Home NDC 72485-602 Timolol maleate
Product NDC 72485-602
11-digit product format 724850602
Labeler code 72485
Product ID 72485-602_9173b81c-8ae8-4b3b-a0b8-2530a1462616
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Timolol maleate
Dosage form SOLUTION
Route OPHTHALMIC
Labeler Armas Pharmaceuticals, Inc.
Application ANDA217195
Marketing category ANDA
Marketing start 2023-05-08
Substance TIMOLOL MALEATE
Active strength 6.8 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 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 A217195-001 TIMOLOL MALEATE TIMOLOL MALEATE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT3 2023-05-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217195-001 AT3
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 A217195-001 TIMOLOL MALEATE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT3 2023-05-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A217195-001 TIMOLOL MALEATE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT3 2023-05-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217195-001 TIMOLOL MALEATE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT3 2023-05-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217195-001 TIMOLOL MALEATE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT3 2023-05-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217195-001 TIMOLOL MALEATE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT3 2023-05-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217195-001 TIMOLOL MALEATE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT3 2023-05-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217195-001 TIMOLOL MALEATE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT3 2023-05-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217195-001 TIMOLOL MALEATE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT3 2023-05-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217195-001 TIMOLOL MALEATE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT3 2023-05-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217195-001 TIMOLOL MALEATE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT3 2023-05-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217195-001 TIMOLOL MALEATE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT3 2023-05-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217195-001 TIMOLOL MALEATE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT3 2023-05-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217195-001 TIMOLOL MALEATE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT3 2023-05-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217195-001 TIMOLOL MALEATE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT3 2023-05-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A217195-001 TIMOLOL MALEATE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT3 2023-05-08 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A217195-001 TIMOLOL MALEATE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT3 2023-05-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A217195-001 TIMOLOL MALEATE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT3 2023-05-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A217195-001 TIMOLOL MALEATE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT3 2023-05-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A217195-001 TIMOLOL MALEATE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT3 2023-05-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A217195-001 TIMOLOL MALEATE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT3 2023-05-08 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A217195-001 TIMOLOL MALEATE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT3 2023-05-08 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A217195-001 TIMOLOL MALEATE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT3 2023-05-08 3f0d92c62455…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217195-001 TIMOLOL MALEATE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT3 2023-05-08 a50c72e98297…
Observed Orange Book normalized TE history# 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 6.8 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 1922894 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 72485-602-05 Timolol maleate 0.3 mL in 1 VIAL SOLUTION 0.3 3 72485-602-05 Timolol maleate 10 in 1 POUCH SOLUTION 10 3 72485-602-60 Timolol maleate 6 in 1 CARTON SOLUTION 6 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72485-602 TIMOLOL MALEATE SOLUTION [ARMAS PHARMACEUTICALS, INC.] 2 Current NDC, 3 package rows 20241215_ea585fe8-3356-4f08-8078-34e8ab5de37e.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 72485-602-05 72485060205 0.3 mL in 1 VIAL 0.3 ml Historical 72485-602-60 72485060260 6 POUCH in 1 CARTON (72485-602-60) / 10 VIAL in 1 POUCH (72485-602-05) / .3 mL in 1 VIAL 6 pouch 2023-05-08 No No Current