FDA.reportPublic FDA data

TIMOLOL MALEATE

Product NDC
64980-514
11-digit product format
649800514
Labeler code
64980
Product ID
64980-514_7ef88352-6fe4-48a4-b72b-15419d3ed051
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
timolol maleate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA077259
Marketing category
ANDA
Marketing start
2014-12-15
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 MALEATE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TIMOLOL MALEATE5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiP8Y54F701R
Rxcui1923428, 1992303

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
64980-514-01TIMOLOL MALEATE1 in 1 CARTONSOLUTION/ DROPS110
64980-514-01TIMOLOL MALEATE10 mL in 1 BOTTLESOLUTION/ DROPS1010
64980-514-05TIMOLOL MALEATE5 mL in 1 BOTTLESOLUTION/ DROPS510
64980-514-05TIMOLOL MALEATE1 in 1 CARTONSOLUTION/ DROPS110
64980-514-15TIMOLOL MALEATE15 mL in 1 BOTTLESOLUTION/ DROPS1510
64980-514-15TIMOLOL MALEATE1 in 1 CARTONSOLUTION/ DROPS110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64980-514-01ML - Milliliter64980-5142cb30507-a5b2-4dab-b41d-993b7644933012015-05-05
64980-514-05ML - Milliliter64980-51471353c2a-71df-4c38-a616-3df7c96ab1f012015-05-05
64980-514-15ML - Milliliter64980-5140a09233b-8db3-475a-aa86-c224362e5a6e12015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TIMOLOL MALEATEACTIVE INGREDIENTP8Y54F701RTIMOLOL MALEATE SOLUTION/ DROPS [RISING PHARMACEUTICALS, INC.]1
TIMOLOL ANHYDROUSACTIVE MOIETY5JKY92S7BRTIMOLOL MALEATE SOLUTION/ DROPS [RISING PHARMACEUTICALS, INC.]1
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7TIMOLOL MALEATE SOLUTION/ DROPS [RISING PHARMACEUTICALS, INC.]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XTIMOLOL MALEATE SOLUTION/ DROPS [RISING PHARMACEUTICALS, INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ITIMOLOL MALEATE SOLUTION/ DROPS [RISING PHARMACEUTICALS, INC.]1
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74TIMOLOL MALEATE SOLUTION/ DROPS [RISING PHARMACEUTICALS, INC.]1
SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATEINACTIVE INGREDIENTE1W4N241FOTIMOLOL MALEATE SOLUTION/ DROPS [RISING PHARMACEUTICALS, INC.]1
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWTIMOLOL MALEATE SOLUTION/ DROPS [RISING PHARMACEUTICALS, INC.]1
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATEINACTIVE INGREDIENT5QWK665956TIMOLOL MALEATE SOLUTION/ DROPS [RISING PHARMACEUTICALS, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RTIMOLOL MALEATE SOLUTION/ DROPS [RISING PHARMACEUTICALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64980-514TIMOLOL MALEATE SOLUTION/ DROPS [RISING PHARMA HOLDINGS, INC.]10Current NDC, Legacy NDC, 6 package rows20250520_2ed21930-1e05-46de-8acd-cb6f4798a7fa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1992303timolol 0.5 % 12HR Ophthalmic SolutionPSN2ed21930-1e05-46de-8acd-cb6f4798a7fa10
1923428timolol maleate 0.25 % Ophthalmic SolutionPSN2ed21930-1e05-46de-8acd-cb6f4798a7fa10
199230312 HR timolol 5 MG/ML Ophthalmic SolutionSCD2ed21930-1e05-46de-8acd-cb6f4798a7fa10
1923428timolol 2.5 MG/ML Ophthalmic SolutionSCD2ed21930-1e05-46de-8acd-cb6f4798a7fa10
1923428timolol 0.25 % Ophthalmic SolutionSY2ed21930-1e05-46de-8acd-cb6f4798a7fa10
1992303timolol 0.5 % (as timolol maleate 6.8 MG/ML) 12 HR Ophthalmic SolutionSY2ed21930-1e05-46de-8acd-cb6f4798a7fa10
1992303timolol 0.5 % 12 HR Ophthalmic SolutionSY2ed21930-1e05-46de-8acd-cb6f4798a7fa10
1923428timolol 2.5 MG/ML (as timolol maleate 3.4 MG/ML) Ophthalmic SolutionSY2ed21930-1e05-46de-8acd-cb6f4798a7fa10
1992303timolol 0.5 % 12HR Ophthalmic SolutionPSN9fd81371-caca-44c3-bd1d-d095b26a02412
199230312 HR timolol 5 MG/ML Ophthalmic SolutionSCD9fd81371-caca-44c3-bd1d-d095b26a02412
1992303timolol 0.5 % (as timolol maleate 6.8 MG/ML) 12 HR Ophthalmic SolutionSY9fd81371-caca-44c3-bd1d-d095b26a02412
1992303timolol 0.5 % 12 HR Ophthalmic SolutionSY9fd81371-caca-44c3-bd1d-d095b26a02412
1992303timolol 0.5 % 12HR Ophthalmic SolutionPSNb41b1b81-5d8c-48a9-e053-2a95a90a6ef61
199230312 HR timolol 5 MG/ML Ophthalmic SolutionSCDb41b1b81-5d8c-48a9-e053-2a95a90a6ef61
1992303timolol 0.5 % (as timolol maleate 6.8 MG/ML) 12 HR Ophthalmic SolutionSYb41b1b81-5d8c-48a9-e053-2a95a90a6ef61
1992303timolol 0.5 % 12 HR Ophthalmic SolutionSYb41b1b81-5d8c-48a9-e053-2a95a90a6ef61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64980-514-01649800514011 BOTTLE in 1 CARTON (64980-514-01) / 10 mL in 1 BOTTLE1 bottle2014-12-150000-00-00NoNoCurrent
64980-514-05649800514051 BOTTLE in 1 CARTON (64980-514-05) / 5 mL in 1 BOTTLE1 bottle2014-12-150000-00-00NoNoCurrent
64980-514-15649800514151 BOTTLE in 1 CARTON (64980-514-15) / 15 mL in 1 BOTTLE1 bottle2014-12-150000-00-00NoNoCurrent