Home NDC 63629-7167-3 Timolol Maleate
Product NDC 63629-7167
Requested package NDC 63629-7167-3
11-digit product format 636297167
Labeler code 63629
Product ID 63629-7167_69a4cc77-d427-483c-8e7f-bf8848f0d135
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name timolol maleate
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA072668
Marketing category ANDA
Marketing start 1990-06-08
Marketing end 0000-00-00
Substance TIMOLOL MALEATE
Active strength 10 mg/1
Pharmacologic classes Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC exclude flag No
Listing certified through 2021-12-31
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 · 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 42 .
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 A072668-001 TIMOLOL MALEATE TIMOLOL MALEATE 20MG TABLET / ORAL 1990-06-08 A072668-002 TIMOLOL MALEATE TIMOLOL MALEATE 5MG TABLET / ORAL 1990-06-08 A072668-003 TIMOLOL MALEATE TIMOLOL MALEATE 10MG TABLET / ORAL AB 1990-06-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A072668-003 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 · 126 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 A072668-001 TIMOLOL MALEATE 20MG TABLET / ORAL 1990-06-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A072668-002 TIMOLOL MALEATE 5MG TABLET / ORAL 1990-06-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A072668-003 TIMOLOL MALEATE 10MG TABLET / ORAL AB 1990-06-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A072668-001 TIMOLOL MALEATE 20MG TABLET / ORAL AB RS 1990-06-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A072668-002 TIMOLOL MALEATE 5MG TABLET / ORAL AB 1990-06-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A072668-003 TIMOLOL MALEATE 10MG TABLET / ORAL AB 1990-06-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A072668-001 TIMOLOL MALEATE 20MG TABLET / ORAL AB RS 1990-06-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A072668-002 TIMOLOL MALEATE 5MG TABLET / ORAL AB 1990-06-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A072668-003 TIMOLOL MALEATE 10MG TABLET / ORAL AB 1990-06-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A072668-001 TIMOLOL MALEATE 20MG TABLET / ORAL AB RS 1990-06-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A072668-002 TIMOLOL MALEATE 5MG TABLET / ORAL AB 1990-06-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A072668-003 TIMOLOL MALEATE 10MG TABLET / ORAL AB 1990-06-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A072668-001 TIMOLOL MALEATE 20MG TABLET / ORAL AB RS 1990-06-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A072668-002 TIMOLOL MALEATE 5MG TABLET / ORAL AB 1990-06-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A072668-003 TIMOLOL MALEATE 10MG TABLET / ORAL AB 1990-06-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A072668-001 TIMOLOL MALEATE 20MG TABLET / ORAL AB RS 1990-06-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A072668-002 TIMOLOL MALEATE 5MG TABLET / ORAL AB 1990-06-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A072668-003 TIMOLOL MALEATE 10MG TABLET / ORAL AB 1990-06-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A072668-001 TIMOLOL MALEATE 20MG TABLET / ORAL AB RS 1990-06-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A072668-002 TIMOLOL MALEATE 5MG TABLET / ORAL AB 1990-06-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A072668-003 TIMOLOL MALEATE 10MG TABLET / ORAL AB 1990-06-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A072668-001 TIMOLOL MALEATE 20MG TABLET / ORAL AB RS 1990-06-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A072668-002 TIMOLOL MALEATE 5MG TABLET / ORAL AB 1990-06-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A072668-003 TIMOLOL MALEATE 10MG TABLET / ORAL AB 1990-06-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A072668-001 TIMOLOL MALEATE 20MG TABLET / ORAL AB RS 1990-06-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A072668-002 TIMOLOL MALEATE 5MG TABLET / ORAL AB 1990-06-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A072668-003 TIMOLOL MALEATE 10MG TABLET / ORAL AB 1990-06-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A072668-001 TIMOLOL MALEATE 20MG TABLET / ORAL AB RS 1990-06-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A072668-002 TIMOLOL MALEATE 5MG TABLET / ORAL AB 1990-06-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A072668-003 TIMOLOL MALEATE 10MG TABLET / ORAL AB 1990-06-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A072668-001 TIMOLOL MALEATE 20MG TABLET / ORAL AB RS 1990-06-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A072668-002 TIMOLOL MALEATE 5MG TABLET / ORAL AB 1990-06-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A072668-003 TIMOLOL MALEATE 10MG TABLET / ORAL AB 1990-06-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A072668-001 TIMOLOL MALEATE 20MG TABLET / ORAL AB RS 1990-06-08 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A072668-002 TIMOLOL MALEATE 5MG TABLET / ORAL AB 1990-06-08 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A072668-003 TIMOLOL MALEATE 10MG TABLET / ORAL AB 1990-06-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A072668-001 TIMOLOL MALEATE 20MG TABLET / ORAL AB RS 1990-06-08 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A072668-002 TIMOLOL MALEATE 5MG TABLET / ORAL AB 1990-06-08 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A072668-003 TIMOLOL MALEATE 10MG TABLET / ORAL AB 1990-06-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A072668-001 TIMOLOL MALEATE 20MG TABLET / ORAL AB RS 1990-06-08 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 122 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 63629-7167-3 63629716703 18 TABLET in 1 BOTTLE (63629-7167-3) 18 tablet 2016-12-28 0000-00-00 No No Current