Betimol

Product NDC: 76478-001
11-digit product format: 764780001
Labeler code: 76478
Product ID: 76478-001_1148d491-87d2-4423-8486-4e5355e968ed
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Timolol
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Akorn
Application: NDA020439
Marketing category: NDA
Marketing start: 2014-01-02
Marketing end: 0000-00-00
Substance: TIMOLOL
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	76478-001		I	Inactivated by FDA	2026-08-11
excluded package	package	76478-001	76478-001-05	I	Inactivated by FDA	2026-08-11
excluded package	package	76478-001	76478-001-10	D	Discontinued by firm	2026-08-11
excluded package	package	76478-001	76478-001-15	D	Discontinued by firm	2026-08-11

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 · 54 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	76478-001-15	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	76478-001-10	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	76478-001-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	76478-001-15	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	76478-001-10	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	76478-001-05	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	76478-001-15	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	76478-001-10	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	76478-001-05	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	76478-001-15	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	76478-001-10	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	76478-001-05	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	76478-001-15	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	76478-001-10	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	76478-001-05	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	76478-001-15	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	76478-001-10	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	76478-001-05	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	76478-001-15	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	76478-001-10	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	76478-001-05	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	76478-001-15	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	76478-001-10	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	76478-001-05	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	76478-001-15	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	76478-001-10	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	76478-001-05	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	76478-001-15	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	76478-001-10	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	76478-001-05	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	76478-001-15	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	76478-001-10	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	76478-001-05	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	76478-001-15	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	76478-001-10	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	76478-001-05	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	76478-001-05	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	76478-001-05	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	76478-001-05	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`

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
N020439-001	BETIMOL	TIMOLOL	0.25%	SOLUTION/DROPS / OPHTHALMIC		RLD	1995-03-31
N020439-002	BETIMOL	TIMOLOL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1995-03-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N020439-002	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 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	N020439-001	BETIMOL	0.25%	SOLUTION/DROPS / OPHTHALMIC		RLD	1995-03-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020439-002	BETIMOL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1995-03-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020439-001	BETIMOL	0.25%	SOLUTION/DROPS / OPHTHALMIC		RLD	1995-03-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020439-002	BETIMOL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1995-03-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020439-001	BETIMOL	0.25%	SOLUTION/DROPS / OPHTHALMIC		RLD	1995-03-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020439-002	BETIMOL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1995-03-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020439-001	BETIMOL	0.25%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1995-03-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020439-002	BETIMOL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1995-03-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020439-001	BETIMOL	0.25%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1995-03-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020439-002	BETIMOL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1995-03-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020439-001	BETIMOL	0.25%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1995-03-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020439-002	BETIMOL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1995-03-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020439-001	BETIMOL	0.25%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1995-03-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020439-002	BETIMOL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1995-03-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020439-001	BETIMOL	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1995-03-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020439-002	BETIMOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1995-03-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020439-001	BETIMOL	0.25%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1995-03-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020439-002	BETIMOL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1995-03-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020439-001	BETIMOL	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1995-03-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020439-002	BETIMOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1995-03-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020439-001	BETIMOL	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1995-03-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020439-002	BETIMOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1995-03-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020439-001	BETIMOL	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1995-03-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020439-002	BETIMOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1995-03-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020439-001	BETIMOL	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1995-03-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020439-002	BETIMOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1995-03-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020439-001	BETIMOL	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1995-03-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020439-002	BETIMOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1995-03-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020439-001	BETIMOL	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1995-03-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020439-002	BETIMOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1995-03-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020439-001	BETIMOL	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1995-03-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020439-002	BETIMOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1995-03-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020439-001	BETIMOL	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1995-03-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020439-002	BETIMOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1995-03-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020439-001	BETIMOL	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1995-03-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020439-002	BETIMOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1995-03-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020439-001	BETIMOL	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1995-03-31	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020439-002	BETIMOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1995-03-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020439-001	BETIMOL	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1995-03-31	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020439-002	BETIMOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1995-03-31	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 45 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020439-002	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020439-002	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020439-002	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020439-002	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020439-002	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020439-002	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020439-002	AT	1	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020439-002	AT	1	`d8e5a09893c0…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020439-001	AT	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020439-002	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020439-001	AT	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020439-002	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020439-001	AT	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020439-002	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020439-001	AT	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020439-002	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020439-001	AT	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020439-002	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020439-001	AT	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020439-002	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020439-001	AT	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020439-002	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020439-001	AT	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020439-002	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020439-001	AT	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020439-002	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020439-001	AT	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020439-002	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020439-001	AT	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020439-002	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020439-001	AT	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020439-002	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020439-001	AT	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020439-002	AT	1	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	N020439-001	AT	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N020439-002	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020439-001	AT	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020439-002	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020439-001	AT	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N020439-002	AT	1	`f41ea6bd6efb…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c6c0c444-a6ba-2fb5-a7bc-7f0443fa5791	Product name	4	20251208
73103a56-9f57-4f32-a306-a42bfa2fea36	Product name	1	20250505
425025fc-f910-4afe-815b-58d4486ed4f7	Product name	4	20250331
26c5ddae-5c69-622d-e599-5fd583634968	Product name	4	20250313
ee780602-134c-4c60-a2f0-e973ba549cd4	Product name	2	20250304
03f77cb2-b4ad-3c11-8781-787b5ece4291	Product name	3	20240507
273981e4-09e7-45cc-967c-554f628ededf	Product name	3	20230627
97dad5a2-c524-a7b5-dede-82edefe9ce62	Product name	7	20220929
d11e749b-f93e-0ce3-ceda-28fe03d8081d	Product name	2	20190731

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
76478-001-05	2024-01-30	C162847	48780-1	1030e364-f9db-111a-e063-dadaa90a10e2	BETIMOL ®
76478-001-10	2024-01-30	C162847	48780-1	1030e364-f9db-111a-e063-dadaa90a10e2	BETIMOL ®
76478-001-15	2024-01-30	C162847	48780-1	1030e364-f9db-111a-e063-dadaa90a10e2	BETIMOL ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
76478-001-05	Betimol	1 in 1 CARTON	SOLUTION/ DROPS	1	5
76478-001-05	Betimol	5 mL in 1 BOTTLE	SOLUTION/ DROPS	5	5
76478-001-10	Betimol	1 in 1 CARTON	SOLUTION/ DROPS	1	5
76478-001-10	Betimol	10 mL in 1 BOTTLE	SOLUTION/ DROPS	10	5
76478-001-15	Betimol	15 mL in 1 BOTTLE	SOLUTION/ DROPS	15	5
76478-001-15	Betimol	1 in 1 CARTON	SOLUTION/ DROPS	1	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
76478-001-05	ML - Milliliter	76478-001	df0b03b8-745a-40c0-a9c3-eb9c7fc3fa39	1	2014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Timolol	ACTIVE INGREDIENT	817W3C6175	BETIMOL (TIMOLOL) SOLUTION/ DROPS [OAK PHARMACEUTICALS, INC. (SUBSIDIARY OF AKORN, INC.) (968937719)]	1
Timolol Anhydrous	ACTIVE MOIETY	5JKY92S7BR	BETIMOL (TIMOLOL) SOLUTION/ DROPS [OAK PHARMACEUTICALS, INC. (SUBSIDIARY OF AKORN, INC.) (968937719)]	1
benzalkonium chloride	INACTIVE INGREDIENT	F5UM2KM3W7	BETIMOL (TIMOLOL) SOLUTION/ DROPS [OAK PHARMACEUTICALS, INC. (SUBSIDIARY OF AKORN, INC.) (968937719)]	1
sodium phosphate, dibasic, dihydrate	INACTIVE INGREDIENT	94255I6E2T	BETIMOL (TIMOLOL) SOLUTION/ DROPS [OAK PHARMACEUTICALS, INC. (SUBSIDIARY OF AKORN, INC.) (968937719)]	1
sodium phosphate, monobasic, dihydrate	INACTIVE INGREDIENT	5QWK665956	BETIMOL (TIMOLOL) SOLUTION/ DROPS [OAK PHARMACEUTICALS, INC. (SUBSIDIARY OF AKORN, INC.) (968937719)]	1
water	INACTIVE INGREDIENT	059QF0KO0R	BETIMOL (TIMOLOL) SOLUTION/ DROPS [OAK PHARMACEUTICALS, INC. (SUBSIDIARY OF AKORN, INC.) (968937719)]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76478-001	BETIMOL (TIMOLOL) SOLUTION/ DROPS [AKORN]	5	Legacy NDC, 6 package rows	20220503_3d7acd55-33b1-4a24-99ae-01f87b0dca1f.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
BETIMOL	TIMOLOL	Thea Pharma Inc.	3ae775f4-340c-4bf4-aa49-8a31daba0f8b	2025-06-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020439 application number: NDA020439

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
817W3C6175	TIMOLOL	91524-16-2	TIMOLOL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
208560	BETIMOL 0.25 % Ophthalmic Solution	PSN	3d7acd55-33b1-4a24-99ae-01f87b0dca1f	5
1992305	BETIMOL 0.5 % Ophthalmic Solution	PSN	3d7acd55-33b1-4a24-99ae-01f87b0dca1f	5
2702398	timolol hemihydrate 0.25 % Ophthalmic Solution	PSN	3d7acd55-33b1-4a24-99ae-01f87b0dca1f	5
2702393	timolol hemihydrate 0.5 % Ophthalmic Solution	PSN	3d7acd55-33b1-4a24-99ae-01f87b0dca1f	5
208560	timolol hemihydrate 2.5 MG/ML Ophthalmic Solution [Betimol]	SBD	3d7acd55-33b1-4a24-99ae-01f87b0dca1f	5
1992305	timolol hemihydrate 5 MG/ML Ophthalmic Solution [Betimol]	SBD	3d7acd55-33b1-4a24-99ae-01f87b0dca1f	5
2702398	timolol hemihydrate 2.5 MG/ML Ophthalmic Solution	SCD	3d7acd55-33b1-4a24-99ae-01f87b0dca1f	5
2702393	timolol hemihydrate 5 MG/ML Ophthalmic Solution	SCD	3d7acd55-33b1-4a24-99ae-01f87b0dca1f	5
208560	Betimol 0.25 % Ophthalmic Solution	SY	3d7acd55-33b1-4a24-99ae-01f87b0dca1f	5
1992305	Betimol 0.5 % Ophthalmic Solution	SY	3d7acd55-33b1-4a24-99ae-01f87b0dca1f	5
208560	Betimol 2.5 MG/ML (as timolol hemihydrate 2.56 MG/ML) Ophthalmic Solution	SY	3d7acd55-33b1-4a24-99ae-01f87b0dca1f	5
208560	Betimol 2.5 MG/ML Ophthalmic Solution	SY	3d7acd55-33b1-4a24-99ae-01f87b0dca1f	5
1992305	Betimol 5 MG/ML (as timolol hemihydrate 5.12 MG/ML) Ophthalmic Solution	SY	3d7acd55-33b1-4a24-99ae-01f87b0dca1f	5
2702398	timolol 2.5 MG/ML (as timolol hemihydrate 2.56 MG/ML) Ophthalmic Solution	SY	3d7acd55-33b1-4a24-99ae-01f87b0dca1f	5
2702393	timolol 5 MG/ML (as timolol hemihydrate 5.12 MG/ML) Ophthalmic Solution	SY	3d7acd55-33b1-4a24-99ae-01f87b0dca1f	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
76478-001-05	76478000105	1 BOTTLE in 1 CARTON (76478-001-05) > 5 mL in 1 BOTTLE	1 bottle	2014-01-02	0000-00-00	No	No	Current
76478-001-10	76478000110	1 BOTTLE in 1 CARTON (76478-001-10) > 10 mL in 1 BOTTLE	1 bottle	2014-01-02	0000-00-00	No	No	Current
76478-001-15	76478000115	1 BOTTLE in 1 CARTON (76478-001-15) > 15 mL in 1 BOTTLE	1 bottle	2014-01-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BETIMOL ®	Akorn \| Akorn Operating Company LLC \| Akorn AG	2020-10-08	HUMAN PRESCRIPTION DRUG LABEL	5