Home NDC 24658-701 Betaxolol
Product NDC 24658-701
11-digit product format 246580701
Labeler code 24658
Product ID 24658-701_7ee988e7-153d-4d55-b4ec-1a8da8f78f1d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Betaxolol
Dosage form TABLET, FILM COATED
Route ORAL
Labeler PuraCap Laboratories LLC
Application ANDA075541
Marketing category ANDA
Marketing start 2016-08-22
Substance BETAXOLOL HYDROCHLORIDE
Active strength 20 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A075541-001 BETAXOLOL HYDROCHLORIDE BETAXOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1999-10-22 A075541-002 BETAXOLOL HYDROCHLORIDE BETAXOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB RS 1999-10-22
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 · 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 A075541-001 BETAXOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1999-10-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075541-002 BETAXOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB RS 1999-10-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075541-001 BETAXOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1999-10-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075541-002 BETAXOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB RS 1999-10-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075541-001 BETAXOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1999-10-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075541-002 BETAXOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB RS 1999-10-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075541-001 BETAXOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1999-10-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075541-002 BETAXOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB RS 1999-10-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075541-001 BETAXOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1999-10-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075541-002 BETAXOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB RS 1999-10-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075541-001 BETAXOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1999-10-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075541-002 BETAXOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB RS 1999-10-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075541-001 BETAXOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1999-10-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075541-002 BETAXOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB RS 1999-10-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075541-001 BETAXOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1999-10-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075541-002 BETAXOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB RS 1999-10-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075541-001 BETAXOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1999-10-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075541-002 BETAXOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB RS 1999-10-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075541-001 BETAXOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1999-10-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075541-002 BETAXOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB RS 1999-10-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075541-001 BETAXOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1999-10-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075541-002 BETAXOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB RS 1999-10-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075541-001 BETAXOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1999-10-22 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075541-002 BETAXOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB RS 1999-10-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075541-001 BETAXOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1999-10-22 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075541-002 BETAXOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB RS 1999-10-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075541-001 BETAXOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1999-10-22 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A075541-002 BETAXOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB RS 1999-10-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075541-001 BETAXOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1999-10-22 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075541-002 BETAXOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB RS 1999-10-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075541-001 BETAXOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1999-10-22 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A075541-002 BETAXOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB RS 1999-10-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075541-001 BETAXOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1999-10-22 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A075541-002 BETAXOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB RS 1999-10-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075541-001 BETAXOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1999-10-22 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A075541-002 BETAXOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB RS 1999-10-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075541-001 BETAXOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1999-10-22 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A075541-002 BETAXOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB RS 1999-10-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075541-001 BETAXOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1999-10-22 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A075541-002 BETAXOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB RS 1999-10-22 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Betaxolol
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BETAXOLOL HYDROCHLORIDE 20 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 6X97D2XT0O Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1297753 Internal RxNorm lookup 1297757 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 24658-701-01 Betaxolol 100 in 1 BOTTLE TABLET, FILM COATED 100 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 24658-701 BETAXOLOL TABLET, FILM COATED [PURACAP LABORATORIES LLC] 4 Current NDC, Legacy NDC, 1 package rows 20191101_e198244d-fda3-4015-8c01-390f3f88e238.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 Marketing start Marketing end Sample Exclude flag Status 24658-701-01 24658070101 100 TABLET, FILM COATED in 1 BOTTLE (24658-701-01) 2016-12-15 0000-00-00 No No Current