Home NDC 82584-002 BETIMOL
Product NDC 82584-002
11-digit product format 825840002
Labeler code 82584
Product ID 82584-002_3891d7f3-d858-9f71-e063-6394a90af95b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name timolol
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Thea Pharma Inc.
Application NDA020439
Marketing category NDA
Marketing start 2022-11-15
Substance TIMOLOL
Active strength 5.12 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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 82584-002 82584-002-15 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N020439-001 BETIMOL TIMOLOL 0.25% SOLUTION/DROPS / OPHTHALMIC RLD 1995-03-31 N020439-002 BETIMOL TIMOLOL 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1995-03-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N020439-002 AT
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 · 82 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 N020439-001 BETIMOL 0.25% SOLUTION/DROPS / OPHTHALMIC RLD 1995-03-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020439-002 BETIMOL 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1995-03-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020439-001 BETIMOL 0.25% SOLUTION/DROPS / OPHTHALMIC RLD 1995-03-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020439-002 BETIMOL 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1995-03-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020439-001 BETIMOL 0.25% SOLUTION/DROPS / OPHTHALMIC RLD 1995-03-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020439-002 BETIMOL 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1995-03-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020439-001 BETIMOL 0.25% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1995-03-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020439-002 BETIMOL 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1995-03-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020439-001 BETIMOL 0.25% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1995-03-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020439-002 BETIMOL 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1995-03-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020439-001 BETIMOL 0.25% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1995-03-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020439-002 BETIMOL 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1995-03-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020439-001 BETIMOL 0.25% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1995-03-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020439-002 BETIMOL 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1995-03-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020439-001 BETIMOL EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 1995-03-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020439-002 BETIMOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 1995-03-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020439-001 BETIMOL 0.25% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1995-03-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020439-002 BETIMOL 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1995-03-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020439-001 BETIMOL EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 1995-03-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020439-002 BETIMOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 1995-03-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020439-001 BETIMOL EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 1995-03-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020439-002 BETIMOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 1995-03-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020439-001 BETIMOL EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 1995-03-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020439-002 BETIMOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 1995-03-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020439-001 BETIMOL EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 1995-03-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020439-002 BETIMOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 1995-03-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020439-001 BETIMOL EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 1995-03-31 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N020439-002 BETIMOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 1995-03-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020439-001 BETIMOL EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1995-03-31 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020439-002 BETIMOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1995-03-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020439-001 BETIMOL EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1995-03-31 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N020439-002 BETIMOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1995-03-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020439-001 BETIMOL EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1995-03-31 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N020439-002 BETIMOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1995-03-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020439-001 BETIMOL EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1995-03-31 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020439-002 BETIMOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1995-03-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020439-001 BETIMOL EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1995-03-31 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N020439-002 BETIMOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1995-03-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020439-001 BETIMOL EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1995-03-31 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N020439-002 BETIMOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1995-03-31 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 45 observed states.
Additional Listing Data#
Finished product Yes
Brand name base BETIMOL
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TIMOLOL 5.12 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 817W3C6175 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 208560 Internal RxNorm lookup 1992305 Internal RxNorm lookup 2702393 Internal RxNorm lookup 2702398 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 82584-002-05 BETIMOL 1 in 1 CARTON SOLUTION/ DROPS 1 6 82584-002-05 BETIMOL 5 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 5 6 82584-002-15 BETIMOL 1 in 1 CARTON SOLUTION/ DROPS 1 6 82584-002-15 BETIMOL 15 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 15 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82584-002 BETIMOL (TIMOLOL) SOLUTION/ DROPS [THEA PHARMA INC.] 5 Current NDC, Legacy NDC, 4 package rows 20240430_3ae775f4-340c-4bf4-aa49-8a31daba0f8b.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 82584-002-05 82584000205 1 BOTTLE, DROPPER in 1 CARTON (82584-002-05) / 5 mL in 1 BOTTLE, DROPPER 2022-11-15 0000-00-00 No No Current 82584-002-15 82584000215 1 BOTTLE, DROPPER in 1 CARTON (82584-002-15) > 15 mL in 1 BOTTLE, DROPPER 2022-12-01 0000-00-00 No No Current