FDA.reportPublic FDA data

Dorzolamide Hydrochloride and Timolol Maleate

Product NDC
60429-115
11-digit product format
604290115
Labeler code
60429
Product ID
60429-115_e54a8f65-d992-3e40-e053-2995a90a26fd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dorzolamide Hydrochloride and Timolol Maleate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Golden State Medical Supply, Inc.
Application
ANDA077847
Marketing category
ANDA
Marketing start
2008-10-28
Marketing end
0000-00-00
Substance
DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE
Active strength
20 mg/mL; mg/mL
Pharmacologic classes
Adrenergic beta-Antagonists [MoA], Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct60429-115DDiscontinued by firm2026-07-31
excluded packagepackage60429-11560429-115-10DDiscontinued 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
A077847-001DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEDORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATEEQ 2% BASE;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMIC2008-10-28

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 22:54:322026-06A077847-001DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEEQ 2% BASE;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMIC2008-10-28a50c72e98297…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60429-115-10ML - Milliliter60429-1150ad65751-bb34-42d7-a725-5cafb1583c1412015-08-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DORZOLAMIDE HYDROCHLORIDEACTIVE INGREDIENTQZO5366EW7DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [GOLDEN STATE MEDICAL SUPPLY, INC.]1
TIMOLOL MALEATEACTIVE INGREDIENTP8Y54F701RDORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [GOLDEN STATE MEDICAL SUPPLY, INC.]1
DORZOLAMIDEACTIVE MOIETY9JDX055TW1DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [GOLDEN STATE MEDICAL SUPPLY, INC.]1
TIMOLOL ANHYDROUSACTIVE MOIETY5JKY92S7BRDORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [GOLDEN STATE MEDICAL SUPPLY, INC.]1
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [GOLDEN STATE MEDICAL SUPPLY, INC.]1
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)INACTIVE INGREDIENTS38J6RZN16DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [GOLDEN STATE MEDICAL SUPPLY, INC.]1
MANNITOLINACTIVE INGREDIENT3OWL53L36ADORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [GOLDEN STATE MEDICAL SUPPLY, INC.]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRDORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [GOLDEN STATE MEDICAL SUPPLY, INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IDORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [GOLDEN STATE MEDICAL SUPPLY, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RDORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [GOLDEN STATE MEDICAL SUPPLY, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60429-115DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [GOLDEN STATE MEDICAL SUPPLY, INC.]16Legacy NDC20240127_a5c104e7-4d99-49ec-80bf-eccea69b4c79.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60429-115-10604290115101 BOTTLE, DROPPER in 1 BOX (60429-115-10) > 10 mL in 1 BOTTLE, DROPPER2015-03-200000-00-00NoNoCurrent