TIMOLOL MALEATE

Product NDC
55545-1000
11-digit product format
555451000
Labeler code
55545
Product ID
55545-1000_a4cd6743-0942-4ae6-b2d4-8a23786b86d4
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
3 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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
273981e4-09e7-45cc-967c-554f628ededfProduct name320230627
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
97dad5a2-c524-a7b5-dede-82edefe9ce62Product name720220929
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
d11e749b-f93e-0ce3-ceda-28fe03d8081dProduct name220190731
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55545-1000-1TIMOLOL MALEATE1 in 1 CARTONSOLUTION/ DROPS13
55545-1000-1TIMOLOL MALEATE5 mL in 1 BOTTLESOLUTION/ DROPS53
55545-1000-2TIMOLOL MALEATE10 mL in 1 BOTTLESOLUTION/ DROPS103
55545-1000-2TIMOLOL MALEATE1 in 1 CARTONSOLUTION/ DROPS13
55545-1000-3TIMOLOL MALEATE1 in 1 CARTONSOLUTION/ DROPS13
55545-1000-3TIMOLOL MALEATE15 mL in 1 BOTTLESOLUTION/ DROPS153

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, DIBASICINACTIVE INGREDIENTGR686LBA74TIMOLOL MALEATE SOLUTION/ DROPS [FDC LIMITED]2
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWTIMOLOL 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
55545-1000TIMOLOL MALEATE SOLUTION/ DROPS [FDC LIMITED]3Legacy NDC, 6 package rows20171122_2101d051-411e-466c-bba6-166a4615b17b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1923428timolol maleate 0.25 % Ophthalmic SolutionPSN2101d051-411e-466c-bba6-166a4615b17b3
1923428timolol 2.5 MG/ML Ophthalmic SolutionSCD2101d051-411e-466c-bba6-166a4615b17b3
1923428timolol 0.25 % Ophthalmic SolutionSY2101d051-411e-466c-bba6-166a4615b17b3
1923428timolol 2.5 MG/ML (as timolol maleate 3.4 MG/ML) Ophthalmic SolutionSY2101d051-411e-466c-bba6-166a4615b17b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
55545-1000-1555451000011 in 1 CARTONHistorical
55545-1000-25554510000210 mL in 1 BOTTLE10 mlHistorical
55545-1000-3555451000031 in 1 CARTONHistorical