Home NDC 60758-802 TIMOLOL MALEATE
Product NDC 60758-802
11-digit product format 607580802
Labeler code 60758
Product ID 60758-802_27ed7b7d-7640-4566-90f3-42a17a9d1a98
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name timolol maleate
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Pacific Pharma, Inc.
Application ANDA074746
Marketing category ANDA
Marketing start 1997-05-20
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 2027-12-31
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 A074746-001 TIMOLOL MALEATE TIMOLOL MALEATE EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT1 1997-03-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A074746-001 AT1
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 A074746-001 TIMOLOL MALEATE EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT1 1997-03-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A074746-001 TIMOLOL MALEATE EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT1 1997-03-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074746-001 TIMOLOL MALEATE EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT1 1997-03-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074746-001 TIMOLOL MALEATE EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT1 1997-03-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074746-001 TIMOLOL MALEATE EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT1 1997-03-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074746-001 TIMOLOL MALEATE EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT1 1997-03-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074746-001 TIMOLOL MALEATE EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT1 1997-03-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074746-001 TIMOLOL MALEATE EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT1 1997-03-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074746-001 TIMOLOL MALEATE EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT1 1997-03-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074746-001 TIMOLOL MALEATE EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT1 1997-03-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074746-001 TIMOLOL MALEATE EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT1 1997-03-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074746-001 TIMOLOL MALEATE EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT1 1997-03-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074746-001 TIMOLOL MALEATE EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT1 1997-03-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074746-001 TIMOLOL MALEATE EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT1 1997-03-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074746-001 TIMOLOL MALEATE EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT1 1997-03-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074746-001 TIMOLOL MALEATE EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT1 1997-03-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074746-001 TIMOLOL MALEATE EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT1 1997-03-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074746-001 TIMOLOL MALEATE EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT1 1997-03-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074746-001 TIMOLOL MALEATE EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT 1997-03-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074746-001 TIMOLOL MALEATE EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT1 1997-03-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074746-001 TIMOLOL MALEATE EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT 1997-03-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A074746-001 TIMOLOL MALEATE EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT 1997-03-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A074746-001 TIMOLOL MALEATE EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT 1997-03-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A074746-001 TIMOLOL MALEATE EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT 1997-03-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A074746-001 TIMOLOL MALEATE EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT 1997-03-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A074746-001 TIMOLOL MALEATE EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT 1997-03-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A074746-001 TIMOLOL MALEATE EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT 1997-03-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A074746-001 TIMOLOL MALEATE EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT 1997-03-25 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A074746-001 TIMOLOL MALEATE EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT1 1997-03-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A074746-001 TIMOLOL MALEATE EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT1 1997-03-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A074746-001 TIMOLOL MALEATE EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT1 1997-03-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A074746-001 TIMOLOL MALEATE EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT1 1997-03-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A074746-001 TIMOLOL MALEATE EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT1 1997-03-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A074746-001 TIMOLOL MALEATE EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT1 1997-03-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A074746-001 TIMOLOL MALEATE EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT1 1997-03-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A074746-001 TIMOLOL MALEATE EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT1 1997-03-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A074746-001 TIMOLOL MALEATE EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT1 1997-03-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A074746-001 TIMOLOL MALEATE EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT1 1997-03-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A074746-001 TIMOLOL MALEATE EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT1 1997-03-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A074746-001 TIMOLOL MALEATE EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT1 1997-03-25 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
Listing expiration 2027-12-31 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 1923428 Internal RxNorm lookup 1992303 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 60758-802-05 TIMOLOL MALEATE 1 in 1 CARTON SOLUTION/ DROPS 1 16 60758-802-05 TIMOLOL MALEATE 5 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 5 16 60758-802-10 TIMOLOL MALEATE 10 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 10 16 60758-802-10 TIMOLOL MALEATE 1 in 1 CARTON SOLUTION/ DROPS 1 16
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded timolol maleate ACTIVE INGREDIENT P8Y54F701R TIMOLOL MALEATE (TIMOLOL MALEATE) SOLUTION/ DROPS [PACIFIC PHARMA, INC.
] 8 timolol anhydrous ACTIVE MOIETY 5JKY92S7BR TIMOLOL MALEATE (TIMOLOL MALEATE) SOLUTION/ DROPS [PACIFIC PHARMA, INC.
] 8 benzalkonium chloride INACTIVE INGREDIENT F5UM2KM3W7 TIMOLOL MALEATE (TIMOLOL MALEATE) SOLUTION/ DROPS [PACIFIC PHARMA, INC.
] 8 hydrochloric acid INACTIVE INGREDIENT QTT17582CB TIMOLOL MALEATE (TIMOLOL MALEATE) SOLUTION/ DROPS [PACIFIC PHARMA, INC.
] 8 sodium hydroxide INACTIVE INGREDIENT 55X04QC32I TIMOLOL MALEATE (TIMOLOL MALEATE) SOLUTION/ DROPS [PACIFIC PHARMA, INC.
] 8 sodium phosphate, dibasic INACTIVE INGREDIENT GR686LBA74 TIMOLOL MALEATE (TIMOLOL MALEATE) SOLUTION/ DROPS [PACIFIC PHARMA, INC.
] 8 sodium phosphate, monobasic INACTIVE INGREDIENT 3980JIH2SW TIMOLOL MALEATE (TIMOLOL MALEATE) SOLUTION/ DROPS [PACIFIC PHARMA, INC.
] 8 water INACTIVE INGREDIENT 059QF0KO0R TIMOLOL MALEATE (TIMOLOL MALEATE) SOLUTION/ DROPS [PACIFIC PHARMA, INC.
] 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60758-802 TIMOLOL MALEATE SOLUTION/ DROPS [PACIFIC PHARMA, INC.] 15 Current NDC, Legacy NDC, 4 package rows 20240404_e16c33fd-aa86-49ad-a767-c79ade4a62c7.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 Marketing start Marketing end Sample Exclude flag Status 60758-802-05 60758080205 1 BOTTLE, DROPPER in 1 CARTON (60758-802-05) / 5 mL in 1 BOTTLE, DROPPER 1997-05-20 0000-00-00 No No Current 60758-802-10 60758080210 1 BOTTLE, DROPPER in 1 CARTON (60758-802-10) / 10 mL in 1 BOTTLE, DROPPER 1997-05-20 0000-00-00 No No Current