Timoptic in Ocudose

Product NDC
24208-499
11-digit product format
242080499
Labeler code
24208
Product ID
24208-499_fb4b627c-422c-471a-bcec-fff7187d79d7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Timolol Maleate
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Bausch & Lomb Incorporated
Application
NDA019463
Marketing category
NDA
Marketing start
2022-02-17
Substance
TIMOLOL MALEATE
Active strength
6.8 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
N019463-001TIMOPTIC IN OCUDOSETIMOLOL MALEATEEQ 0.25% BASESOLUTION/DROPS / OPHTHALMICAT3RLD, RS1986-11-05
N019463-002TIMOPTIC IN OCUDOSETIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT3RLD, RS1986-11-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N019463-001AT3
N019463-002AT3

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 UTC2026-02N019463-001TIMOPTIC IN OCUDOSEEQ 0.25% BASESOLUTION/DROPS / OPHTHALMICAT3RLD, RS1986-11-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019463-002TIMOPTIC IN OCUDOSEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT3RLD, RS1986-11-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019463-001TIMOPTIC IN OCUDOSEEQ 0.25% BASESOLUTION/DROPS / OPHTHALMICAT3RLD, RS1986-11-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019463-002TIMOPTIC IN OCUDOSEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT3RLD, RS1986-11-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08N019463-001TIMOPTIC IN OCUDOSEEQ 0.25% BASESOLUTION/DROPS / OPHTHALMICAT3RLD, RS1986-11-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019463-002TIMOPTIC IN OCUDOSEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT3RLD, RS1986-11-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019463-001TIMOPTIC IN OCUDOSEEQ 0.25% BASESOLUTION/DROPS / OPHTHALMICAT3RLD, RS1986-11-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019463-002TIMOPTIC IN OCUDOSEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT3RLD, RS1986-11-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019463-001TIMOPTIC IN OCUDOSEEQ 0.25% BASESOLUTION/DROPS / OPHTHALMICAT3RLD, RS1986-11-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019463-002TIMOPTIC IN OCUDOSEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT3RLD, RS1986-11-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019463-001TIMOPTIC IN OCUDOSEEQ 0.25% BASESOLUTION/DROPS / OPHTHALMICAT3RLD, RS1986-11-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019463-002TIMOPTIC IN OCUDOSEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT3RLD, RS1986-11-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019463-001TIMOPTIC IN OCUDOSEEQ 0.25% BASESOLUTION/DROPS / OPHTHALMICAT3RLD, RS1986-11-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019463-002TIMOPTIC IN OCUDOSEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT3RLD, RS1986-11-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019463-001TIMOPTIC IN OCUDOSEEQ 0.25% BASESOLUTION/DROPS / OPHTHALMICAT3RLD, RS1986-11-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019463-002TIMOPTIC IN OCUDOSEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT3RLD, RS1986-11-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019463-001TIMOPTIC IN OCUDOSEEQ 0.25% BASESOLUTION/DROPS / OPHTHALMICAT3RLD, RS1986-11-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019463-002TIMOPTIC IN OCUDOSEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT3RLD, RS1986-11-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019463-001TIMOPTIC IN OCUDOSEEQ 0.25% BASESOLUTION/DROPS / OPHTHALMICAT3RLD, RS1986-11-05d06236e962d9…
2024-10-29 15:01 UTC2024-10N019463-002TIMOPTIC IN OCUDOSEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT3RLD, RS1986-11-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019463-001TIMOPTIC IN OCUDOSEEQ 0.25% BASESOLUTION/DROPS / OPHTHALMICAT3RLD, RS1986-11-0579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019463-002TIMOPTIC IN OCUDOSEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT3RLD, RS1986-11-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019463-001TIMOPTIC IN OCUDOSEEQ 0.25% BASESOLUTION/DROPS / OPHTHALMICAT3RLD, RS1986-11-05301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019463-002TIMOPTIC IN OCUDOSEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT3RLD, RS1986-11-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019463-001TIMOPTIC IN OCUDOSEEQ 0.25% BASESOLUTION/DROPS / OPHTHALMICAT3RLD, RS1986-11-051e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019463-002TIMOPTIC IN OCUDOSEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT3RLD, RS1986-11-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05N019463-001TIMOPTIC IN OCUDOSEEQ 0.25% BASESOLUTION/DROPS / OPHTHALMICAT3RLD, RS1986-11-058072bd15b7f6…
2024-05-31 18:47 UTC2024-05N019463-002TIMOPTIC IN OCUDOSEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT3RLD, RS1986-11-058072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019463-001TIMOPTIC IN OCUDOSEEQ 0.25% BASESOLUTION/DROPS / OPHTHALMICAT3RLD, RS1986-11-055c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019463-002TIMOPTIC IN OCUDOSEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT3RLD, RS1986-11-055c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N019463-001TIMOPTIC IN OCUDOSEEQ 0.25% BASESOLUTION/DROPS / OPHTHALMICAT3RLD, RS1986-11-055d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N019463-002TIMOPTIC IN OCUDOSEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT3RLD, RS1986-11-055d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N019463-001TIMOPTIC IN OCUDOSEEQ 0.25% BASESOLUTION/DROPS / OPHTHALMICAT3RLD, RS1986-11-054b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N019463-002TIMOPTIC IN OCUDOSEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT3RLD, RS1986-11-054b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N019463-001TIMOPTIC IN OCUDOSEEQ 0.25% BASESOLUTION/DROPS / OPHTHALMICRLD, RS1986-11-0574a2ff9319b5…
2019-12-13 00:20 UTC2019-12N019463-002TIMOPTIC IN OCUDOSEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICRLD, RS1986-11-0574a2ff9319b5…
2022-03-09 01:35 UTC2022-03N019463-001TIMOPTIC IN OCUDOSEEQ 0.25% BASESOLUTION/DROPS / OPHTHALMICAT3RLD, RS1986-11-05bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N019463-002TIMOPTIC IN OCUDOSEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT3RLD, RS1986-11-05bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N019463-001TIMOPTIC IN OCUDOSEEQ 0.25% BASESOLUTION/DROPS / OPHTHALMICRLD, RS1986-11-05782e0a99824c…
2021-12-28 21:50 UTC2021-12N019463-002TIMOPTIC IN OCUDOSEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT3RLD, RS1986-11-05782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 69 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N019463-001AT31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019463-002AT31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019463-001AT3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019463-002AT3131067a03dcf5…
2025-08-23 18:47 UTC2025-08N019463-001AT316a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019463-002AT316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019463-001AT31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019463-002AT31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019463-001AT31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019463-002AT31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019463-001AT3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019463-002AT3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019463-001AT312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019463-002AT312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019463-001AT315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019463-002AT315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019463-001AT31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019463-002AT31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019463-001AT31d06236e962d9…
2024-10-29 15:01 UTC2024-10N019463-002AT31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019463-001AT3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019463-002AT3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019463-001AT31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019463-002AT31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019463-001AT311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019463-002AT311e350fbaab3a…
2024-05-31 18:47 UTC2024-05N019463-001AT318072bd15b7f6…
2024-05-31 18:47 UTC2024-05N019463-002AT318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019463-001AT315c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019463-002AT315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N019463-001AT315d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N019463-002AT315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N019463-001AT314b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N019463-002AT314b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N019463-001AT31bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N019463-002AT31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N019463-002AT31782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N019463-002AT3187673890dc5c…
2021-03-12 10:30 UTC2021-03N019463-002AT315aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N019463-002AT318869cabd3fbd…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TIMOLOL MALEATE6.8 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
1922876Internal RxNorm lookup
1922877Internal RxNorm lookup
1922894Internal RxNorm lookup
1922895Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d130f0ec-c3b5-4bc3-8f4a-68fd6c3ec0cfAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6c0c444-a6ba-2fb5-a7bc-7f0443fa5791Product name420251208
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
24208-499-00Timoptic in Ocudose1 in 1 CARTONSOLUTION12
24208-499-00Timoptic in Ocudose10 in 1 POUCHSOLUTION102
24208-499-68Timoptic in Ocudose10 in 1 POUCHSOLUTION102
24208-499-68Timoptic in Ocudose6 in 1 CARTONSOLUTION62

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24208-499-68EA - Each24208-4991f382261-e3af-4448-831d-aa896d8c5ad612023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24208-499TIMOPTIC IN OCUDOSE (TIMOLOL MALEATE) SOLUTION [BAUSCH & LOMB INCORPORATED]2Current NDC, Legacy NDC, 4 package rows20220222_d130f0ec-c3b5-4bc3-8f4a-68fd6c3ec0cf.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.036dc753-1698-4c69-9bcf-752c7061203c2025-03-05Warnings, Adverse reactionsExact identifier
application applno (NDA): 019463
application number: NDA019463
Timoptic in OcudoseTIMOLOL MALEATEBausch & Lomb Incorporatedd130f0ec-c3b5-4bc3-8f4a-68fd6c3ec0cf2022-01-31Warnings, Adverse reactionsExact identifier
application applno (NDA): 019463
application number: NDA019463
ndc (product): 24208-499

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1922876timolol PF 0.25 % Ophthalmic SolutionPSNd130f0ec-c3b5-4bc3-8f4a-68fd6c3ec0cf2
1922894timolol PF 0.5 % Ophthalmic SolutionPSNd130f0ec-c3b5-4bc3-8f4a-68fd6c3ec0cf2
1922877Timoptic PF 0.25 % Ophthalmic SolutionPSNd130f0ec-c3b5-4bc3-8f4a-68fd6c3ec0cf2
1922895Timoptic PF 0.5 % Ophthalmic SolutionPSNd130f0ec-c3b5-4bc3-8f4a-68fd6c3ec0cf2
1922877Preservative-Free timolol 2.5 MG/ML Ophthalmic Solution [Timoptic]SBDd130f0ec-c3b5-4bc3-8f4a-68fd6c3ec0cf2
1922895Preservative-Free timolol 5 MG/ML Ophthalmic Solution [Timoptic]SBDd130f0ec-c3b5-4bc3-8f4a-68fd6c3ec0cf2
1922876Preservative-Free timolol 2.5 MG/ML Ophthalmic SolutionSCDd130f0ec-c3b5-4bc3-8f4a-68fd6c3ec0cf2
1922894Preservative-Free timolol 5 MG/ML Ophthalmic SolutionSCDd130f0ec-c3b5-4bc3-8f4a-68fd6c3ec0cf2
1922895Preservative-Free Timoptic 5 MG/ML Ophthalmic SolutionSYd130f0ec-c3b5-4bc3-8f4a-68fd6c3ec0cf2
1922876timolol PF 0.25 % Ophthalmic SolutionSYd130f0ec-c3b5-4bc3-8f4a-68fd6c3ec0cf2
1922894timolol PF 0.5 % Ophthalmic SolutionSYd130f0ec-c3b5-4bc3-8f4a-68fd6c3ec0cf2
1922876timolol PF 2.5 MG/ML (as timolol maleate 3.4 MG/ML) Ophthalmic SolutionSYd130f0ec-c3b5-4bc3-8f4a-68fd6c3ec0cf2
1922894timolol PF 5 MG/ML (as timolol maleate 6.8 MG/ML) Ophthalmic SolutionSYd130f0ec-c3b5-4bc3-8f4a-68fd6c3ec0cf2
1922877Timoptic PF 0.25 % Ophthalmic SolutionSYd130f0ec-c3b5-4bc3-8f4a-68fd6c3ec0cf2
1922895Timoptic PF 0.5 % Ophthalmic SolutionSYd130f0ec-c3b5-4bc3-8f4a-68fd6c3ec0cf2
1922877Timoptic PF 2.5 MG/ML Ophthalmic SolutionSYd130f0ec-c3b5-4bc3-8f4a-68fd6c3ec0cf2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
24208-499-00242080499001 POUCH in 1 CARTON (24208-499-00) / 10 CONTAINER in 1 POUCH / .3 mL in 1 CONTAINER1 pouch2022-02-170000-00-00YesNoCurrent
24208-499-68242080499686 POUCH in 1 CARTON (24208-499-68) / 10 CONTAINER in 1 POUCH / .3 mL in 1 CONTAINER6 pouch2022-02-170000-00-00NoNoCurrent