Home NDC 82260-818-25 Timolol Maleate
Product NDC 82260-818
Requested package NDC 82260-818-25
11-digit product format 822600818
Labeler code 82260
Product ID 82260-818_31420e86-ee3b-e6b1-e063-6394a90aefc7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Timolol Maleate
Dosage form SOLUTION
Route OPHTHALMIC
Labeler Bausch & Lomb Americas Inc.
Application NDA020330
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2018-02-14
Substance TIMOLOL MALEATE
Active strength 2.5 mg/mL
Pharmacologic classes Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
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 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020330-001 TIMOPTIC-XE TIMOLOL MALEATE EQ 0.25% BASE SOLUTION, GEL FORMING/DROPS / OPHTHALMIC AB RLD 1993-11-04 N020330-002 TIMOPTIC-XE TIMOLOL MALEATE EQ 0.5% BASE SOLUTION, GEL FORMING/DROPS / OPHTHALMIC AB RLD 1993-11-04
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 N020330-001 TIMOPTIC-XE EQ 0.25% BASE SOLUTION, GEL FORMING/DROPS / OPHTHALMIC AB RLD 1993-11-04 a50c72e98297…2026-08-01 22:54:32 2026-06 N020330-002 TIMOPTIC-XE EQ 0.5% BASE SOLUTION, GEL FORMING/DROPS / OPHTHALMIC AB RLD 1993-11-04 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 N020330-001 AB 1 a50c72e98297…2026-08-01 22:54:32 2026-06 N020330-002 AB 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 · 2 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Timolol Maleate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TIMOLOL MALEATE 2.5 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 313407 Internal RxNorm lookup 313408 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 82260-818-25 Timolol Maleate 5 mL in 1 BOTTLE, DISPENSING SOLUTION 5 4 82260-818-25 Timolol Maleate 1 in 1 CARTON SOLUTION 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82260-818 TIMOLOL MALEATE SOLUTION [BAUSCH & LOMB AMERICAS INC.] 4 Current NDC, Legacy NDC, 2 package rows 20250328_581f80f7-4419-49e2-867d-40443c75409f.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 82260-818-25 82260081825 1 BOTTLE, DISPENSING in 1 CARTON (82260-818-25) / 5 mL in 1 BOTTLE, DISPENSING 2018-02-14 0000-00-00 No No Current