Home NDC 0065-0246-15 Betoptic S
Product NDC 0065-0246
Requested package NDC 0065-0246-15
11-digit product format 000650246
Labeler code 0065
Product ID 0065-0246_afa45084-f5fa-44f2-ac80-bad92bb5208e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name betaxolol hydrochloride
Dosage form SUSPENSION/ DROPS
Route OPHTHALMIC
Labeler Alcon Laboratories, Inc.
Application NDA019845
Marketing category NDA
Marketing start 1996-01-15
Marketing end 0000-00-00
Substance BETAXOLOL HYDROCHLORIDE
Active strength 3 mg/mL
Pharmacologic classes Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
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 · 11 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…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N019845-001 BETOPTIC S BETAXOLOL HYDROCHLORIDE EQ 0.25% BASE SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1989-12-29
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 · 41 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 N019845-001 BETOPTIC S EQ 0.25% BASE SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1989-12-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019845-001 BETOPTIC S EQ 0.25% BASE SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1989-12-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019845-001 BETOPTIC S EQ 0.25% BASE SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1989-12-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019845-001 BETOPTIC S EQ 0.25% BASE SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1989-12-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019845-001 BETOPTIC S EQ 0.25% BASE SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1989-12-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019845-001 BETOPTIC S EQ 0.25% BASE SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1989-12-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019845-001 BETOPTIC S EQ 0.25% BASE SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1989-12-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019845-001 BETOPTIC S EQ 0.25% BASE SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1989-12-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019845-001 BETOPTIC S EQ 0.25% BASE SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1989-12-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019845-001 BETOPTIC S EQ 0.25% BASE SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1989-12-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019845-001 BETOPTIC S EQ 0.25% BASE SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1989-12-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019845-001 BETOPTIC S EQ 0.25% BASE SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1989-12-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019845-001 BETOPTIC S EQ 0.25% BASE SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1989-12-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N019845-001 BETOPTIC S EQ 0.25% BASE SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1989-12-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019845-001 BETOPTIC S EQ 0.25% BASE SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1989-12-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N019845-001 BETOPTIC S EQ 0.25% BASE SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1989-12-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N019845-001 BETOPTIC S EQ 0.25% BASE SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1989-12-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N019845-001 BETOPTIC S EQ 0.25% BASE SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1989-12-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N019845-001 BETOPTIC S EQ 0.25% BASE SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1989-12-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N019845-001 BETOPTIC S EQ 0.25% BASE SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1989-12-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N019845-001 BETOPTIC S EQ 0.25% BASE SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1989-12-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N019845-001 BETOPTIC S EQ 0.25% BASE SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1989-12-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N019845-001 BETOPTIC S EQ 0.25% BASE SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1989-12-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N019845-001 BETOPTIC S EQ 0.25% BASE SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1989-12-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N019845-001 BETOPTIC S EQ 0.25% BASE SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1989-12-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N019845-001 BETOPTIC S EQ 0.25% BASE SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1989-12-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N019845-001 BETOPTIC S EQ 0.25% BASE SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1989-12-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N019845-001 BETOPTIC S EQ 0.25% BASE SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1989-12-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N019845-001 BETOPTIC S EQ 0.25% BASE SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1989-12-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N019845-001 BETOPTIC S EQ 0.25% BASE SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1989-12-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N019845-001 BETOPTIC S EQ 0.25% BASE SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1989-12-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N019845-001 BETOPTIC S EQ 0.25% BASE SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1989-12-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N019845-001 BETOPTIC S EQ 0.25% BASE SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1989-12-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N019845-001 BETOPTIC S EQ 0.25% BASE SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1989-12-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N019845-001 BETOPTIC S EQ 0.25% BASE SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1989-12-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N019845-001 BETOPTIC S EQ 0.25% BASE SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1989-12-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N019845-001 BETOPTIC S EQ 0.25% BASE SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1989-12-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N019845-001 BETOPTIC S EQ 0.25% BASE SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1989-12-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N019845-001 BETOPTIC S EQ 0.25% BASE SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1989-12-29 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N019845-001 BETOPTIC S EQ 0.25% BASE SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1989-12-29 cb3db0bc1861…
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Betaxolol Hydrochloride ACTIVE INGREDIENT 6X97D2XT0O BETOPTIC S (BETAXOLOL HYDROCHLORIDE) SUSPENSION [ALCON LABORATORIES, INC.] 3 Betaxolol ACTIVE MOIETY O0ZR1R6RZ2 BETOPTIC S (BETAXOLOL HYDROCHLORIDE) SUSPENSION [ALCON LABORATORIES, INC.] 3 Benzalkonium Chloride INACTIVE INGREDIENT F5UM2KM3W7 BETOPTIC S (BETAXOLOL HYDROCHLORIDE) SUSPENSION [ALCON LABORATORIES, INC.] 3 Edetate Disodium INACTIVE INGREDIENT 7FLD91C86K BETOPTIC S (BETAXOLOL HYDROCHLORIDE) SUSPENSION [ALCON LABORATORIES, INC.] 3 Hydrochloric Acid INACTIVE INGREDIENT QTT17582CB BETOPTIC S (BETAXOLOL HYDROCHLORIDE) SUSPENSION [ALCON LABORATORIES, INC.] 3 Mannitol INACTIVE INGREDIENT 3OWL53L36A BETOPTIC S (BETAXOLOL HYDROCHLORIDE) SUSPENSION [ALCON LABORATORIES, INC.] 3 Sodium Hydroxide INACTIVE INGREDIENT 55X04QC32I BETOPTIC S (BETAXOLOL HYDROCHLORIDE) SUSPENSION [ALCON LABORATORIES, INC.] 3 Water INACTIVE INGREDIENT 059QF0KO0R BETOPTIC S (BETAXOLOL HYDROCHLORIDE) SUSPENSION [ALCON LABORATORIES, INC.] 3
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Betoptic S BETAXOLOL HYDROCHLORIDE Novartis Pharmaceuticals Corporation 905ba189-456c-4aa4-8231-39a971374ad8 2025-01-22 Warnings, Adverse reactions Exact identifier application applno (NDA): 019845 application number: NDA019845
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0065-0246-15 00065024615 1 BOTTLE, PLASTIC in 1 CARTON (0065-0246-15) > 15 mL in 1 BOTTLE, PLASTIC 1996-01-15 0000-00-00 No No Current