Home NDC 60429-753-01 Betaxolol
Product NDC 60429-753
Requested package NDC 60429-753-01
11-digit product format 604290753
Labeler code 60429
Product ID 60429-753_e5fe2932-8e49-dd4e-e053-2a95a90a0c32
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Betaxolol
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Golden State Medical Supply, Inc.
Application ANDA078962
Marketing category ANDA
Marketing start 2008-06-27
Marketing end 2022-09-30
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 0000-00-00
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded 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
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 60429-753-01 60429075301 100 TABLET, FILM COATED in 1 BOTTLE (60429-753-01) 2012-06-01 2022-09-30 No No Current