Home NDC 24208-004 Istalol
Product NDC 24208-004
11-digit product format 242080004
Labeler code 24208
Product ID 24208-004_25b64789-6ef9-4c49-e063-6294a90a0ec4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Timolol Maleate
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Bausch & Lomb Incorporated
Application NDA021516
Marketing category NDA
Marketing start 2004-08-02
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 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 N021516-001 ISTALOL TIMOLOL MALEATE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2004-06-04
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021516-001 AT2
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 N021516-001 ISTALOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2004-06-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021516-001 ISTALOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2004-06-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021516-001 ISTALOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2004-06-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021516-001 ISTALOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2004-06-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021516-001 ISTALOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2004-06-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021516-001 ISTALOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2004-06-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021516-001 ISTALOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2004-06-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021516-001 ISTALOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2004-06-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021516-001 ISTALOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2004-06-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021516-001 ISTALOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2004-06-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021516-001 ISTALOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2004-06-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021516-001 ISTALOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2004-06-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021516-001 ISTALOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2004-06-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021516-001 ISTALOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2004-06-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021516-001 ISTALOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2004-06-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021516-001 ISTALOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2004-06-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021516-001 ISTALOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2004-06-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021516-001 ISTALOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2004-06-04 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021516-001 ISTALOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2004-06-04 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021516-001 ISTALOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2004-06-04 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021516-001 ISTALOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2004-06-04 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021516-001 ISTALOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2004-06-04 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021516-001 ISTALOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2004-06-04 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021516-001 ISTALOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2004-06-04 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021516-001 ISTALOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2004-06-04 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021516-001 ISTALOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2004-06-04 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021516-001 ISTALOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2004-06-04 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021516-001 ISTALOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2004-06-04 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021516-001 ISTALOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2004-06-04 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021516-001 ISTALOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2004-06-04 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021516-001 ISTALOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2004-06-04 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021516-001 ISTALOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2004-06-04 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021516-001 ISTALOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2004-06-04 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021516-001 ISTALOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2004-06-04 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021516-001 ISTALOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2004-06-04 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021516-001 ISTALOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2004-06-04 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021516-001 ISTALOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2004-06-04 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021516-001 ISTALOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2004-06-04 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021516-001 ISTALOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2004-06-04 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021516-001 ISTALOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2004-06-04 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 Istalol
Listing expiration 2026-12-31 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 RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1992299 Internal RxNorm lookup 1992300 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 24208-004-01 Istalol 2.5 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 2.5 22 24208-004-01 Istalol 1 in 1 CARTON SOLUTION/ DROPS 1 22 24208-004-02 Istalol 1 in 1 CARTON SOLUTION/ DROPS 1 22 24208-004-02 Istalol 2.5 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 2.5 22 24208-004-03 Istalol 1 in 1 CARTON SOLUTION/ DROPS 1 22 24208-004-03 Istalol 5 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 5 22
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 24208-004 ISTALOL (TIMOLOL MALEATE) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED] 22 Current NDC, Legacy NDC, 6 package rows 20241101_258bbc8d-00ee-45b0-ac35-6f16c4e8d45f.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 · 3 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 24208-004-01 24208000401 1 BOTTLE, DROPPER in 1 CARTON (24208-004-01) / 2.5 mL in 1 BOTTLE, DROPPER 2004-08-02 0000-00-00 No No Current 24208-004-02 24208000402 1 BOTTLE, DROPPER in 1 CARTON (24208-004-02) / 2.5 mL in 1 BOTTLE, DROPPER 2004-08-02 0000-00-00 No No Current 24208-004-03 24208000403 1 BOTTLE, DROPPER in 1 CARTON (24208-004-03) / 5 mL in 1 BOTTLE, DROPPER 2004-08-02 0000-00-00 No No Current