Home NDC 13811-620-10 Timolol Maleate
Product NDC 13811-620
Requested package NDC 13811-620-10
11-digit product format 138110620
Labeler code 13811
Product ID 13811-620_b9e5df0e-06d1-6f72-e053-2995a90a2d07
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Timolol Maleate
Dosage form TABLET
Route ORAL
Labeler TRIGEN LABORATORIES, LLC
Application ANDA207556
Marketing category ANDA
Marketing start 2019-05-06
Marketing end 2021-11-30
Substance TIMOLOL MALEATE
Active strength 20 mg/1
Pharmacologic classes Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC exclude flag No
Listing certified through 0000-00-00
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A207556-001 TIMOLOL MALEATE TIMOLOL MALEATE 5MG TABLET / ORAL 2019-05-02 A207556-002 TIMOLOL MALEATE TIMOLOL MALEATE 10MG TABLET / ORAL AB 2019-05-02 A207556-003 TIMOLOL MALEATE TIMOLOL MALEATE 20MG TABLET / ORAL RS 2019-05-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A207556-002 AB
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 4 · 123 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 A207556-001 TIMOLOL MALEATE 5MG TABLET / ORAL AB 2019-05-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207556-002 TIMOLOL MALEATE 10MG TABLET / ORAL AB 2019-05-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207556-003 TIMOLOL MALEATE 20MG TABLET / ORAL AB 2019-05-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207556-001 TIMOLOL MALEATE 5MG TABLET / ORAL AB 2019-05-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207556-002 TIMOLOL MALEATE 10MG TABLET / ORAL AB 2019-05-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207556-003 TIMOLOL MALEATE 20MG TABLET / ORAL AB 2019-05-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207556-001 TIMOLOL MALEATE 5MG TABLET / ORAL AB 2019-05-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207556-002 TIMOLOL MALEATE 10MG TABLET / ORAL AB 2019-05-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207556-003 TIMOLOL MALEATE 20MG TABLET / ORAL AB 2019-05-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207556-001 TIMOLOL MALEATE 5MG TABLET / ORAL AB 2019-05-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207556-002 TIMOLOL MALEATE 10MG TABLET / ORAL AB 2019-05-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207556-003 TIMOLOL MALEATE 20MG TABLET / ORAL AB 2019-05-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207556-001 TIMOLOL MALEATE 5MG TABLET / ORAL AB 2019-05-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207556-002 TIMOLOL MALEATE 10MG TABLET / ORAL AB 2019-05-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207556-003 TIMOLOL MALEATE 20MG TABLET / ORAL AB 2019-05-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207556-001 TIMOLOL MALEATE 5MG TABLET / ORAL AB 2019-05-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207556-002 TIMOLOL MALEATE 10MG TABLET / ORAL AB 2019-05-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207556-003 TIMOLOL MALEATE 20MG TABLET / ORAL AB 2019-05-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207556-001 TIMOLOL MALEATE 5MG TABLET / ORAL AB 2019-05-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207556-002 TIMOLOL MALEATE 10MG TABLET / ORAL AB 2019-05-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207556-003 TIMOLOL MALEATE 20MG TABLET / ORAL AB 2019-05-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207556-001 TIMOLOL MALEATE 5MG TABLET / ORAL AB 2019-05-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207556-002 TIMOLOL MALEATE 10MG TABLET / ORAL AB 2019-05-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207556-003 TIMOLOL MALEATE 20MG TABLET / ORAL AB 2019-05-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207556-001 TIMOLOL MALEATE 5MG TABLET / ORAL AB 2019-05-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207556-002 TIMOLOL MALEATE 10MG TABLET / ORAL AB 2019-05-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207556-003 TIMOLOL MALEATE 20MG TABLET / ORAL AB 2019-05-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207556-001 TIMOLOL MALEATE 5MG TABLET / ORAL AB 2019-05-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207556-002 TIMOLOL MALEATE 10MG TABLET / ORAL AB 2019-05-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207556-003 TIMOLOL MALEATE 20MG TABLET / ORAL AB 2019-05-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207556-001 TIMOLOL MALEATE 5MG TABLET / ORAL AB 2019-05-02 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207556-002 TIMOLOL MALEATE 10MG TABLET / ORAL AB 2019-05-02 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207556-003 TIMOLOL MALEATE 20MG TABLET / ORAL AB 2019-05-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207556-001 TIMOLOL MALEATE 5MG TABLET / ORAL AB 2019-05-02 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207556-002 TIMOLOL MALEATE 10MG TABLET / ORAL AB 2019-05-02 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207556-003 TIMOLOL MALEATE 20MG TABLET / ORAL AB 2019-05-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207556-001 TIMOLOL MALEATE 5MG TABLET / ORAL AB 2019-05-02 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207556-002 TIMOLOL MALEATE 10MG TABLET / ORAL AB 2019-05-02 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207556-003 TIMOLOL MALEATE 20MG TABLET / ORAL AB 2019-05-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207556-001 TIMOLOL MALEATE 5MG TABLET / ORAL AB 2019-05-02 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 121 observed states.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 13811-620-10 13811062010 100 TABLET in 1 BOTTLE (13811-620-10) 100 tablet 2019-05-06 2021-11-30 No No Current