Home NDC 61314-245 Betaxolol Hydrochloride
Product NDC 61314-245
11-digit product format 613140245
Labeler code 61314
Product ID 61314-245_c30e555b-1a79-4c3e-b79d-8c1d950fd832
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Betaxolol Hydrochloride
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Sandoz Inc
Application NDA019270
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2000-05-15
Substance BETAXOLOL HYDROCHLORIDE
Active strength 5.6 mg/mL
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N019270-001 BETOPTIC BETAXOLOL HYDROCHLORIDE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-08-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N019270-001 AT
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 N019270-001 BETOPTIC EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-08-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019270-001 BETOPTIC EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-08-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019270-001 BETOPTIC EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-08-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019270-001 BETOPTIC EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-08-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019270-001 BETOPTIC EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-08-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019270-001 BETOPTIC EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-08-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019270-001 BETOPTIC EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-08-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019270-001 BETOPTIC EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-08-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019270-001 BETOPTIC EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-08-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019270-001 BETOPTIC EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-08-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019270-001 BETOPTIC EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-08-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019270-001 BETOPTIC EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-08-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019270-001 BETOPTIC EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-08-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N019270-001 BETOPTIC EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-08-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019270-001 BETOPTIC EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-08-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N019270-001 BETOPTIC EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-08-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N019270-001 BETOPTIC EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-08-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N019270-001 BETOPTIC EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-08-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N019270-001 BETOPTIC EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-08-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N019270-001 BETOPTIC EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-08-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N019270-001 BETOPTIC EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-08-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N019270-001 BETOPTIC EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-08-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N019270-001 BETOPTIC EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-08-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N019270-001 BETOPTIC EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-08-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N019270-001 BETOPTIC EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-08-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N019270-001 BETOPTIC EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-08-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N019270-001 BETOPTIC EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-08-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N019270-001 BETOPTIC EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-08-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N019270-001 BETOPTIC EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-08-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N019270-001 BETOPTIC EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-08-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N019270-001 BETOPTIC EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-08-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N019270-001 BETOPTIC EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-08-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N019270-001 BETOPTIC EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-08-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N019270-001 BETOPTIC EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-08-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N019270-001 BETOPTIC EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-08-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N019270-001 BETOPTIC EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-08-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N019270-001 BETOPTIC EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-08-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N019270-001 BETOPTIC EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-08-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N019270-001 BETOPTIC EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-08-30 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N019270-001 BETOPTIC EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-08-30 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 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 5.6 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 308720 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 61314-245-01 Betaxolol Hydrochloride 5 mL in 1 BOTTLE, PLASTIC SOLUTION/ DROPS 5 9 61314-245-01 Betaxolol Hydrochloride 1 in 1 CARTON SOLUTION/ DROPS 1 9 61314-245-02 Betaxolol Hydrochloride 15 mL in 1 BOTTLE, PLASTIC SOLUTION/ DROPS 15 9 61314-245-02 Betaxolol Hydrochloride 1 in 1 CARTON SOLUTION/ DROPS 1 9 61314-245-03 Betaxolol Hydrochloride 10 mL in 1 BOTTLE, PLASTIC SOLUTION/ DROPS 10 9 61314-245-03 Betaxolol Hydrochloride 1 in 1 CARTON SOLUTION/ DROPS 1 9
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61314-245 BETAXOLOL HYDROCHLORIDE SOLUTION/ DROPS [SANDOZ INC] 9 Current NDC, Legacy NDC, 6 package rows 20231121_a73519d5-546c-4377-92ed-0d4be2685d60.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 61314-245-01 61314024501 1 BOTTLE, PLASTIC in 1 CARTON (61314-245-01) / 5 mL in 1 BOTTLE, PLASTIC 2000-05-15 0000-00-00 No No Current 61314-245-02 61314024502 1 BOTTLE, PLASTIC in 1 CARTON (61314-245-02) / 15 mL in 1 BOTTLE, PLASTIC 2000-05-15 0000-00-00 No No Current 61314-245-03 61314024503 1 BOTTLE, PLASTIC in 1 CARTON (61314-245-03) / 10 mL in 1 BOTTLE, PLASTIC 2000-05-15 0000-00-00 No No Current