMOL TIMOLOL 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1995-03-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N020439-002 AT
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 · 82 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 2026-02-19 14:30 UTC 2026-02 N020439-001 BETIMOL 0.25% SOLUTION/DROPS / OPHTHALMIC RLD 1995-03-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020439-002 BETIMOL 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1995-03-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020439-001 BETIMOL 0.25% SOLUTION/DROPS / OPHTHALMIC RLD 1995-03-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020439-002 BETIMOL 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1995-03-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020439-001 BETIMOL 0.25% SOLUTION/DROPS / OPHTHALMIC RLD 1995-03-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020439-002 BETIMOL 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1995-03-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020439-001 BETIMOL 0.25% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1995-03-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020439-002 BETIMOL 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1995-03-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020439-001 BETIMOL 0.25% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1995-03-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020439-002 BETIMOL 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1995-03-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020439-001 BETIMOL 0.25% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1995-03-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020439-002 BETIMOL 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1995-03-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020439-001 BETIMOL 0.25% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1995-03-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020439-002 BETIMOL 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1995-03-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020439-001 BETIMOL EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 1995-03-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020439-002 BETIMOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 1995-03-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020439-001 BETIMOL 0.25% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1995-03-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020439-002 BETIMOL 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1995-03-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020439-001 BETIMOL EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 1995-03-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020439-002 BETIMOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 1995-03-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020439-001 BETIMOL EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 1995-03-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020439-002 BETIMOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 1995-03-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020439-001 BETIMOL EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 1995-03-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020439-002 BETIMOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 1995-03-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020439-001 BETIMOL EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 1995-03-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020439-002 BETIMOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 1995-03-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020439-001 BETIMOL EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 1995-03-31 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N020439-002 BETIMOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 1995-03-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020439-001 BETIMOL EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1995-03-31 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020439-002 BETIMOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1995-03-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020439-001 BETIMOL EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1995-03-31 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N020439-002 BETIMOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1995-03-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020439-001 BETIMOL EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1995-03-31 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N020439-002 BETIMOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1995-03-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020439-001 BETIMOL EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1995-03-31 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020439-002 BETIMOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1995-03-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020439-001 BETIMOL EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1995-03-31 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N020439-002 BETIMOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1995-03-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020439-001 BETIMOL EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1995-03-31 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N020439-002 BETIMOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1995-03-31 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 45 observed states.
FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 68669-525-05 2025-11-22 BETIMOL ® (timolol ophthalmic solution) 0.25%, 0.5% 68669-525-10 2025-11-22 BETIMOL ® (timolol ophthalmic solution) 0.25%, 0.5% 68669-525-15 2025-11-22 BETIMOL ® (timolol ophthalmic solution) 0.25%, 0.5% 68669-525-99 2025-11-22 BETIMOL ® (timolol ophthalmic solution) 0.25%, 0.5% 68669-525-05 2019-10-21 BETIMOL ® (timolol ophthalmic solution) 0.25%, 0.5% 68669-525-10 2019-10-21 BETIMOL ® (timolol ophthalmic solution) 0.25%, 0.5% 68669-525-15 2019-10-21 BETIMOL ® (timolol ophthalmic solution) 0.25%, 0.5% 68669-525-99 2019-10-21 BETIMOL ® (timolol ophthalmic solution) 0.25%, 0.5%
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68669-525 BETIMOL (TIMOLOL) SOLUTION [VISTAKON PHARMACEUTICALS LLC] 3 Legacy NDC 20100429_00f62dd1-dad2-4892-8a5d-21e5e54509ce.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 · 1 matching rows.