Timolol Maleate Ophthalmic Gel Forming Solution

Product NDC
72266-199
11-digit product format
722660199
Labeler code
72266
Product ID
72266-199_3a229bef-de33-9ec4-e063-6394a90ad1b7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Timolol Maleate Ophthalmic Gel Forming Solution
Dosage form
SOLUTION, GEL FORMING / DROPS
Route
OPHTHALMIC
Labeler
FOSUN PHARMA USA INC
Application
ANDA214645
Marketing category
ANDA
Marketing start
2022-06-24
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 42.

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
A214645-001TIMOLOL MALEATETIMOLOL MALEATEEQ 0.25% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICAB2022-06-24
A214645-002TIMOLOL MALEATETIMOLOL MALEATEEQ 0.5% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICAB2023-02-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A214645-001AB
A214645-002AB

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 · 53 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A214645-001TIMOLOL MALEATEEQ 0.25% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICAB2022-06-24caaa826d4ba7…
2026-08-18 06:07:402026-07A214645-002TIMOLOL MALEATEEQ 0.5% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICAB2023-02-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A214645-001TIMOLOL MALEATEEQ 0.25% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICAB2022-06-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214645-002TIMOLOL MALEATEEQ 0.5% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICAB2023-02-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214645-001TIMOLOL MALEATEEQ 0.25% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICAB2022-06-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214645-002TIMOLOL MALEATEEQ 0.5% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICAB2023-02-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A214645-001TIMOLOL MALEATEEQ 0.25% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICAB2022-06-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214645-002TIMOLOL MALEATEEQ 0.5% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICAB2023-02-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214645-001TIMOLOL MALEATEEQ 0.25% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICAB2022-06-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214645-002TIMOLOL MALEATEEQ 0.5% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICAB2023-02-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214645-001TIMOLOL MALEATEEQ 0.25% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICAB2022-06-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214645-002TIMOLOL MALEATEEQ 0.5% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICAB2023-02-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214645-001TIMOLOL MALEATEEQ 0.25% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICAB2022-06-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214645-002TIMOLOL MALEATEEQ 0.5% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICAB2023-02-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214645-001TIMOLOL MALEATEEQ 0.25% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICAB2022-06-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214645-002TIMOLOL MALEATEEQ 0.5% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICAB2023-02-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214645-001TIMOLOL MALEATEEQ 0.25% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICAB2022-06-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214645-002TIMOLOL MALEATEEQ 0.5% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICAB2023-02-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214645-001TIMOLOL MALEATEEQ 0.25% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICAB2022-06-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214645-002TIMOLOL MALEATEEQ 0.5% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICAB2023-02-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214645-001TIMOLOL MALEATEEQ 0.25% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICAB2022-06-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A214645-002TIMOLOL MALEATEEQ 0.5% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICAB2023-02-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214645-001TIMOLOL MALEATEEQ 0.25% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICAB2022-06-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214645-002TIMOLOL MALEATEEQ 0.5% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICAB2023-02-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214645-001TIMOLOL MALEATEEQ 0.25% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICAB2022-06-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214645-002TIMOLOL MALEATEEQ 0.5% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICAB2023-02-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214645-001TIMOLOL MALEATEEQ 0.25% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICAB2022-06-241e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214645-002TIMOLOL MALEATEEQ 0.5% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICAB2023-02-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214645-001TIMOLOL MALEATEEQ 0.25% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICAB2022-06-248072bd15b7f6…
2024-05-31 18:47 UTC2024-05A214645-002TIMOLOL MALEATEEQ 0.5% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICAB2023-02-148072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A214645-001TIMOLOL MALEATEEQ 0.25% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICAB2022-06-246a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A214645-002TIMOLOL MALEATEEQ 0.5% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICAB2023-02-146a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A214645-001TIMOLOL MALEATEEQ 0.25% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICAB2022-06-241c564ffb4f44…
2024-02-18 07:12 UTC2024-02A214645-002TIMOLOL MALEATEEQ 0.5% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICAB2023-02-141c564ffb4f44…
2023-12-20 04:57 UTC2023-12A214645-001TIMOLOL MALEATEEQ 0.25% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICAB2022-06-24ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A214645-002TIMOLOL MALEATEEQ 0.5% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICAB2023-02-14ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A214645-001TIMOLOL MALEATEEQ 0.25% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICAB2022-06-24a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A214645-002TIMOLOL MALEATEEQ 0.5% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICAB2023-02-14a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A214645-001TIMOLOL MALEATEEQ 0.25% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICAB2022-06-249b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A214645-002TIMOLOL MALEATEEQ 0.5% BASESOLUTION, GEL FORMING/DROPS / OPHTHALMICAB2023-02-149b2671bbb829…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 53 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A214645-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A214645-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A214645-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214645-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214645-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214645-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A214645-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214645-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214645-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214645-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214645-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214645-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214645-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214645-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214645-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214645-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214645-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214645-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214645-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214645-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214645-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A214645-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214645-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214645-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214645-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214645-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214645-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214645-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214645-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A214645-002AB18072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A214645-001AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A214645-002AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A214645-001AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A214645-002AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A214645-001AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A214645-002AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A214645-001AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A214645-002AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A214645-001AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A214645-002AB19b2671bbb829…

Additional Listing Data#

Finished product
Yes
Brand name base
Timolol Maleate Ophthalmic Gel Forming Solution
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 · 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
e93036c6-3120-e989-e053-2a95a90acf7fAvailable 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
72266-199-01Timolol Maleate Ophthalmic Gel Forming Solution5 mL in 1 BOTTLESOLUTION, GEL FORMING / DROPS56
72266-199-01Timolol Maleate Ophthalmic Gel Forming Solution1 in 1 CARTONSOLUTION, GEL FORMING / DROPS16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72266-199-01ML - Milliliter72266-199f7912d22-9b12-40b6-a0e0-b0e3e9eea18612022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72266-199TIMOLOL MALEATE OPHTHALMIC GEL FORMING SOLUTION SOLUTION, GEL FORMING / DROPS [FOSUN PHARMA USA INC]5Current NDC, Legacy NDC, 2 package rows20250323_e93036c6-3120-e989-e053-2a95a90acf7f.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Timolol MaleateTIMOLOL MALEATESagent Pharmaceuticals272bb565-f099-4896-b2f6-48ab9180e9412026-01-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214645
application number: ANDA214645
Timolol Maleate Ophthalmic Gel Forming SolutionTIMOLOL MALEATE OPHTHALMIC GEL FORMING SOLUTIONFOSUN PHARMA USA INCe93036c6-3120-e989-e053-2a95a90acf7f2023-02-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214645
application number: ANDA214645
ndc (product): 72266-199
timolol maleate ophthalmic gel forming solutionTIMOLOL MALEATE OPHTHALMIC GEL FORMING SOLUTIONGland Pharma Limited79730e4f-d533-42c7-b7b6-cdbc47242baa2023-02-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214645
application number: ANDA214645

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313407timolol maleate 0.25 % Ophthalmic Gel Forming SolutionPSNe93036c6-3120-e989-e053-2a95a90acf7f6
313408timolol maleate 0.5 % Ophthalmic Gel Forming SolutionPSNe93036c6-3120-e989-e053-2a95a90acf7f6
313407timolol 0.0025 MG/MG Ophthalmic GelSCDe93036c6-3120-e989-e053-2a95a90acf7f6
313408timolol 0.005 MG/MG Ophthalmic GelSCDe93036c6-3120-e989-e053-2a95a90acf7f6
313407timolol 0.25 % Ophthalmic GelSYe93036c6-3120-e989-e053-2a95a90acf7f6
313407timolol 0.25 % Ophthalmic Gel Forming SolutionSYe93036c6-3120-e989-e053-2a95a90acf7f6
313408timolol 0.5 % (as timolol maleate 6.8 MG/ML) Ophthalmic GelSYe93036c6-3120-e989-e053-2a95a90acf7f6
313408timolol 0.5 % Gel Forming Ophthalmic SolutionSYe93036c6-3120-e989-e053-2a95a90acf7f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72266-199-01722660199011 BOTTLE in 1 CARTON (72266-199-01) / 5 mL in 1 BOTTLE1 bottle2022-09-260000-00-00NoNoCurrent