Timolol Maleate Ophthalmic Gel Forming Solution 0.5%

Product NDC
43598-748
11-digit product format
435980748
Labeler code
43598
Product ID
43598-748_bc484449-5dbd-e029-8a18-10c5af1205a0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Timolol Maleate Ophthalmic Gel Forming Solution 0.5%
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Dr. Reddy's Laboratories, Inc.
Application
ANDA215733
Marketing category
ANDA
Marketing start
2022-11-15
Substance
TIMOLOL MALEATE
Active strength
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
A215733-001TIMOLOL MALEATETIMOLOL MALEATEEQ 0.25% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICAB2022-09-22
A215733-002TIMOLOL MALEATETIMOLOL MALEATEEQ 0.5% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICAB2022-09-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A215733-001AB
A215733-002AB

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 2 · 52 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A215733-001TIMOLOL MALEATEEQ 0.25% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICAB2022-09-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215733-002TIMOLOL MALEATEEQ 0.5% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICAB2022-09-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215733-001TIMOLOL MALEATEEQ 0.25% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICAB2022-09-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215733-002TIMOLOL MALEATEEQ 0.5% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICAB2022-09-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A215733-001TIMOLOL MALEATEEQ 0.25% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICAB2022-09-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215733-002TIMOLOL MALEATEEQ 0.5% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICAB2022-09-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215733-001TIMOLOL MALEATEEQ 0.25% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICAB2022-09-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215733-002TIMOLOL MALEATEEQ 0.5% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICAB2022-09-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215733-001TIMOLOL MALEATEEQ 0.25% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICAB2022-09-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215733-002TIMOLOL MALEATEEQ 0.5% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICAB2022-09-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215733-001TIMOLOL MALEATEEQ 0.25% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICAB2022-09-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215733-002TIMOLOL MALEATEEQ 0.5% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICAB2022-09-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215733-001TIMOLOL MALEATEEQ 0.25% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICAB2022-09-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215733-002TIMOLOL MALEATEEQ 0.5% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICAB2022-09-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215733-001TIMOLOL MALEATEEQ 0.25% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICAB2022-09-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215733-002TIMOLOL MALEATEEQ 0.5% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICAB2022-09-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215733-001TIMOLOL MALEATEEQ 0.25% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICAB2022-09-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215733-002TIMOLOL MALEATEEQ 0.5% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICAB2022-09-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A215733-001TIMOLOL MALEATEEQ 0.25% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICAB2022-09-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A215733-002TIMOLOL MALEATEEQ 0.5% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICAB2022-09-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215733-001TIMOLOL MALEATEEQ 0.25% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICAB2022-09-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215733-002TIMOLOL MALEATEEQ 0.5% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICAB2022-09-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215733-001TIMOLOL MALEATEEQ 0.25% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICAB2022-09-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215733-002TIMOLOL MALEATEEQ 0.5% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICAB2022-09-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215733-001TIMOLOL MALEATEEQ 0.25% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICAB2022-09-221e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215733-002TIMOLOL MALEATEEQ 0.5% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICAB2022-09-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A215733-001TIMOLOL MALEATEEQ 0.25% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICAB2022-09-228072bd15b7f6…
2024-05-31 18:47 UTC2024-05A215733-002TIMOLOL MALEATEEQ 0.5% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICAB2022-09-228072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A215733-001TIMOLOL MALEATEEQ 0.25% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICAB2022-09-226a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A215733-002TIMOLOL MALEATEEQ 0.5% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICAB2022-09-226a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A215733-001TIMOLOL MALEATEEQ 0.25% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICAB2022-09-221c564ffb4f44…
2024-02-18 07:12 UTC2024-02A215733-002TIMOLOL MALEATEEQ 0.5% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICAB2022-09-221c564ffb4f44…
2023-12-20 04:57 UTC2023-12A215733-001TIMOLOL MALEATEEQ 0.25% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICAB2022-09-22ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A215733-002TIMOLOL MALEATEEQ 0.5% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICAB2022-09-22ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A215733-001TIMOLOL MALEATEEQ 0.25% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICAB2022-09-22a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A215733-002TIMOLOL MALEATEEQ 0.5% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICAB2022-09-22a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A215733-001TIMOLOL MALEATEEQ 0.25% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICAB2022-09-229b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A215733-002TIMOLOL MALEATEEQ 0.5% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICAB2022-09-229b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A215733-001TIMOLOL MALEATEEQ 0.25% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICAB2022-09-22a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A215733-002TIMOLOL MALEATEEQ 0.5% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICAB2022-09-22a67488948f0b…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 52 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A215733-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215733-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215733-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215733-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A215733-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215733-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215733-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215733-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215733-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215733-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215733-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215733-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215733-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215733-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215733-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215733-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215733-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215733-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A215733-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A215733-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215733-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215733-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215733-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215733-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215733-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215733-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A215733-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A215733-002AB18072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A215733-001AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A215733-002AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A215733-001AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A215733-002AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A215733-001AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A215733-002AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A215733-001AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A215733-002AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A215733-001AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A215733-002AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A215733-001AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A215733-002AB1a67488948f0b…

Additional Listing Data#

Finished product
Yes
Brand name base
Timolol Maleate Ophthalmic Gel Forming Solution 0.5%
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TIMOLOL MALEATE5 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 · 2 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d987fdfa-3643-aa1d-cacd-c4f95f192ce7Available 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
43598-748-11Timolol Maleate Ophthalmic Gel Forming Solution 0.5%1 in 1 CARTONSOLUTION/ DROPS16
43598-748-11Timolol Maleate Ophthalmic Gel Forming Solution 0.5%5 mL in 1 BOTTLESOLUTION/ DROPS56

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-748-11ML - Milliliter43598-748b17dabe0-c9a5-4fe5-827a-c273c60a6a2c12023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-748TIMOLOL MALEATE OPHTHALMIC GEL FORMING SOLUTION 0.5% SOLUTION/ DROPS TIMOLOL MALEATE OPHTHALMIC GEL FORMING SOLUTION 0.25% SOLUTION/ DROPS [DR. REDDY'S LABORATORIES, INC.]6Current NDC, Legacy NDC, 2 package rows20240627_d987fdfa-3643-aa1d-cacd-c4f95f192ce7.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 Maleate Ophthalmic Gel Forming Solution 0.25%TIMOLOL MALEATE OPHTHALMIC GEL FORMING SOLUTION 0.25%NorthStar RxLLC9515f95c-e29b-3c7f-0bdd-cda783988a722023-07-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215733
application number: ANDA215733
Timolol Maleate Ophthalmic Gel Forming Solution 0.25%TIMOLOL MALEATE OPHTHALMIC GEL FORMING SOLUTION 0.25%Dr. Reddy's Laboratories, Inc.d987fdfa-3643-aa1d-cacd-c4f95f192ce72021-08-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215733
application number: ANDA215733
ndc (product): 43598-748

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313407timolol maleate 0.25 % Ophthalmic Gel Forming SolutionPSNd987fdfa-3643-aa1d-cacd-c4f95f192ce76
313408timolol maleate 0.5 % Ophthalmic Gel Forming SolutionPSNd987fdfa-3643-aa1d-cacd-c4f95f192ce76
313407timolol 0.0025 MG/MG Ophthalmic GelSCDd987fdfa-3643-aa1d-cacd-c4f95f192ce76
313408timolol 0.005 MG/MG Ophthalmic GelSCDd987fdfa-3643-aa1d-cacd-c4f95f192ce76
313407timolol 0.25 % Ophthalmic GelSYd987fdfa-3643-aa1d-cacd-c4f95f192ce76
313407timolol 0.25 % Ophthalmic Gel Forming SolutionSYd987fdfa-3643-aa1d-cacd-c4f95f192ce76
313408timolol 0.5 % (as timolol maleate 6.8 MG/ML) Ophthalmic GelSYd987fdfa-3643-aa1d-cacd-c4f95f192ce76
313408timolol 0.5 % Gel Forming Ophthalmic SolutionSYd987fdfa-3643-aa1d-cacd-c4f95f192ce76

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43598-748-11435980748111 BOTTLE in 1 CARTON (43598-748-11) / 5 mL in 1 BOTTLE1 bottle2022-11-150000-00-00NoNoCurrent