Home NDC 42806-038 Betaxolol
Product NDC 42806-038
11-digit product format 428060038
Labeler code 42806
Product ID 42806-038_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 10 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 2 · 72 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 2025-01-19 17:59 UTC 2025-01 A075541-001 BETAXOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1999-10-22 03ed91905a0d…2025-01-19 17:59 UTC 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…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075541-001 BETAXOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1999-10-22 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075541-002 BETAXOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB RS 1999-10-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075541-001 BETAXOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1999-10-22 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 A075541-002 BETAXOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB RS 1999-10-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075541-001 BETAXOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1999-10-22 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 A075541-002 BETAXOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB RS 1999-10-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075541-001 BETAXOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1999-10-22 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 A075541-002 BETAXOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB RS 1999-10-22 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075541-001 BETAXOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1999-10-22 3f01610625f2…2019-12-14 00:12 UTC 2019-12 A075541-002 BETAXOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB RS 1999-10-22 3f01610625f2…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 72 observed states.
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Betaxolol
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BETAXOLOL HYDROCHLORIDE 10 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 42806-038-01 Betaxolol 100 in 1 BOTTLE TABLET, FILM COATED 100 12 42806-038-10 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 BETAXOLOL HYDROCHLORIDE ACTIVE INGREDIENT 6X97D2XT0O BETAXOLOL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 BETAXOLOL ACTIVE MOIETY O0ZR1R6RZ2 BETAXOLOL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK BETAXOLOL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ BETAXOLOL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U BETAXOLOL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO BETAXOLOL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A BETAXOLOL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H BETAXOLOL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 BETAXOLOL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ BETAXOLOL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP BETAXOLOL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP BETAXOLOL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42806-038 BETAXOLOL TABLET, FILM COATED [EPIC PHARMA LLC] 12 Current NDC, Legacy NDC, 2 package rows 20241222_bf716efe-0a9f-43b1-9d8a-c69330b82e18.zip
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 42806-038-01 42806003801 100 TABLET, FILM COATED in 1 BOTTLE (42806-038-01) 2010-07-20 0000-00-00 No No Current 42806-038-10 42806003810 1000 TABLET, FILM COATED in 1 BOTTLE (42806-038-10) 2010-07-20 0000-00-00 No No Current