Timoptic-XE

Product NDC
24208-814
11-digit product format
242080814
Labeler code
24208
Product ID
24208-814_cb6890c5-7788-453b-910d-10c2bee17d04
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Timolol Maleate
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Bausch & Lomb Incorporated
Application
NDA020330
Marketing category
NDA
Marketing start
2016-05-31
Substance
TIMOLOL MALEATE
Active strength
2.5 mg/mL
Pharmacologic classes
Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020330-001TIMOPTIC-XETIMOLOL MALEATEEQ 0.25% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICABRLD1993-11-04
N020330-002TIMOPTIC-XETIMOLOL MALEATEEQ 0.5% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICABRLD1993-11-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
N020330-001AB
N020330-002AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N020330-001TIMOPTIC-XEEQ 0.25% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICABRLD1993-11-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020330-002TIMOPTIC-XEEQ 0.5% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICABRLD1993-11-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020330-001TIMOPTIC-XEEQ 0.25% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICABRLD1993-11-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020330-002TIMOPTIC-XEEQ 0.5% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICABRLD1993-11-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08N020330-001TIMOPTIC-XEEQ 0.25% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICABRLD1993-11-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020330-002TIMOPTIC-XEEQ 0.5% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICABRLD1993-11-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020330-001TIMOPTIC-XEEQ 0.25% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICABRLD1993-11-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020330-002TIMOPTIC-XEEQ 0.5% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICABRLD1993-11-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020330-001TIMOPTIC-XEEQ 0.25% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICABRLD1993-11-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020330-002TIMOPTIC-XEEQ 0.5% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICABRLD1993-11-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020330-001TIMOPTIC-XEEQ 0.25% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICABRLD1993-11-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020330-002TIMOPTIC-XEEQ 0.5% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICABRLD1993-11-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020330-001TIMOPTIC-XEEQ 0.25% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICABRLD1993-11-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020330-002TIMOPTIC-XEEQ 0.5% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICABRLD1993-11-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020330-001TIMOPTIC-XEEQ 0.25% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICABRLD1993-11-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020330-002TIMOPTIC-XEEQ 0.5% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICABRLD1993-11-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020330-001TIMOPTIC-XEEQ 0.25% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICABRLD1993-11-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020330-002TIMOPTIC-XEEQ 0.5% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICABRLD1993-11-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020330-001TIMOPTIC-XEEQ 0.25% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICABRLD1993-11-04d06236e962d9…
2024-10-29 15:01 UTC2024-10N020330-002TIMOPTIC-XEEQ 0.5% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICABRLD1993-11-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020330-001TIMOPTIC-XEEQ 0.25% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICABRLD1993-11-0479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020330-002TIMOPTIC-XEEQ 0.5% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICABRLD1993-11-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020330-001TIMOPTIC-XEEQ 0.25% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICABRLD1993-11-04301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020330-002TIMOPTIC-XEEQ 0.5% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICABRLD1993-11-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020330-001TIMOPTIC-XEEQ 0.25% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICABRLD1993-11-041e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020330-002TIMOPTIC-XEEQ 0.5% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICABRLD1993-11-041e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020330-001TIMOPTIC-XEEQ 0.25% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICABRLD1993-11-048072bd15b7f6…
2024-05-31 18:47 UTC2024-05N020330-002TIMOPTIC-XEEQ 0.5% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICABRLD1993-11-048072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020330-001TIMOPTIC-XEEQ 0.25% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICABRLD1993-11-045c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020330-002TIMOPTIC-XEEQ 0.5% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICABRLD1993-11-045c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020330-001TIMOPTIC-XEEQ 0.25% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICABRLD1993-11-045d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N020330-002TIMOPTIC-XEEQ 0.5% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICABRLD1993-11-045d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020330-001TIMOPTIC-XEEQ 0.25% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICABRLD1993-11-044b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N020330-002TIMOPTIC-XEEQ 0.5% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICABRLD1993-11-044b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020330-001TIMOPTIC-XEEQ 0.25% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICABRLD, RS1993-11-0474a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020330-002TIMOPTIC-XEEQ 0.5% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICABRLD, RS1993-11-0474a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020330-001TIMOPTIC-XEEQ 0.25% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICABRLD1993-11-04bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N020330-002TIMOPTIC-XEEQ 0.5% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICABRLD1993-11-04bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020330-001TIMOPTIC-XEEQ 0.25% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICABRLD1993-11-04782e0a99824c…
2021-12-28 21:50 UTC2021-12N020330-002TIMOPTIC-XEEQ 0.5% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICABRLD1993-11-04782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N020330-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020330-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020330-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020330-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020330-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020330-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020330-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020330-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020330-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020330-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020330-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020330-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020330-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020330-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020330-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020330-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020330-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020330-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020330-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N020330-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020330-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020330-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020330-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020330-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020330-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020330-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020330-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N020330-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020330-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020330-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020330-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N020330-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020330-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N020330-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020330-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020330-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020330-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N020330-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020330-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12N020330-002AB1782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
Timoptic-XE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TIMOLOL MALEATE2.5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
P8Y54F701RInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
313407Internal RxNorm lookup
313408Internal RxNorm lookup
861420Internal RxNorm lookup
861422Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
a4d03de7-06b7-4cfc-9d1b-616969df209cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6c0c444-a6ba-2fb5-a7bc-7f0443fa5791Product name420251208
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
73103a56-9f57-4f32-a306-a42bfa2fea36Product name120250505
425025fc-f910-4afe-815b-58d4486ed4f7Product name420250331
26c5ddae-5c69-622d-e599-5fd583634968Product name420250313
ee780602-134c-4c60-a2f0-e973ba549cd4Product name220250304
03f77cb2-b4ad-3c11-8781-787b5ece4291Product name320240507
273981e4-09e7-45cc-967c-554f628ededfProduct name320230627
97dad5a2-c524-a7b5-dede-82edefe9ce62Product name720220929
d11e749b-f93e-0ce3-ceda-28fe03d8081dProduct name220190731

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24208-814-25Timoptic-XE1 in 1 CARTONSOLUTION111
24208-814-25Timoptic-XE5 mL in 1 BOTTLE, DISPENSINGSOLUTION511

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24208-814-25ML - Milliliter24208-814d5ef76c1-3819-4efb-b2a8-a58ec8f7c85212018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24208-814TIMOPTIC-XE (TIMOLOL MALEATE) SOLUTION [BAUSCH & LOMB INCORPORATED]11Current NDC, Legacy NDC, 2 package rows20220521_a4d03de7-06b7-4cfc-9d1b-616969df209c.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Timolol MaleateTIMOLOL MALEATEBausch & Lomb Americas Inc.581f80f7-4419-49e2-867d-40443c75409f2025-03-26Warnings, Adverse reactionsExact identifier
application applno (NDA): 020330
application number: NDA020330
Timoptic-XETIMOLOL MALEATEBausch & Lomb Incorporateda4d03de7-06b7-4cfc-9d1b-616969df209c2022-03-31Warnings, Adverse reactionsExact identifier
application applno (NDA): 020330
application number: NDA020330
ndc (product): 24208-814

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313407timolol maleate 0.25 % Ophthalmic Gel Forming SolutionPSNa4d03de7-06b7-4cfc-9d1b-616969df209c11
313408timolol maleate 0.5 % Ophthalmic Gel Forming SolutionPSNa4d03de7-06b7-4cfc-9d1b-616969df209c11
861420Timoptic-XE 0.25 % Ophthalmic Gel Forming SolutionPSNa4d03de7-06b7-4cfc-9d1b-616969df209c11
861422Timoptic-XE 0.5 % Ophthalmic Gel Forming SolutionPSNa4d03de7-06b7-4cfc-9d1b-616969df209c11
861420timolol 0.0025 MG/MG Ophthalmic Gel [Timoptic]SBDa4d03de7-06b7-4cfc-9d1b-616969df209c11
861422timolol 0.005 MG/MG Ophthalmic Gel [Timoptic]SBDa4d03de7-06b7-4cfc-9d1b-616969df209c11
313407timolol 0.0025 MG/MG Ophthalmic GelSCDa4d03de7-06b7-4cfc-9d1b-616969df209c11
313408timolol 0.005 MG/MG Ophthalmic GelSCDa4d03de7-06b7-4cfc-9d1b-616969df209c11
313407timolol 0.25 % Ophthalmic GelSYa4d03de7-06b7-4cfc-9d1b-616969df209c11
313407timolol 0.25 % Ophthalmic Gel Forming SolutionSYa4d03de7-06b7-4cfc-9d1b-616969df209c11
313408timolol 0.5 % (as timolol maleate 6.8 MG/ML) Ophthalmic GelSYa4d03de7-06b7-4cfc-9d1b-616969df209c11
313408timolol 0.5 % Gel Forming Ophthalmic SolutionSYa4d03de7-06b7-4cfc-9d1b-616969df209c11
861420Timoptic 0.0025 MG/MG Ophthalmic GelSYa4d03de7-06b7-4cfc-9d1b-616969df209c11
861422Timoptic 0.005 MG/MG Ophthalmic GelSYa4d03de7-06b7-4cfc-9d1b-616969df209c11
861420Timoptic-XE 0.0025 MG/MG Ophthalmic GelSYa4d03de7-06b7-4cfc-9d1b-616969df209c11
861422Timoptic-XE 0.005 MG/MG Ophthalmic GelSYa4d03de7-06b7-4cfc-9d1b-616969df209c11
861420Timoptic-XE 0.25 % Gel Forming SolutionSYa4d03de7-06b7-4cfc-9d1b-616969df209c11
861422Timoptic-XE 0.5 % Gel Forming SolutionSYa4d03de7-06b7-4cfc-9d1b-616969df209c11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
24208-814-25242080814251 BOTTLE, DISPENSING in 1 CARTON (24208-814-25) / 5 mL in 1 BOTTLE, DISPENSING2016-05-310000-00-00NoNoCurrent