Home NDC 70069-501 Dorzolamide Hydrochloride
Product NDC 70069-501
11-digit product format 700690501
Labeler code 70069
Product ID 70069-501_599cbb55-78b6-467b-8762-fe20c11b013e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dorzolamide Hydrochloride
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Somerset Therapeutics, LLC
Application ANDA215004
Marketing category ANDA
Marketing start 2025-02-12
Substance DORZOLAMIDE HYDROCHLORIDE
Active strength 20 mg/mL
Pharmacologic classes Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A215004-001 DORZOLAMIDE HYDROCHLORIDE DORZOLAMIDE HYDROCHLORIDE EQ 2% BASE SOLUTION/DROPS / OPHTHALMIC AT 2025-02-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215004-001 AT
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 2026-08-18 06:07:40 2026-07 A215004-001 DORZOLAMIDE HYDROCHLORIDE EQ 2% BASE SOLUTION/DROPS / OPHTHALMIC AT 2025-02-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A215004-001 DORZOLAMIDE HYDROCHLORIDE EQ 2% BASE SOLUTION/DROPS / OPHTHALMIC AT 2025-02-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215004-001 DORZOLAMIDE HYDROCHLORIDE EQ 2% BASE SOLUTION/DROPS / OPHTHALMIC AT 2025-02-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215004-001 DORZOLAMIDE HYDROCHLORIDE EQ 2% BASE SOLUTION/DROPS / OPHTHALMIC AT 2025-02-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215004-001 DORZOLAMIDE HYDROCHLORIDE EQ 2% BASE SOLUTION/DROPS / OPHTHALMIC AT 2025-02-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215004-001 DORZOLAMIDE HYDROCHLORIDE EQ 2% BASE SOLUTION/DROPS / OPHTHALMIC AT 2025-02-11 b8a1b40f171c…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215004-001 DORZOLAMIDE HYDROCHLORIDE EQ 2% BASE SOLUTION/DROPS / OPHTHALMIC AT 2025-02-11 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Dorzolamide Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DORZOLAMIDE HYDROCHLORIDE 20 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination QZO5366EW7 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 310015 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70069-501-01 Dorzolamide Hydrochloride 10 mL in 1 BOTTLE SOLUTION/ DROPS 10 6 70069-501-01 Dorzolamide Hydrochloride 1 in 1 CARTON SOLUTION/ DROPS 1 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70069-501 DORZOLAMIDE HYDROCHLORIDE SOLUTION/ DROPS [SOMERSET THERAPEUTICS, LLC] 6 Current NDC, 2 package rows 20250214_0832960f-0a6f-4fd1-bf55-be9bebde53bd.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70069-501-01 70069050101 1 BOTTLE in 1 CARTON (70069-501-01) / 10 mL in 1 BOTTLE 1 bottle 2025-02-12 No No Current