TIMOLOL MALEATE

Product NDC
76519-1163
11-digit product format
765191163
Labeler code
76519
Product ID
76519-1163_92c79a2d-f3b7-236b-e053-2a95a90a06a7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TIMOLOL MALEATE
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
H.J. Harkins Company, Inc.
Application
ANDA077259
Marketing category
ANDA
Marketing start
2018-11-02
Marketing end
0000-00-00
Substance
TIMOLOL MALEATE
Active strength
0 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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76519-1163-02022-01-28C16284748780-1d6a99b39-5080-a426-e053-dadaa90af4c21163 TIMOLOL MALEATE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76519-1163-0TIMOLOL MALEATE5 mL in 1 BOTTLESOLUTION/ DROPS51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76519-1163TIMOLOL MALEATE SOLUTION/ DROPS [H.J. HARKINS COMPANY, INC.]1Legacy NDC, 1 package rows20190919_92c79a2d-f3b6-236b-e053-2a95a90a06a7.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76519-1163-0765191163005 mL in 1 BOTTLE (76519-1163-0) 5 ml2018-11-020000-00-00NoNoCurrent