Home NDC 50090-1852 TIMOLOL MALEATE
Product NDC 50090-1852
11-digit product format 500901852
Labeler code 50090
Product ID 50090-1852_7506af7c-3efd-4d0f-8a33-3dd8dc486935
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name timolol maleate
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler A-S Medication Solutions
Application ANDA077259
Marketing category ANDA
Marketing start 2014-12-15
Marketing end 0000-00-00
Substance TIMOLOL MALEATE
Active strength 5 mg/mL
Pharmacologic classes Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC exclude flag No
Listing certified through 2019-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 50090-1852-0 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 50090-1852-0 f5e01cc5f278…a2eaf40c39c3…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A077259-001 TIMOLOL MALEATE TIMOLOL MALEATE EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT1 2008-04-30 A077259-002 TIMOLOL MALEATE TIMOLOL MALEATE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT1 2008-04-30
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.
Product history page 1 of 3 · 84 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 A077259-001 TIMOLOL MALEATE EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT1 2008-04-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077259-002 TIMOLOL MALEATE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT1 2008-04-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077259-001 TIMOLOL MALEATE EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT1 2008-04-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077259-002 TIMOLOL MALEATE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT1 2008-04-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077259-001 TIMOLOL MALEATE EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT1 2008-04-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077259-002 TIMOLOL MALEATE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT1 2008-04-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077259-001 TIMOLOL MALEATE EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT1 2008-04-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077259-002 TIMOLOL MALEATE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT1 2008-04-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077259-001 TIMOLOL MALEATE EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT1 2008-04-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077259-002 TIMOLOL MALEATE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT1 2008-04-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077259-001 TIMOLOL MALEATE EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT1 2008-04-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077259-002 TIMOLOL MALEATE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT1 2008-04-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077259-001 TIMOLOL MALEATE EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT1 2008-04-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077259-002 TIMOLOL MALEATE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT1 2008-04-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077259-001 TIMOLOL MALEATE EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT1 2008-04-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077259-002 TIMOLOL MALEATE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT1 2008-04-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077259-001 TIMOLOL MALEATE EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT1 2008-04-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077259-002 TIMOLOL MALEATE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT1 2008-04-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077259-001 TIMOLOL MALEATE EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT1 2008-04-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077259-002 TIMOLOL MALEATE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT1 2008-04-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077259-001 TIMOLOL MALEATE EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT1 2008-04-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077259-002 TIMOLOL MALEATE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT1 2008-04-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077259-001 TIMOLOL MALEATE EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT1 2008-04-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077259-002 TIMOLOL MALEATE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT1 2008-04-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077259-001 TIMOLOL MALEATE EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT1 2008-04-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077259-002 TIMOLOL MALEATE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT1 2008-04-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077259-001 TIMOLOL MALEATE EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT1 2008-04-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077259-002 TIMOLOL MALEATE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT1 2008-04-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077259-001 TIMOLOL MALEATE EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT1 2008-04-30 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A077259-002 TIMOLOL MALEATE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT1 2008-04-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077259-001 TIMOLOL MALEATE EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT1 2008-04-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077259-002 TIMOLOL MALEATE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT1 2008-04-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077259-001 TIMOLOL MALEATE EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT1 2008-04-30 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A077259-002 TIMOLOL MALEATE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT1 2008-04-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077259-001 TIMOLOL MALEATE EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT1 2008-04-30 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A077259-002 TIMOLOL MALEATE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT1 2008-04-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077259-001 TIMOLOL MALEATE EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT 2008-04-30 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A077259-002 TIMOLOL MALEATE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT1 2008-04-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077259-001 TIMOLOL MALEATE EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT1 2008-04-30 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A077259-002 TIMOLOL MALEATE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT1 2008-04-30 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
Additional Listing Data#
Finished product Yes
Brand name base TIMOLOL MALEATE
Listing expiration 2027-12-31 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 SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-1852 TIMOLOL MALEATE SOLUTION/ DROPS [A-S MEDICATION SOLUTIONS] 16 Legacy NDC 20230706_64561dfd-3704-4820-aef6-d0d26cef7255.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Status 50090-1852-0 50090185200 1 BOTTLE in 1 CARTON (50090-1852-0) / 10 mL in 1 BOTTLE 1 bottle 2015-06-01 0 Current