Home NDC 76478-002-12 Betimol
Product NDC 76478-002
Requested package NDC 76478-002-12
11-digit product format 764780002
Labeler code 76478
Product ID 76478-002_1148d491-87d2-4423-8486-4e5355e968ed
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Timolol
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Akorn
Application NDA020439
Marketing category NDA
Marketing start 2014-01-02
Marketing end 0000-00-00
Substance TIMOLOL
Active strength 5 mg/mL
Pharmacologic classes Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record 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 · 15 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
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.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Timolol ACTIVE INGREDIENT 817W3C6175 BETIMOL (TIMOLOL) SOLUTION/ DROPS [OAK PHARMACEUTICALS, INC. (SUBSIDIARY OF AKORN, INC.) (968937719)] 1 Timolol Anhydrous ACTIVE MOIETY 5JKY92S7BR BETIMOL (TIMOLOL) SOLUTION/ DROPS [OAK PHARMACEUTICALS, INC. (SUBSIDIARY OF AKORN, INC.) (968937719)] 1 benzalkonium chloride INACTIVE INGREDIENT F5UM2KM3W7 BETIMOL (TIMOLOL) SOLUTION/ DROPS [OAK PHARMACEUTICALS, INC. (SUBSIDIARY OF AKORN, INC.) (968937719)] 1 sodium phosphate, dibasic, dihydrate INACTIVE INGREDIENT 94255I6E2T BETIMOL (TIMOLOL) SOLUTION/ DROPS [OAK PHARMACEUTICALS, INC. (SUBSIDIARY OF AKORN, INC.) (968937719)] 1 sodium phosphate, monobasic, dihydrate INACTIVE INGREDIENT 5QWK665956 BETIMOL (TIMOLOL) SOLUTION/ DROPS [OAK PHARMACEUTICALS, INC. (SUBSIDIARY OF AKORN, INC.) (968937719)] 1 water INACTIVE INGREDIENT 059QF0KO0R BETIMOL (TIMOLOL) SOLUTION/ DROPS [OAK PHARMACEUTICALS, INC. (SUBSIDIARY OF AKORN, INC.) (968937719)] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76478-002 BETIMOL (TIMOLOL) SOLUTION/ DROPS [AKORN] 5 Legacy NDC, 8 package rows 20220503_3d7acd55-33b1-4a24-99ae-01f87b0dca1f.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 Marketing end Sample Exclude flag Status 76478-002-12 76478000212 1 BOTTLE in 1 CARTON (76478-002-12) > 2.5 mL in 1 BOTTLE 1 bottle 2014-01-02 0000-00-00 Yes No Current