FDA.reportPublic FDA data

Timolol maleate

Product NDC
72485-602
11-digit product format
724850602
Labeler code
72485
Product ID
72485-602_9173b81c-8ae8-4b3b-a0b8-2530a1462616
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Timolol maleate
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Armas Pharmaceuticals, Inc.
Application
ANDA217195
Marketing category
ANDA
Marketing start
2023-05-08
Substance
TIMOLOL MALEATE
Active strength
6.8 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 MALEATE6.8 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiP8Y54F701R
Rxcui1922894

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
72485-602-05Timolol maleate0.3 mL in 1 VIALSOLUTION0.33
72485-602-05Timolol maleate10 in 1 POUCHSOLUTION103
72485-602-60Timolol maleate6 in 1 CARTONSOLUTION63

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72485-602-05EA - Each72485-602c207e5bc-5811-41e6-986b-d0938414400e12023-07-06
72485-602-60EA - Each72485-602ab3570b0-19b0-4e35-aa80-880cfef53f6912023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72485-602TIMOLOL MALEATE SOLUTION [ARMAS PHARMACEUTICALS, INC.]2Current NDC, 3 package rows20241215_ea585fe8-3356-4f08-8078-34e8ab5de37e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1922894timolol PF 0.5 % Ophthalmic SolutionPSNea585fe8-3356-4f08-8078-34e8ab5de37e3
1922894Preservative-Free timolol 5 MG/ML Ophthalmic SolutionSCDea585fe8-3356-4f08-8078-34e8ab5de37e3
1922894timolol PF 0.5 % Ophthalmic SolutionSYea585fe8-3356-4f08-8078-34e8ab5de37e3
1922894timolol PF 5 MG/ML (as timolol maleate 6.8 MG/ML) Ophthalmic SolutionSYea585fe8-3356-4f08-8078-34e8ab5de37e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72485-602-05724850602050.3 mL in 1 VIAL0.3 mlHistorical
72485-602-60724850602606 POUCH in 1 CARTON (72485-602-60) / 10 VIAL in 1 POUCH (72485-602-05) / .3 mL in 1 VIAL6 pouch2023-05-08NoNoHistorical