Timolol Maleate

Product NDC
63629-7167
Requested package NDC
63629-7167-4
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63629-716763629-7167-4DDiscontinued by firm2026-08-17

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 dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A072668-001TIMOLOL MALEATETIMOLOL MALEATE20MGTABLET / ORAL1990-06-08
A072668-002TIMOLOL MALEATETIMOLOL MALEATE5MGTABLET / ORAL1990-06-08
A072668-003TIMOLOL MALEATETIMOLOL MALEATE10MGTABLET / ORALAB1990-06-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A072668-003AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A072668-001TIMOLOL MALEATE20MGTABLET / ORAL1990-06-08caaa826d4ba7…
2026-08-18 06:07:402026-07A072668-002TIMOLOL MALEATE5MGTABLET / ORAL1990-06-08caaa826d4ba7…
2026-08-18 06:07:402026-07A072668-003TIMOLOL MALEATE10MGTABLET / ORALAB1990-06-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A072668-001TIMOLOL MALEATE20MGTABLET / ORALABRS1990-06-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A072668-002TIMOLOL MALEATE5MGTABLET / ORALAB1990-06-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A072668-003TIMOLOL MALEATE10MGTABLET / ORALAB1990-06-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A072668-001TIMOLOL MALEATE20MGTABLET / ORALABRS1990-06-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A072668-002TIMOLOL MALEATE5MGTABLET / ORALAB1990-06-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A072668-003TIMOLOL MALEATE10MGTABLET / ORALAB1990-06-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A072668-001TIMOLOL MALEATE20MGTABLET / ORALABRS1990-06-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A072668-002TIMOLOL MALEATE5MGTABLET / ORALAB1990-06-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A072668-003TIMOLOL MALEATE10MGTABLET / ORALAB1990-06-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A072668-001TIMOLOL MALEATE20MGTABLET / ORALABRS1990-06-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A072668-002TIMOLOL MALEATE5MGTABLET / ORALAB1990-06-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A072668-003TIMOLOL MALEATE10MGTABLET / ORALAB1990-06-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A072668-001TIMOLOL MALEATE20MGTABLET / ORALABRS1990-06-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A072668-002TIMOLOL MALEATE5MGTABLET / ORALAB1990-06-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A072668-003TIMOLOL MALEATE10MGTABLET / ORALAB1990-06-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A072668-001TIMOLOL MALEATE20MGTABLET / ORALABRS1990-06-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A072668-002TIMOLOL MALEATE5MGTABLET / ORALAB1990-06-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A072668-003TIMOLOL MALEATE10MGTABLET / ORALAB1990-06-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A072668-001TIMOLOL MALEATE20MGTABLET / ORALABRS1990-06-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A072668-002TIMOLOL MALEATE5MGTABLET / ORALAB1990-06-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A072668-003TIMOLOL MALEATE10MGTABLET / ORALAB1990-06-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A072668-001TIMOLOL MALEATE20MGTABLET / ORALABRS1990-06-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A072668-002TIMOLOL MALEATE5MGTABLET / ORALAB1990-06-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A072668-003TIMOLOL MALEATE10MGTABLET / ORALAB1990-06-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A072668-001TIMOLOL MALEATE20MGTABLET / ORALABRS1990-06-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A072668-002TIMOLOL MALEATE5MGTABLET / ORALAB1990-06-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A072668-003TIMOLOL MALEATE10MGTABLET / ORALAB1990-06-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A072668-001TIMOLOL MALEATE20MGTABLET / ORALABRS1990-06-08d06236e962d9…
2024-10-29 15:01 UTC2024-10A072668-002TIMOLOL MALEATE5MGTABLET / ORALAB1990-06-08d06236e962d9…
2024-10-29 15:01 UTC2024-10A072668-003TIMOLOL MALEATE10MGTABLET / ORALAB1990-06-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A072668-001TIMOLOL MALEATE20MGTABLET / ORALABRS1990-06-0879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A072668-002TIMOLOL MALEATE5MGTABLET / ORALAB1990-06-0879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A072668-003TIMOLOL MALEATE10MGTABLET / ORALAB1990-06-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A072668-001TIMOLOL MALEATE20MGTABLET / ORALABRS1990-06-08301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A072668-002TIMOLOL MALEATE5MGTABLET / ORALAB1990-06-08301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A072668-003TIMOLOL MALEATE10MGTABLET / ORALAB1990-06-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A072668-001TIMOLOL MALEATE20MGTABLET / ORALABRS1990-06-081e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 122 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A072668-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A072668-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A072668-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A072668-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A072668-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A072668-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A072668-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A072668-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A072668-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A072668-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A072668-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A072668-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A072668-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A072668-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A072668-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A072668-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A072668-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A072668-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A072668-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A072668-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A072668-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A072668-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A072668-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A072668-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A072668-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A072668-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A072668-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A072668-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A072668-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A072668-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A072668-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A072668-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A072668-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A072668-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A072668-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A072668-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A072668-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A072668-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A072668-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A072668-003AB11e350fbaab3a…

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Timolol MaleateTIMOLOL MALEATEMylan Pharmaceuticals Inc.57c62928-63d8-4505-9b9e-c085a3a12c952020-07-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072668
application number: ANDA072668

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-7167-463629716704180 TABLET in 1 BOTTLE (63629-7167-4) 180 tablet2016-12-280000-00-00NoNoCurrent