Timolol Maleate

Product NDC
67877-229
11-digit product format
678770229
Labeler code
67877
Product ID
67877-229_5f58b262-3991-4c70-b7b2-b518e7cfb1fe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Timolol Maleate
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Ascend Laboratories, LLC
Application
ANDA077259
Marketing category
ANDA
Marketing start
2011-03-09
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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67877-229-11Timolol Maleate1 in 1 CARTONSOLUTION15
67877-229-11Timolol Maleate10 mL in 1 BOTTLE, DISPENSINGSOLUTION105
67877-229-15Timolol Maleate1 in 1 CARTONSOLUTION15
67877-229-15Timolol Maleate15 mL in 1 BOTTLE, DISPENSINGSOLUTION155
67877-229-55Timolol Maleate1 in 1 CARTONSOLUTION15
67877-229-55Timolol Maleate5 mL in 1 BOTTLE, DISPENSINGSOLUTION55

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TIMOLOL MALEATEACTIVE INGREDIENTP8Y54F701RTIMOLOL MALEATE SOLUTION [ASCEND LABORATORIES, LLC]4
TIMOLOL ANHYDROUSACTIVE MOIETY5JKY92S7BRTIMOLOL MALEATE SOLUTION [ASCEND LABORATORIES, LLC]4
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7TIMOLOL MALEATE SOLUTION [ASCEND LABORATORIES, LLC]4
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XTIMOLOL MALEATE SOLUTION [ASCEND LABORATORIES, LLC]4
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ITIMOLOL MALEATE SOLUTION [ASCEND LABORATORIES, LLC]4
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74TIMOLOL MALEATE SOLUTION [ASCEND LABORATORIES, LLC]4
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWTIMOLOL MALEATE SOLUTION [ASCEND LABORATORIES, LLC]4
WATERINACTIVE INGREDIENT059QF0KO0RTIMOLOL MALEATE SOLUTION [ASCEND LABORATORIES, LLC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-229TIMOLOL MALEATE SOLUTION [ASCEND LABORATORIES, LLC]5Legacy NDC, 6 package rows20190101_85724f95-6fc9-4f0c-b69d-05a23b093e2b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1992303timolol 0.5 % 12HR Ophthalmic SolutionPSN85724f95-6fc9-4f0c-b69d-05a23b093e2b5
199230312 HR timolol 5 MG/ML Ophthalmic SolutionSCD85724f95-6fc9-4f0c-b69d-05a23b093e2b5
1992303timolol 0.5 % (as timolol maleate 6.8 MG/ML) 12 HR Ophthalmic SolutionSY85724f95-6fc9-4f0c-b69d-05a23b093e2b5
1992303timolol 0.5 % 12 HR Ophthalmic SolutionSY85724f95-6fc9-4f0c-b69d-05a23b093e2b5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67877-229-11678770229111 BOTTLE, DISPENSING in 1 CARTON (67877-229-11) > 10 mL in 1 BOTTLE, DISPENSING2011-03-090000-00-00NoNoCurrent
67877-229-15678770229151 BOTTLE, DISPENSING in 1 CARTON (67877-229-15) > 15 mL in 1 BOTTLE, DISPENSING2011-03-090000-00-00NoNoCurrent
67877-229-55678770229551 BOTTLE, DISPENSING in 1 CARTON (67877-229-55) > 5 mL in 1 BOTTLE, DISPENSING2011-03-090000-00-00NoNoCurrent