Home NDC 10702-014 BETAXOLOL HYDROCHLORIDE
Product NDC 10702-014
11-digit product format 107020014
Labeler code 10702
Product ID 10702-014_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 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 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.
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 2026-08-01 22:54:32 2026-06 A078962-001 BETAXOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 2008-06-27 a50c72e98297…2026-08-01 22:54:32 2026-06 A078962-002 BETAXOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB 2008-06-27 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A078962-001 AB 1 a50c72e98297…2026-08-01 22:54:32 2026-06 A078962-002 AB 1 a50c72e98297…
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 · 1 matching rows.
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 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.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 10702-014-01 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 10702-014 BETAXOLOL HYDROCHLORIDE TABLET, COATED [KVK-TECH, INC.] 10 Current NDC, Legacy NDC, 1 package rows 20240502_f3b50bbb-df03-4ed7-9d8d-180edc2abd54.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 10702-014-01 10702001401 100 TABLET, COATED in 1 BOTTLE (10702-014-01) 2011-11-02 0000-00-00 No No Current