Home NDC 60429-115-10 Dorzolamide Hydrochloride and Timolol Maleate
Product NDC 60429-115
Requested package NDC 60429-115-10
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 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A077847-001 DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE EQ 2% BASE;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC 2008-10-28
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 A077847-001 DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE EQ 2% BASE;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC 2008-10-28 a50c72e98297…
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DORZOLAMIDE HYDROCHLORIDE ACTIVE INGREDIENT QZO5366EW7 DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 TIMOLOL MALEATE ACTIVE INGREDIENT P8Y54F701R DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 DORZOLAMIDE ACTIVE MOIETY 9JDX055TW1 DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 TIMOLOL ANHYDROUS ACTIVE MOIETY 5JKY92S7BR DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 BENZALKONIUM CHLORIDE INACTIVE INGREDIENT F5UM2KM3W7 DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) INACTIVE INGREDIENT S38J6RZN16 DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 MANNITOL INACTIVE INGREDIENT 3OWL53L36A DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [GOLDEN STATE MEDICAL SUPPLY, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60429-115 DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [GOLDEN STATE MEDICAL SUPPLY, INC.] 16 Legacy NDC 20240127_a5c104e7-4d99-49ec-80bf-eccea69b4c79.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 60429-115-10 60429011510 1 BOTTLE, DROPPER in 1 BOX (60429-115-10) > 10 mL in 1 BOTTLE, DROPPER 2015-03-20 0000-00-00 No No Current