Home NDC 68682-045-25 Timolol Maleate
Product NDC 68682-045
Requested package NDC 68682-045-25
11-digit product format 686820045
Labeler code 68682
Product ID 68682-045_4fe86cd0-e1e4-e99c-e063-6294a90a2f03
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Timolol Maleate
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Oceanside Pharmaceuticals
Application NDA021516
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2018-05-30
Marketing end 2026-08-31
Substance TIMOLOL MALEATE
Active strength 5 mg/mL
Pharmacologic classes Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag No
Current FDA listing Yes 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 N021516-001 ISTALOL TIMOLOL MALEATE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2004-06-04
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021516-001 AT2
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 N021516-001 ISTALOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2004-06-04 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 N021516-001 AT2 1 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 3 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Timolol Maleate Active Ingredients# Ingredient, Strength table Ingredient Strength TIMOLOL MALEATE 5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination P8Y54F701R Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1992299 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 68682-045-25 Timolol Maleate 2.5 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 2.5 3 68682-045-25 Timolol Maleate 1 in 1 CARTON SOLUTION/ DROPS 1 3 68682-045-50 Timolol Maleate 1 in 1 CARTON SOLUTION/ DROPS 1 3 68682-045-50 Timolol Maleate 5 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 5 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68682-045 TIMOLOL MALEATE SOLUTION/ DROPS [OCEANSIDE PHARMACEUTICALS] 2 Current NDC, Legacy NDC, 4 package rows 20200124_3c20b537-88c6-4ec7-a359-e0ba67afe431.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 68682-045-25 68682004525 1 BOTTLE, DROPPER in 1 CARTON (68682-045-25) / 2.5 mL in 1 BOTTLE, DROPPER 2018-05-30 2026-08-31 No No Current