FDA.reportPublic FDA data

Timolol Maleate Ophthalmic Gel Forming Solution

Product NDC
72266-200
11-digit product format
722660200
Labeler code
72266
Product ID
72266-200_3a229bef-de33-9ec4-e063-6394a90ad1b7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Timolol Maleate Ophthalmic Gel Forming Solution
Dosage form
SOLUTION, GEL FORMING / DROPS
Route
OPHTHALMIC
Labeler
FOSUN PHARMA USA INC
Application
ANDA214645
Marketing category
ANDA
Marketing start
2023-03-15
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 Ophthalmic Gel Forming Solution
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TIMOLOL MALEATE5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiP8Y54F701R
Rxcui313407, 313408

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6c0c444-a6ba-2fb5-a7bc-7f0443fa5791Product name420251208
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
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
72266-200-01Timolol Maleate Ophthalmic Gel Forming Solution5 mL in 1 BOTTLESOLUTION, GEL FORMING / DROPS56
72266-200-01Timolol Maleate Ophthalmic Gel Forming Solution1 in 1 CARTONSOLUTION, GEL FORMING / DROPS16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72266-200-01ML - Milliliter72266-2001dace5fd-edf4-4ff5-86bd-2e7524768e9112023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72266-200TIMOLOL MALEATE OPHTHALMIC GEL FORMING SOLUTION SOLUTION, GEL FORMING / DROPS [FOSUN PHARMA USA INC]5Current NDC, 2 package rows20250323_e93036c6-3120-e989-e053-2a95a90acf7f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313407timolol maleate 0.25 % Ophthalmic Gel Forming SolutionPSNe93036c6-3120-e989-e053-2a95a90acf7f6
313408timolol maleate 0.5 % Ophthalmic Gel Forming SolutionPSNe93036c6-3120-e989-e053-2a95a90acf7f6
313407timolol 0.0025 MG/MG Ophthalmic GelSCDe93036c6-3120-e989-e053-2a95a90acf7f6
313408timolol 0.005 MG/MG Ophthalmic GelSCDe93036c6-3120-e989-e053-2a95a90acf7f6
313407timolol 0.25 % Ophthalmic GelSYe93036c6-3120-e989-e053-2a95a90acf7f6
313407timolol 0.25 % Ophthalmic Gel Forming SolutionSYe93036c6-3120-e989-e053-2a95a90acf7f6
313408timolol 0.5 % (as timolol maleate 6.8 MG/ML) Ophthalmic GelSYe93036c6-3120-e989-e053-2a95a90acf7f6
313408timolol 0.5 % Gel Forming Ophthalmic SolutionSYe93036c6-3120-e989-e053-2a95a90acf7f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72266-200-01722660200011 BOTTLE in 1 CARTON (72266-200-01) / 5 mL in 1 BOTTLE1 bottle2023-03-15NoNoHistorical