FDA.reportPublic FDA data

TIMOLOL MALEATE

Product NDC
55545-1001
11-digit product format
555451001
Labeler code
55545
Product ID
55545-1001_5de7796b-8c4b-4e1a-96c2-3ee63a576a68
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
timolol maleate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
FDC Limited
Application
ANDA077259
Marketing category
ANDA
Marketing start
2014-12-15
Marketing end
0000-00-00
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
2020-12-31
Current FDA listing
Historical FDA.report record

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
55545-1001-1TIMOLOL MALEATE1 in 1 CARTONSOLUTION/ DROPS13
55545-1001-1TIMOLOL MALEATE5 mL in 1 BOTTLESOLUTION/ DROPS53
55545-1001-2TIMOLOL MALEATE10 mL in 1 BOTTLESOLUTION/ DROPS103
55545-1001-2TIMOLOL MALEATE1 in 1 CARTONSOLUTION/ DROPS13
55545-1001-3TIMOLOL MALEATE15 mL in 1 BOTTLESOLUTION/ DROPS153
55545-1001-3TIMOLOL MALEATE1 in 1 CARTONSOLUTION/ DROPS13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TIMOLOL MALEATEACTIVE INGREDIENTP8Y54F701RTIMOLOL MALEATE SOLUTION/ DROPS [FDC LIMITED]2
TIMOLOL ANHYDROUSACTIVE MOIETY5JKY92S7BRTIMOLOL MALEATE SOLUTION/ DROPS [FDC LIMITED]2
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7TIMOLOL MALEATE SOLUTION/ DROPS [FDC LIMITED]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XTIMOLOL MALEATE SOLUTION/ DROPS [FDC LIMITED]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ITIMOLOL MALEATE SOLUTION/ DROPS [FDC LIMITED]2
SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATEINACTIVE INGREDIENTE1W4N241FOTIMOLOL MALEATE SOLUTION/ DROPS [FDC LIMITED]2
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATEINACTIVE INGREDIENT5QWK665956TIMOLOL MALEATE SOLUTION/ DROPS [FDC LIMITED]2
WATERINACTIVE INGREDIENT059QF0KO0RTIMOLOL MALEATE SOLUTION/ DROPS [FDC LIMITED]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55545-1001TIMOLOL MALEATE SOLUTION/ DROPS [FDC LIMITED]3Legacy NDC, 6 package rows20171122_42887224-997c-4f08-8e2c-918de7195a6e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1992303timolol 0.5 % 12HR Ophthalmic SolutionPSN42887224-997c-4f08-8e2c-918de7195a6e3
199230312 HR timolol 5 MG/ML Ophthalmic SolutionSCD42887224-997c-4f08-8e2c-918de7195a6e3
1992303timolol 0.5 % (as timolol maleate 6.8 MG/ML) 12 HR Ophthalmic SolutionSY42887224-997c-4f08-8e2c-918de7195a6e3
1992303timolol 0.5 % 12 HR Ophthalmic SolutionSY42887224-997c-4f08-8e2c-918de7195a6e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
55545-1001-1555451001011 in 1 CARTONHistorical
55545-1001-25554510010210 mL in 1 BOTTLE10 mlHistorical
55545-1001-35554510010315 mL in 1 BOTTLE15 mlHistorical