Home NDC 16571-223 Timolol Maleate
Product NDC 16571-223
11-digit product format 165710223
Labeler code 16571
Product ID 16571-223_ebb620d8-8e2e-4632-b8a8-74f41c9969e6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Timolol Maleate
Dosage form TABLET
Route ORAL
Labeler Rising Pharma Holdings, Inc.
Application ANDA207556
Marketing category ANDA
Marketing start 2024-12-10
Substance TIMOLOL MALEATE
Active strength 5 mg/1
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 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A207556-001 TIMOLOL MALEATE TIMOLOL MALEATE 5MG TABLET / ORAL 2019-05-02 A207556-002 TIMOLOL MALEATE TIMOLOL MALEATE 10MG TABLET / ORAL AB 2019-05-02 A207556-003 TIMOLOL MALEATE TIMOLOL MALEATE 20MG TABLET / ORAL RS 2019-05-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A207556-002 AB
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 4 · 123 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 2026-02-19 14:30 UTC 2026-02 A207556-001 TIMOLOL MALEATE 5MG TABLET / ORAL AB 2019-05-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207556-002 TIMOLOL MALEATE 10MG TABLET / ORAL AB 2019-05-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207556-003 TIMOLOL MALEATE 20MG TABLET / ORAL AB 2019-05-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207556-001 TIMOLOL MALEATE 5MG TABLET / ORAL AB 2019-05-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207556-002 TIMOLOL MALEATE 10MG TABLET / ORAL AB 2019-05-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207556-003 TIMOLOL MALEATE 20MG TABLET / ORAL AB 2019-05-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207556-001 TIMOLOL MALEATE 5MG TABLET / ORAL AB 2019-05-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207556-002 TIMOLOL MALEATE 10MG TABLET / ORAL AB 2019-05-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207556-003 TIMOLOL MALEATE 20MG TABLET / ORAL AB 2019-05-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207556-001 TIMOLOL MALEATE 5MG TABLET / ORAL AB 2019-05-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207556-002 TIMOLOL MALEATE 10MG TABLET / ORAL AB 2019-05-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207556-003 TIMOLOL MALEATE 20MG TABLET / ORAL AB 2019-05-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207556-001 TIMOLOL MALEATE 5MG TABLET / ORAL AB 2019-05-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207556-002 TIMOLOL MALEATE 10MG TABLET / ORAL AB 2019-05-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207556-003 TIMOLOL MALEATE 20MG TABLET / ORAL AB 2019-05-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207556-001 TIMOLOL MALEATE 5MG TABLET / ORAL AB 2019-05-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207556-002 TIMOLOL MALEATE 10MG TABLET / ORAL AB 2019-05-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207556-003 TIMOLOL MALEATE 20MG TABLET / ORAL AB 2019-05-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207556-001 TIMOLOL MALEATE 5MG TABLET / ORAL AB 2019-05-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207556-002 TIMOLOL MALEATE 10MG TABLET / ORAL AB 2019-05-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207556-003 TIMOLOL MALEATE 20MG TABLET / ORAL AB 2019-05-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207556-001 TIMOLOL MALEATE 5MG TABLET / ORAL AB 2019-05-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207556-002 TIMOLOL MALEATE 10MG TABLET / ORAL AB 2019-05-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207556-003 TIMOLOL MALEATE 20MG TABLET / ORAL AB 2019-05-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207556-001 TIMOLOL MALEATE 5MG TABLET / ORAL AB 2019-05-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207556-002 TIMOLOL MALEATE 10MG TABLET / ORAL AB 2019-05-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207556-003 TIMOLOL MALEATE 20MG TABLET / ORAL AB 2019-05-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207556-001 TIMOLOL MALEATE 5MG TABLET / ORAL AB 2019-05-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207556-002 TIMOLOL MALEATE 10MG TABLET / ORAL AB 2019-05-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207556-003 TIMOLOL MALEATE 20MG TABLET / ORAL AB 2019-05-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207556-001 TIMOLOL MALEATE 5MG TABLET / ORAL AB 2019-05-02 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207556-002 TIMOLOL MALEATE 10MG TABLET / ORAL AB 2019-05-02 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207556-003 TIMOLOL MALEATE 20MG TABLET / ORAL AB 2019-05-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207556-001 TIMOLOL MALEATE 5MG TABLET / ORAL AB 2019-05-02 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207556-002 TIMOLOL MALEATE 10MG TABLET / ORAL AB 2019-05-02 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207556-003 TIMOLOL MALEATE 20MG TABLET / ORAL AB 2019-05-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207556-001 TIMOLOL MALEATE 5MG TABLET / ORAL AB 2019-05-02 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207556-002 TIMOLOL MALEATE 10MG TABLET / ORAL AB 2019-05-02 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207556-003 TIMOLOL MALEATE 20MG TABLET / ORAL AB 2019-05-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207556-001 TIMOLOL MALEATE 5MG TABLET / ORAL AB 2019-05-02 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 121 observed states.
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 5 mg/1
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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198284 Internal RxNorm lookup 198285 Internal RxNorm lookup 198286 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 16571-223-01 Timolol Maleate 100 in 1 BOTTLE TABLET 100 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16571-223 TIMOLOL MALEATE TABLET [RISING PHARMA HOLDINGS, INC.] 1 Current NDC, 1 package rows 20241212_0bc40b2c-65eb-4095-87e6-4752d5b19a3a.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 16571-223-01 16571022301 100 TABLET in 1 BOTTLE (16571-223-01) 100 tablet 2024-12-10 No No Current