Levobunolol Hydrochloride

Product NDC: 24208-505
11-digit product format: 242080505
Labeler code: 24208
Product ID: 24208-505_1e033456-2f30-9208-e063-6394a90a094f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Levobunolol Hydrochloride
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Bausch & Lomb Incorporated
Application: ANDA074326
Marketing category: ANDA
Marketing start: 1994-03-04
Substance: LEVOBUNOLOL HYDROCHLORIDE
Active strength: 5 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
A074326-001	LEVOBUNOLOL HYDROCHLORIDE	LEVOBUNOLOL HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT		1994-03-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074326-001	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A074326-001	LEVOBUNOLOL HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	1994-03-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074326-001	LEVOBUNOLOL HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	1994-03-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074326-001	LEVOBUNOLOL HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	1994-03-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074326-001	LEVOBUNOLOL HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	1994-03-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074326-001	LEVOBUNOLOL HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	1994-03-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074326-001	LEVOBUNOLOL HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	1994-03-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074326-001	LEVOBUNOLOL HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	1994-03-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074326-001	LEVOBUNOLOL HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	1994-03-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074326-001	LEVOBUNOLOL HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	1994-03-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074326-001	LEVOBUNOLOL HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	1994-03-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074326-001	LEVOBUNOLOL HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	1994-03-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074326-001	LEVOBUNOLOL HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	1994-03-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074326-001	LEVOBUNOLOL HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	1994-03-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074326-001	LEVOBUNOLOL HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	1994-03-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074326-001	LEVOBUNOLOL HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	1994-03-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074326-001	LEVOBUNOLOL HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	1994-03-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074326-001	LEVOBUNOLOL HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	1994-03-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074326-001	LEVOBUNOLOL HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	1994-03-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074326-001	LEVOBUNOLOL HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	1994-03-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074326-001	LEVOBUNOLOL HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	1994-03-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074326-001	LEVOBUNOLOL HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	1994-03-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074326-001	LEVOBUNOLOL HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	1994-03-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074326-001	LEVOBUNOLOL HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	1994-03-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074326-001	LEVOBUNOLOL HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	1994-03-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074326-001	LEVOBUNOLOL HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	1994-03-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074326-001	LEVOBUNOLOL HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	1994-03-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074326-001	LEVOBUNOLOL HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	1994-03-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074326-001	LEVOBUNOLOL HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	1994-03-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074326-001	LEVOBUNOLOL HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	1994-03-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074326-001	LEVOBUNOLOL HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	1994-03-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074326-001	LEVOBUNOLOL HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	1994-03-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074326-001	LEVOBUNOLOL HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	1994-03-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074326-001	LEVOBUNOLOL HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	1994-03-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074326-001	LEVOBUNOLOL HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	1994-03-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074326-001	LEVOBUNOLOL HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	1994-03-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074326-001	LEVOBUNOLOL HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	1994-03-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074326-001	LEVOBUNOLOL HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	1994-03-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074326-001	LEVOBUNOLOL HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	1994-03-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074326-001	LEVOBUNOLOL HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	1994-03-04	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A074326-001	LEVOBUNOLOL HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	1994-03-04	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A074326-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074326-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074326-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074326-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074326-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074326-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074326-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074326-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074326-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074326-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074326-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074326-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074326-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074326-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074326-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074326-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074326-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074326-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074326-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074326-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074326-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074326-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074326-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074326-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074326-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074326-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074326-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074326-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074326-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074326-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074326-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074326-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074326-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074326-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074326-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074326-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074326-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074326-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074326-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A074326-001	AT	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Levobunolol Hydrochloride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LEVOBUNOLOL HYDROCHLORIDE	5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
O90S49LDHH	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1150836	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5ab1efbe-530b-4787-b40a-c7dbf18161e1	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
efd58dcf-540a-4531-8766-e713129ca6f2	Product name	1	20250307
4b7700e3-6e0e-45e5-9d22-6f754d61386e	Product name	2	20250304
803345b7-00e4-b8c2-81f6-8628d34cb6ae	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
24208-505-05	Levobunolol Hydrochloride	5 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	5	13
24208-505-05	Levobunolol Hydrochloride	1 in 1 CARTON	SOLUTION/ DROPS	1	13
24208-505-10	Levobunolol Hydrochloride	1 in 1 CARTON	SOLUTION/ DROPS	1	13
24208-505-10	Levobunolol Hydrochloride	10 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	10	13
24208-505-15	Levobunolol Hydrochloride	15 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	15	13
24208-505-15	Levobunolol Hydrochloride	1 in 1 CARTON	SOLUTION/ DROPS	1	13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
24208-505-05	ML - Milliliter	24208-505	44ac8321-a27d-412e-834f-8a1e759e6a33	1	2012-07-24
24208-505-10	ML - Milliliter	24208-505	4adf571a-1809-4cba-bc0a-32726f7ea26b	1	2012-07-24
24208-505-15	ML - Milliliter	24208-505	fa5bfc0a-39b6-40a2-8e70-5b8e02fabc62	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LEVOBUNOLOL HYDROCHLORIDE	ACTIVE INGREDIENT	O90S49LDHH	LEVOBUNOLOL HYDROCHLORIDE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]	7
LEVOBUNOLOL	ACTIVE MOIETY	G6317AOI7K	LEVOBUNOLOL HYDROCHLORIDE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]	7
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	LEVOBUNOLOL HYDROCHLORIDE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]	7
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	LEVOBUNOLOL HYDROCHLORIDE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]	7
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	LEVOBUNOLOL HYDROCHLORIDE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]	7
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	LEVOBUNOLOL HYDROCHLORIDE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]	7
POTASSIUM PHOSPHATE, MONOBASIC	INACTIVE INGREDIENT	4J9FJ0HL51	LEVOBUNOLOL HYDROCHLORIDE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]	7
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	LEVOBUNOLOL HYDROCHLORIDE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]	7
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	LEVOBUNOLOL HYDROCHLORIDE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]	7
SODIUM METABISULFITE	INACTIVE INGREDIENT	4VON5FNS3C	LEVOBUNOLOL HYDROCHLORIDE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]	7
SODIUM PHOSPHATE, DIBASIC	INACTIVE INGREDIENT	GR686LBA74	LEVOBUNOLOL HYDROCHLORIDE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]	7
WATER	INACTIVE INGREDIENT	059QF0KO0R	LEVOBUNOLOL HYDROCHLORIDE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]	7
LEVOBUNOLOL HYDROCHLORIDE	ACTIVE INGREDIENT	O90S49LDHH	LEVOBUNOLOL HYDROCHLORIDE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]	1
LEVOBUNOLOL	ACTIVE MOIETY	G6317AOI7K	LEVOBUNOLOL HYDROCHLORIDE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]	1
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	LEVOBUNOLOL HYDROCHLORIDE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	LEVOBUNOLOL HYDROCHLORIDE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]	1
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	LEVOBUNOLOL HYDROCHLORIDE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]	1
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	LEVOBUNOLOL HYDROCHLORIDE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]	1
POTASSIUM PHOSPHATE, MONOBASIC	INACTIVE INGREDIENT	4J9FJ0HL51	LEVOBUNOLOL HYDROCHLORIDE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	LEVOBUNOLOL HYDROCHLORIDE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	LEVOBUNOLOL HYDROCHLORIDE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]	1
SODIUM METABISULFITE	INACTIVE INGREDIENT	4VON5FNS3C	LEVOBUNOLOL HYDROCHLORIDE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]	1
SODIUM PHOSPHATE, DIBASIC	INACTIVE INGREDIENT	GR686LBA74	LEVOBUNOLOL HYDROCHLORIDE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	LEVOBUNOLOL HYDROCHLORIDE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
24208-505	LEVOBUNOLOL HYDROCHLORIDE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]	13	Current NDC, Legacy NDC, 6 package rows	20240725_5ab1efbe-530b-4787-b40a-c7dbf18161e1.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
Levobunolol Hydrochloride	LEVOBUNOLOL HYDROCHLORIDE	Bausch & Lomb Incorporated	5ab1efbe-530b-4787-b40a-c7dbf18161e1	2024-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074326 application number: ANDA074326 ndc (product): 24208-505

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
O90S49LDHH	LEVOBUNOLOL HYDROCHLORIDE	27912-14-7	LEVOBUNOLOL HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1150836	levobunolol HCl 0.5 % Ophthalmic Solution	PSN	5ab1efbe-530b-4787-b40a-c7dbf18161e1	13
1150836	levobunolol hydrochloride 5 MG/ML Ophthalmic Solution	SCD	5ab1efbe-530b-4787-b40a-c7dbf18161e1	13
1150836	levobunolol hydrochloride 0.5 % Ophthalmic Solution	SY	5ab1efbe-530b-4787-b40a-c7dbf18161e1	13
1150836	levobunolol HCl 0.5 % Ophthalmic Solution	PSN	bf29d224-0ab2-41fa-92d9-3f7520c525b2	1
1150836	levobunolol hydrochloride 5 MG/ML Ophthalmic Solution	SCD	bf29d224-0ab2-41fa-92d9-3f7520c525b2	1
1150836	levobunolol hydrochloride 0.5 % Ophthalmic Solution	SY	bf29d224-0ab2-41fa-92d9-3f7520c525b2	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
24208-505-05	24208050505	1 BOTTLE, DROPPER in 1 CARTON (24208-505-05) / 5 mL in 1 BOTTLE, DROPPER	1994-03-04	0000-00-00	No	No	Current
24208-505-10	24208050510	1 BOTTLE, DROPPER in 1 CARTON (24208-505-10) / 10 mL in 1 BOTTLE, DROPPER	1994-03-04	0000-00-00	No	No	Current
24208-505-15	24208050515	1 BOTTLE, DROPPER in 1 CARTON (24208-505-15) / 15 mL in 1 BOTTLE, DROPPER	1994-03-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Levobunolol Hydrochloride Ophthalmic Solution, USP 0.5% (Sterile) Rx only FOR USE IN THE EYES ONLY	Bausch & Lomb Incorporated	2024-07-24	HUMAN PRESCRIPTION DRUG LABEL	13
Levobunolol Hydrochloride Ophthalmic Solution	Physicians Total Care, Inc.	2012-06-12	HUMAN PRESCRIPTION DRUG LABEL	1