Betoptic S

Product NDC: 0065-0246
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0065-0246		D	Discontinued by firm	2026-08-10
excluded package	package	0065-0246	0065-0246-10	D	Discontinued by firm	2026-08-10
excluded package	package	0065-0246	0065-0246-15	D	Discontinued by firm	2026-08-10

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 · 34 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0065-0246-15	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0065-0246-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0065-0246-15	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0065-0246-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0065-0246-15	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0065-0246-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0065-0246-15	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0065-0246-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0065-0246-15	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0065-0246-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0065-0246-15	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0065-0246-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0065-0246-15	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0065-0246-10	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0065-0246-15	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0065-0246-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0065-0246-15	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0065-0246-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0065-0246-15	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0065-0246-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0065-0246-15	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0065-0246-10	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0065-0246-10	`557ba5c1ecfa…`	`9c80585c8c6e…`

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	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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0065-0246-10	ML - Milliliter	0065-0246	21ee4384-6903-4031-bcff-64853027f001	1	2012-07-24
0065-0246-15	ML - Milliliter	0065-0246	440f31e6-6cb4-499a-8866-0f4be8823dd1	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6X97D2XT0O	BETAXOLOL HYDROCHLORIDE	63659-19-8	BETAXOLOL HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0065-0246-10	00065024610	1 BOTTLE, PLASTIC in 1 CARTON (0065-0246-10) > 10 mL in 1 BOTTLE, PLASTIC	1996-01-15	0000-00-00	No	No	Current
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