Home NDC 0078-0729 Betoptic S
Product NDC 0078-0729
11-digit product format 000780729
Labeler code 0078
Product ID 0078-0729_c0cc485e-81d4-4204-a894-caa615bea90b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name betaxolol hydrochloride
Dosage form SUSPENSION/ DROPS
Route OPHTHALMIC
Labeler Novartis Pharmaceuticals Corporation
Application NDA019845
Marketing category NDA
Marketing start 1996-01-15
Marketing end 2026-11-30
Substance BETAXOLOL HYDROCHLORIDE
Active strength 2.8 mg/mL
Pharmacologic classes Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag No
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 · 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…
Additional Listing Data#
Finished product Yes
Brand name base Betoptic S Active Ingredients# Ingredient, Strength table Ingredient Strength BETAXOLOL HYDROCHLORIDE 2.8 mg/mL
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 213729 Internal RxNorm lookup 308719 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 0078-0729-10 Betoptic S 1 in 1 CARTON SUSPENSION/ DROPS 1 4 0078-0729-10 Betoptic S 10 mL in 1 BOTTLE SUSPENSION/ DROPS 10 4 0078-0729-15 Betoptic S 15 mL in 1 BOTTLE SUSPENSION/ DROPS 15 4 0078-0729-15 Betoptic S 1 in 1 CARTON SUSPENSION/ DROPS 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0078-0729 BETOPTIC S (BETAXOLOL HYDROCHLORIDE) SUSPENSION/ DROPS [NOVARTIS PHARMACEUTICALS CORPORATION] 4 Current NDC, Legacy NDC, 4 package rows 20250123_905ba189-456c-4aa4-8231-39a971374ad8.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.
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 ndc (product): 0078-0729
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0078-0729-10 00078072910 1 BOTTLE in 1 CARTON (0078-0729-10) / 10 mL in 1 BOTTLE 1 bottle 2022-08-03 2026-11-30 No No Current 0078-0729-15 00078072915 1 BOTTLE in 1 CARTON (0078-0729-15) / 15 mL in 1 BOTTLE 1 bottle 2022-08-03 2026-11-30 No No Current