Home NDC 50090-1247-0 Dorzolamide Hydrochloride and Timolol Maleate
Product NDC 50090-1247
Requested package NDC 50090-1247-0
11-digit product format 500901247
Labeler code 50090
Product ID 50090-1247_65bf8a17-f975-4324-9690-39a498cf5c17
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dorzolamide Hydrochloride and Timolol Maleate
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler A-S Medication Solutions
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…
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 50090-1247-0 50090124700 1 BOTTLE, DROPPER in 1 BOX (50090-1247-0) > 10 mL in 1 BOTTLE, DROPPER 2014-11-28 0000-00-00 No No Current