Home NDC 64980-513 TIMOLOL MALEATE
Product NDC 64980-513
11-digit product format 649800513
Labeler code 64980
Product ID 64980-513_ce38c2fa-e404-40e3-b684-8c31a58245be
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name timolol maleate
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Rising Pharma Holdings, Inc.
Application ANDA077259
Marketing category ANDA
Marketing start 2014-12-15
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 43 .
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 · 86 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 2026-09-14 22:38:34 2026-08 A077259-001 TIMOLOL MALEATE EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT1 2008-04-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077259-002 TIMOLOL MALEATE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT1 2008-04-30 84e616aacf4f…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 64980-513-01 TIMOLOL MALEATE 10 mL in 1 BOTTLE SOLUTION/ DROPS 10 10 64980-513-01 TIMOLOL MALEATE 1 in 1 CARTON SOLUTION/ DROPS 1 10 64980-513-05 TIMOLOL MALEATE 1 in 1 CARTON SOLUTION/ DROPS 1 10 64980-513-05 TIMOLOL MALEATE 5 mL in 1 BOTTLE SOLUTION/ DROPS 5 10 64980-513-15 TIMOLOL MALEATE 1 in 1 CARTON SOLUTION/ DROPS 1 10 64980-513-15 TIMOLOL MALEATE 15 mL in 1 BOTTLE SOLUTION/ DROPS 15 10
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded TIMOLOL MALEATE ACTIVE INGREDIENT P8Y54F701R TIMOLOL MALEATE SOLUTION/ DROPS [RISING PHARMACEUTICALS, INC.] 1 TIMOLOL ANHYDROUS ACTIVE MOIETY 5JKY92S7BR TIMOLOL MALEATE SOLUTION/ DROPS [RISING PHARMACEUTICALS, INC.] 1 BENZALKONIUM CHLORIDE INACTIVE INGREDIENT F5UM2KM3W7 TIMOLOL MALEATE SOLUTION/ DROPS [RISING PHARMACEUTICALS, INC.] 1 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X TIMOLOL MALEATE SOLUTION/ DROPS [RISING PHARMACEUTICALS, INC.] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I TIMOLOL MALEATE SOLUTION/ DROPS [RISING PHARMACEUTICALS, INC.] 1 SODIUM PHOSPHATE, DIBASIC INACTIVE INGREDIENT GR686LBA74 TIMOLOL MALEATE SOLUTION/ DROPS [RISING PHARMACEUTICALS, INC.] 1 SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATE INACTIVE INGREDIENT E1W4N241FO TIMOLOL MALEATE SOLUTION/ DROPS [RISING PHARMACEUTICALS, INC.] 1 SODIUM PHOSPHATE, MONOBASIC INACTIVE INGREDIENT 3980JIH2SW TIMOLOL MALEATE SOLUTION/ DROPS [RISING PHARMACEUTICALS, INC.] 1 SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE INACTIVE INGREDIENT 5QWK665956 TIMOLOL MALEATE SOLUTION/ DROPS [RISING PHARMACEUTICALS, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R TIMOLOL MALEATE SOLUTION/ DROPS [RISING PHARMACEUTICALS, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64980-513 TIMOLOL MALEATE SOLUTION/ DROPS [RISING PHARMA HOLDINGS, INC.] 10 Current NDC, Legacy NDC, 6 package rows 20250520_2ed21930-1e05-46de-8acd-cb6f4798a7fa.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 64980-513-01 64980051301 1 BOTTLE in 1 CARTON (64980-513-01) / 10 mL in 1 BOTTLE 1 bottle 2014-12-15 0000-00-00 No No Current 64980-513-05 64980051305 1 BOTTLE in 1 CARTON (64980-513-05) / 5 mL in 1 BOTTLE 1 bottle 2014-12-15 0000-00-00 No No Current 64980-513-15 64980051315 1 BOTTLE in 1 CARTON (64980-513-15) / 15 mL in 1 BOTTLE 1 bottle 2014-12-15 0000-00-00 No No Current