Home NDC 10702-013 BETAXOLOL HYDROCHLORIDE
Product NDC 10702-013
11-digit product format 107020013
Labeler code 10702
Product ID 10702-013_1757ca78-c783-c977-e063-6294a90a7862
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name betaxolol hydrochloride
Dosage form TABLET, COATED
Route ORAL
Labeler KVK-TECH, INC.
Application ANDA078962
Marketing category ANDA
Marketing start 2011-11-02
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 A078962-001 BETAXOLOL HYDROCHLORIDE BETAXOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 2008-06-27 A078962-002 BETAXOLOL HYDROCHLORIDE BETAXOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB 2008-06-27
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 A078962-001 BETAXOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 2008-06-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078962-002 BETAXOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB 2008-06-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078962-001 BETAXOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 2008-06-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078962-002 BETAXOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB 2008-06-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078962-001 BETAXOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 2008-06-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078962-002 BETAXOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB 2008-06-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078962-001 BETAXOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 2008-06-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078962-002 BETAXOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB 2008-06-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078962-001 BETAXOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 2008-06-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078962-002 BETAXOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB 2008-06-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078962-001 BETAXOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 2008-06-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078962-002 BETAXOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB 2008-06-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078962-001 BETAXOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 2008-06-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078962-002 BETAXOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB 2008-06-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078962-001 BETAXOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 2008-06-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078962-002 BETAXOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB 2008-06-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078962-001 BETAXOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 2008-06-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078962-002 BETAXOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB 2008-06-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078962-001 BETAXOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 2008-06-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078962-002 BETAXOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB 2008-06-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078962-001 BETAXOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 2008-06-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078962-002 BETAXOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB 2008-06-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078962-001 BETAXOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 2008-06-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078962-002 BETAXOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB 2008-06-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078962-001 BETAXOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 2008-06-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078962-002 BETAXOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB 2008-06-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078962-001 BETAXOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 2008-06-27 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A078962-002 BETAXOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB 2008-06-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078962-001 BETAXOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 2008-06-27 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078962-002 BETAXOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB 2008-06-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078962-001 BETAXOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 2008-06-27 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A078962-002 BETAXOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB 2008-06-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078962-001 BETAXOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 2008-06-27 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A078962-002 BETAXOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB 2008-06-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078962-001 BETAXOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 2008-06-27 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A078962-002 BETAXOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB 2008-06-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078962-001 BETAXOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 2008-06-27 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A078962-002 BETAXOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB 2008-06-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078962-001 BETAXOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 2008-06-27 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A078962-002 BETAXOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB 2008-06-27 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 HYDROCHLORIDE
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.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 10702-013-01 BETAXOLOL HYDROCHLORIDE 100 in 1 BOTTLE TABLET, COATED 100 10
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded BETAXOLOL HYDROCHLORIDE ACTIVE INGREDIENT 6X97D2XT0O BETAXOLOL HYDROCHLORIDE TABLET, COATED [KVK-TECH, INC.] 4 BETAXOLOL ACTIVE MOIETY O0ZR1R6RZ2 BETAXOLOL HYDROCHLORIDE TABLET, COATED [KVK-TECH, INC.] 4 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK BETAXOLOL HYDROCHLORIDE TABLET, COATED [KVK-TECH, INC.] 4 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ BETAXOLOL HYDROCHLORIDE TABLET, COATED [KVK-TECH, INC.] 4 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U BETAXOLOL HYDROCHLORIDE TABLET, COATED [KVK-TECH, INC.] 4 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 BETAXOLOL HYDROCHLORIDE TABLET, COATED [KVK-TECH, INC.] 4 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ BETAXOLOL HYDROCHLORIDE TABLET, COATED [KVK-TECH, INC.] 4 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H BETAXOLOL HYDROCHLORIDE TABLET, COATED [KVK-TECH, INC.] 4 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 BETAXOLOL HYDROCHLORIDE TABLET, COATED [KVK-TECH, INC.] 4 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ BETAXOLOL HYDROCHLORIDE TABLET, COATED [KVK-TECH, INC.] 4 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP BETAXOLOL HYDROCHLORIDE TABLET, COATED [KVK-TECH, INC.] 4 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP BETAXOLOL HYDROCHLORIDE TABLET, COATED [KVK-TECH, INC.] 4 BETAXOLOL HYDROCHLORIDE ACTIVE INGREDIENT 6X97D2XT0O BETAXOLOL TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 BETAXOLOL ACTIVE MOIETY O0ZR1R6RZ2 BETAXOLOL TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK BETAXOLOL TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ BETAXOLOL TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U BETAXOLOL TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO BETAXOLOL TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 POLYETHYLENE GLYCOL INACTIVE INGREDIENT 3WJQ0SDW1A BETAXOLOL TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H BETAXOLOL TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 BETAXOLOL TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ BETAXOLOL TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP BETAXOLOL TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP BETAXOLOL TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10702-013 BETAXOLOL HYDROCHLORIDE TABLET, COATED [KVK-TECH, INC.] 10 Current NDC, Legacy NDC, 1 package rows 20240502_f3b50bbb-df03-4ed7-9d8d-180edc2abd54.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 10702-013-01 10702001301 100 TABLET, COATED in 1 BOTTLE (10702-013-01) 2011-11-02 0000-00-00 No No Current