FDA.reportPublic FDA data

Timolol Maleate

Product NDC
50383-021
Requested package NDC
50383-021-05
11-digit product format
503830021
Labeler code
50383
Product ID
50383-021_66806aed-f023-4e82-98b5-fd361bf15afe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Timolol Maleate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Akorn
Application
ANDA075163
Marketing category
ANDA
Marketing start
2002-09-10
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
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50383-02150383-021-05DDiscontinued by firm2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075163-001TIMOLOL MALEATETIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMIC2002-09-10

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A075163-001TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMIC2002-09-10a50c72e98297…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50383-021-05ML - Milliliter50383-02146305671-33ce-45e7-a003-b7330372adaf12012-07-24
50383-021-10ML - Milliliter50383-021f231c7a3-1392-46c1-be49-fe52f2df2e8f12012-07-24
50383-021-15ML - Milliliter50383-02143470d9f-6d79-4719-b0f7-703472eeb1d112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TIMOLOL MALEATEACTIVE INGREDIENTP8Y54F701RTIMOLOL MALEATE SOLUTION/ DROPS [HI-TECH PHARMACAL CO., INC.]4
TIMOLOL ANHYDROUSACTIVE MOIETY5JKY92S7BRTIMOLOL MALEATE SOLUTION/ DROPS [HI-TECH PHARMACAL CO., INC.]4
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7TIMOLOL MALEATE SOLUTION/ DROPS [HI-TECH PHARMACAL CO., INC.]4
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74TIMOLOL MALEATE SOLUTION/ DROPS [HI-TECH PHARMACAL CO., INC.]4
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWTIMOLOL MALEATE SOLUTION/ DROPS [HI-TECH PHARMACAL CO., INC.]4
WATERINACTIVE INGREDIENT059QF0KO0RTIMOLOL MALEATE SOLUTION/ DROPS [HI-TECH PHARMACAL CO., INC.]4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50383-021-05503830021051 BOTTLE in 1 CARTON (50383-021-05) > 5 mL in 1 BOTTLE1 bottle2002-09-100000-00-00NoNoCurrent