Home NDC 68682-045 Timolol Maleate
Product NDC 68682-045
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 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 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.
Product history page 1 of 2 · 42 observed 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 N021516-001 ISTALOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2004-06-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021516-001 ISTALOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2004-06-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021516-001 ISTALOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2004-06-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021516-001 ISTALOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2004-06-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021516-001 ISTALOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2004-06-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021516-001 ISTALOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2004-06-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021516-001 ISTALOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2004-06-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021516-001 ISTALOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2004-06-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021516-001 ISTALOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2004-06-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021516-001 ISTALOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2004-06-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021516-001 ISTALOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2004-06-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021516-001 ISTALOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2004-06-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021516-001 ISTALOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2004-06-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021516-001 ISTALOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2004-06-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021516-001 ISTALOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2004-06-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021516-001 ISTALOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2004-06-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021516-001 ISTALOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2004-06-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021516-001 ISTALOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2004-06-04 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021516-001 ISTALOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2004-06-04 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021516-001 ISTALOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2004-06-04 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021516-001 ISTALOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2004-06-04 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021516-001 ISTALOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2004-06-04 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021516-001 ISTALOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2004-06-04 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021516-001 ISTALOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2004-06-04 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021516-001 ISTALOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2004-06-04 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021516-001 ISTALOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2004-06-04 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021516-001 ISTALOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2004-06-04 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021516-001 ISTALOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2004-06-04 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021516-001 ISTALOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2004-06-04 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021516-001 ISTALOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2004-06-04 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021516-001 ISTALOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2004-06-04 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021516-001 ISTALOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2004-06-04 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021516-001 ISTALOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2004-06-04 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021516-001 ISTALOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2004-06-04 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021516-001 ISTALOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2004-06-04 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021516-001 ISTALOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2004-06-04 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021516-001 ISTALOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2004-06-04 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021516-001 ISTALOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2004-06-04 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021516-001 ISTALOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2004-06-04 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021516-001 ISTALOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2004-06-04 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
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
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 · 3 matching rows.
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 68682-045-50 68682004550 1 BOTTLE, DROPPER in 1 CARTON (68682-045-50) > 5 mL in 1 BOTTLE, DROPPER 2018-05-30 0000-00-00 No No Current