FDA.reportPublic FDA data

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVOBUNOLOL HYDROCHLORIDE5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiO90S49LDHH
Rxcui1150836

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
803345b7-00e4-b8c2-81f6-8628d34cb6aeProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24208-505-05Levobunolol Hydrochloride5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS513
24208-505-05Levobunolol Hydrochloride1 in 1 CARTONSOLUTION/ DROPS113
24208-505-10Levobunolol Hydrochloride1 in 1 CARTONSOLUTION/ DROPS113
24208-505-10Levobunolol Hydrochloride10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS1013
24208-505-15Levobunolol Hydrochloride15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS1513
24208-505-15Levobunolol Hydrochloride1 in 1 CARTONSOLUTION/ DROPS113

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24208-505-05ML - Milliliter24208-50544ac8321-a27d-412e-834f-8a1e759e6a3312012-07-24
24208-505-10ML - Milliliter24208-5054adf571a-1809-4cba-bc0a-32726f7ea26b12012-07-24
24208-505-15ML - Milliliter24208-505fa5bfc0a-39b6-40a2-8e70-5b8e02fabc6212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVOBUNOLOL HYDROCHLORIDEACTIVE INGREDIENTO90S49LDHHLEVOBUNOLOL HYDROCHLORIDE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]7
LEVOBUNOLOLACTIVE MOIETYG6317AOI7KLEVOBUNOLOL HYDROCHLORIDE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]7
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7LEVOBUNOLOL HYDROCHLORIDE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]7
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KLEVOBUNOLOL HYDROCHLORIDE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]7
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBLEVOBUNOLOL HYDROCHLORIDE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]7
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990LEVOBUNOLOL HYDROCHLORIDE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]7
POTASSIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT4J9FJ0HL51LEVOBUNOLOL HYDROCHLORIDE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]7
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XLEVOBUNOLOL HYDROCHLORIDE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]7
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ILEVOBUNOLOL HYDROCHLORIDE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]7
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CLEVOBUNOLOL HYDROCHLORIDE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]7
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74LEVOBUNOLOL HYDROCHLORIDE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]7
WATERINACTIVE INGREDIENT059QF0KO0RLEVOBUNOLOL HYDROCHLORIDE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]7
LEVOBUNOLOL HYDROCHLORIDEACTIVE INGREDIENTO90S49LDHHLEVOBUNOLOL HYDROCHLORIDE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]1
LEVOBUNOLOLACTIVE MOIETYG6317AOI7KLEVOBUNOLOL HYDROCHLORIDE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]1
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7LEVOBUNOLOL HYDROCHLORIDE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KLEVOBUNOLOL HYDROCHLORIDE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBLEVOBUNOLOL HYDROCHLORIDE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990LEVOBUNOLOL HYDROCHLORIDE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]1
POTASSIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT4J9FJ0HL51LEVOBUNOLOL HYDROCHLORIDE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XLEVOBUNOLOL HYDROCHLORIDE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ILEVOBUNOLOL HYDROCHLORIDE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]1
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CLEVOBUNOLOL HYDROCHLORIDE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]1
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74LEVOBUNOLOL HYDROCHLORIDE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RLEVOBUNOLOL HYDROCHLORIDE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24208-505LEVOBUNOLOL HYDROCHLORIDE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]13Current NDC, Legacy NDC, 6 package rows20240725_5ab1efbe-530b-4787-b40a-c7dbf18161e1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1150836levobunolol HCl 0.5 % Ophthalmic SolutionPSN5ab1efbe-530b-4787-b40a-c7dbf18161e113
1150836levobunolol hydrochloride 5 MG/ML Ophthalmic SolutionSCD5ab1efbe-530b-4787-b40a-c7dbf18161e113
1150836levobunolol hydrochloride 0.5 % Ophthalmic SolutionSY5ab1efbe-530b-4787-b40a-c7dbf18161e113
1150836levobunolol HCl 0.5 % Ophthalmic SolutionPSNbf29d224-0ab2-41fa-92d9-3f7520c525b21
1150836levobunolol hydrochloride 5 MG/ML Ophthalmic SolutionSCDbf29d224-0ab2-41fa-92d9-3f7520c525b21
1150836levobunolol hydrochloride 0.5 % Ophthalmic SolutionSYbf29d224-0ab2-41fa-92d9-3f7520c525b21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
24208-505-05242080505051 BOTTLE, DROPPER in 1 CARTON (24208-505-05) / 5 mL in 1 BOTTLE, DROPPER1994-03-040000-00-00NoNoCurrent
24208-505-10242080505101 BOTTLE, DROPPER in 1 CARTON (24208-505-10) / 10 mL in 1 BOTTLE, DROPPER1994-03-040000-00-00NoNoCurrent
24208-505-15242080505151 BOTTLE, DROPPER in 1 CARTON (24208-505-15) / 15 mL in 1 BOTTLE, DROPPER1994-03-040000-00-00NoNoCurrent