Home NDC 42806-039 Betaxolol
Product NDC 42806-039
11-digit product format 428060039
Labeler code 42806
Product ID 42806-039_666cb1d9-ec1f-453a-be4f-fafa2b67c1fd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Betaxolol
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Epic Pharma LLC
Application ANDA075541
Marketing category ANDA
Marketing start 2010-07-20
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 42806-039-01 Betaxolol 100 in 1 BOTTLE TABLET, FILM COATED 100 12 42806-039-10 Betaxolol 1000 in 1 BOTTLE TABLET, FILM COATED 1000 12
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded BETAXOLOL HYDROCHLORIDE ACTIVE INGREDIENT 6X97D2XT0O BETAXOLOL TABLET, FILM COATED [EPIC PHARMA LLC] 7 BETAXOLOL ACTIVE MOIETY O0ZR1R6RZ2 BETAXOLOL TABLET, FILM COATED [EPIC PHARMA LLC] 7 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK BETAXOLOL TABLET, FILM COATED [EPIC PHARMA LLC] 7 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ BETAXOLOL TABLET, FILM COATED [EPIC PHARMA LLC] 7 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U BETAXOLOL TABLET, FILM COATED [EPIC PHARMA LLC] 7 HYPROMELLOSE 2208 (100 MPA.S) INACTIVE INGREDIENT B1QE5P712K BETAXOLOL TABLET, FILM COATED [EPIC PHARMA LLC] 7 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A BETAXOLOL TABLET, FILM COATED [EPIC PHARMA LLC] 7 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H BETAXOLOL TABLET, FILM COATED [EPIC PHARMA LLC] 7 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 BETAXOLOL TABLET, FILM COATED [EPIC PHARMA LLC] 7 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ BETAXOLOL TABLET, FILM COATED [EPIC PHARMA LLC] 7 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP BETAXOLOL TABLET, FILM COATED [EPIC PHARMA LLC] 7 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP BETAXOLOL TABLET, FILM COATED [EPIC PHARMA LLC] 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42806-039 BETAXOLOL TABLET, FILM COATED [EPIC PHARMA LLC] 12 Current NDC, Legacy NDC, 2 package rows 20241222_bf716efe-0a9f-43b1-9d8a-c69330b82e18.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 42806-039-01 42806003901 100 TABLET, FILM COATED in 1 BOTTLE (42806-039-01) 2010-07-20 0000-00-00 No No Current 42806-039-10 42806003910 1000 TABLET, FILM COATED in 1 BOTTLE (42806-039-10) 2010-07-20 0000-00-00 No No Current