FDA.reportPublic FDA data

Timolol GFS

Product NDC
61314-225
11-digit product format
613140225
Labeler code
61314
Product ID
61314-225_ba538348-67cf-4031-84e5-cb84647af104
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
timolol maleate
Dosage form
SOLUTION, GEL FORMING / DROPS
Route
OPHTHALMIC
Labeler
Sandoz Inc
Application
NDA020963
Marketing category
NDA
Marketing start
1998-12-24
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

Additional Listing Data#

Finished product
Yes
Brand name base
Timolol GFS
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TIMOLOL MALEATE5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiP8Y54F701R
Rxcui313407, 313408

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61314-225-052024-01-30C16284748780-11030e365-01bc-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use Timolol GFS safely and effectively. See full prescribing information for Timolol GFS. Timolol GFS (timolol maleate ophthalmic gel forming solution) 0.25% and 0.5%, for topical ophthalmic use. Initial U.S. Approval: 1978
61314-225-252024-01-30C16284748780-11030e365-01bc-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use Timolol GFS safely and effectively. See full prescribing information for Timolol GFS. Timolol GFS (timolol maleate ophthalmic gel forming solution) 0.25% and 0.5%, for topical ophthalmic use. Initial U.S. Approval: 1978

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61314-225-05Timolol GFS5 mL in 1 BOTTLESOLUTION, GEL FORMING / DROPS515
61314-225-25Timolol GFS2.5 mL in 1 BOTTLESOLUTION, GEL FORMING / DROPS2.515

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61314-225-05ML - Milliliter61314-225083ae698-a00c-4fa4-8706-7c3551ea490812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TIMOLOL MALEATEACTIVE INGREDIENTP8Y54F701RTIMOLOL GFS (TIMOLOL MALEATE) SOLUTION, GEL FORMING, EXTENDED RELEASE [SANDOZ INC]10
TIMOLOL ANHYDROUSACTIVE MOIETY5JKY92S7BRTIMOLOL GFS (TIMOLOL MALEATE) SOLUTION, GEL FORMING, EXTENDED RELEASE [SANDOZ INC]10
BENZODODECINIUM BROMIDEINACTIVE INGREDIENTIRY12B2TQ6TIMOLOL GFS (TIMOLOL MALEATE) SOLUTION, GEL FORMING, EXTENDED RELEASE [SANDOZ INC]10
BORIC ACIDINACTIVE INGREDIENTR57ZHV85D4TIMOLOL GFS (TIMOLOL MALEATE) SOLUTION, GEL FORMING, EXTENDED RELEASE [SANDOZ INC]10
MANNITOLINACTIVE INGREDIENT3OWL53L36ATIMOLOL GFS (TIMOLOL MALEATE) SOLUTION, GEL FORMING, EXTENDED RELEASE [SANDOZ INC]10
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HTIMOLOL GFS (TIMOLOL MALEATE) SOLUTION, GEL FORMING, EXTENDED RELEASE [SANDOZ INC]10
TROMETHAMINEINACTIVE INGREDIENT023C2WHX2VTIMOLOL GFS (TIMOLOL MALEATE) SOLUTION, GEL FORMING, EXTENDED RELEASE [SANDOZ INC]10
WATERINACTIVE INGREDIENT059QF0KO0RTIMOLOL GFS (TIMOLOL MALEATE) SOLUTION, GEL FORMING, EXTENDED RELEASE [SANDOZ INC]10
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEETIMOLOL GFS (TIMOLOL MALEATE) SOLUTION, GEL FORMING, EXTENDED RELEASE [SANDOZ INC]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61314-225TIMOLOL GFS (TIMOLOL MALEATE) SOLUTION, GEL FORMING / DROPS [SANDOZ INC]15Current NDC, Legacy NDC, 2 package rows20240608_72b0d0ec-832a-4c25-b845-2537ab506354.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313407timolol maleate 0.25 % Ophthalmic Gel Forming SolutionPSN72b0d0ec-832a-4c25-b845-2537ab50635415
313408timolol maleate 0.5 % Ophthalmic Gel Forming SolutionPSN72b0d0ec-832a-4c25-b845-2537ab50635415
313407timolol 0.0025 MG/MG Ophthalmic GelSCD72b0d0ec-832a-4c25-b845-2537ab50635415
313408timolol 0.005 MG/MG Ophthalmic GelSCD72b0d0ec-832a-4c25-b845-2537ab50635415
313407timolol 0.25 % Ophthalmic GelSY72b0d0ec-832a-4c25-b845-2537ab50635415
313407timolol 0.25 % Ophthalmic Gel Forming SolutionSY72b0d0ec-832a-4c25-b845-2537ab50635415
313408timolol 0.5 % (as timolol maleate 6.8 MG/ML) Ophthalmic GelSY72b0d0ec-832a-4c25-b845-2537ab50635415
313408timolol 0.5 % Gel Forming Ophthalmic SolutionSY72b0d0ec-832a-4c25-b845-2537ab50635415

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61314-225-05613140225055 mL in 1 BOTTLE (61314-225-05) 5 ml1998-12-240000-00-00NoNoCurrent
61314-225-25613140225252.5 mL in 1 BOTTLE (61314-225-25) 2.5 ml1998-12-240000-00-00NoNoCurrent