Carteolol Hydrochloride

Product NDC
61314-238
11-digit product format
613140238
Labeler code
61314
Product ID
61314-238_c89793f0-318b-4481-8fc0-e9cb0dcc5244
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carteolol Hydrochloride
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Sandoz Inc
Application
ANDA075476
Marketing category
ANDA
Marketing start
2000-01-05
Substance
CARTEOLOL HYDROCHLORIDE
Active strength
10 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
Carteolol Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARTEOLOL HYDROCHLORIDE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4797W6I0T4
Rxcui978573

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a1850243-4250-1591-ccf6-1a6481ef7e2fProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61314-238-05Carteolol Hydrochloride5 mL in 1 BOTTLE, PLASTICSOLUTION56
61314-238-10Carteolol Hydrochloride10 mL in 1 BOTTLE, PLASTICSOLUTION106
61314-238-15Carteolol Hydrochloride15 mL in 1 BOTTLE, PLASTICSOLUTION156

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61314-238-05ML - Milliliter61314-23825ae6dcd-3159-491d-b857-2901c039496312012-07-24
61314-238-10ML - Milliliter61314-238859be098-b435-4ec5-b5fd-f4112ca4b64c12012-07-24
61314-238-15ML - Milliliter61314-23822fce40d-fa9d-45f2-aa29-afba1d7d986612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CARTEOLOL HYDROCHLORIDEACTIVE INGREDIENT4797W6I0T4CARTEOLOL HYDROCHLORIDE SOLUTION [SANDOZ INC.]3
CARTEOLOLACTIVE MOIETY8NF31401XGCARTEOLOL HYDROCHLORIDE SOLUTION [SANDOZ INC.]3
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7CARTEOLOL HYDROCHLORIDE SOLUTION [SANDOZ INC.]3
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBCARTEOLOL HYDROCHLORIDE SOLUTION [SANDOZ INC.]3
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XCARTEOLOL HYDROCHLORIDE SOLUTION [SANDOZ INC.]3
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ICARTEOLOL HYDROCHLORIDE SOLUTION [SANDOZ INC.]3
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74CARTEOLOL HYDROCHLORIDE SOLUTION [SANDOZ INC.]3
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWCARTEOLOL HYDROCHLORIDE SOLUTION [SANDOZ INC.]3
WATERINACTIVE INGREDIENT059QF0KO0RCARTEOLOL HYDROCHLORIDE SOLUTION [SANDOZ INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61314-238CARTEOLOL HYDROCHLORIDE SOLUTION [SANDOZ INC]6Current NDC, Legacy NDC, 3 package rows20220217_571fe550-399d-4296-835c-37aa1ab9b409.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978573carteolol HCl 1 % Ophthalmic SolutionPSN571fe550-399d-4296-835c-37aa1ab9b4096
978573carteolol hydrochloride 10 MG/ML Ophthalmic SolutionSCD571fe550-399d-4296-835c-37aa1ab9b4096
978573carteolol hydrochloride 1 % Ophthalmic SolutionSY571fe550-399d-4296-835c-37aa1ab9b4096

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61314-238-05613140238055 mL in 1 BOTTLE, PLASTIC (61314-238-05) 5 ml2000-01-050000-00-00NoNoCurrent
61314-238-106131402381010 mL in 1 BOTTLE, PLASTIC (61314-238-10) 10 ml2000-01-050000-00-00NoNoCurrent
61314-238-156131402381515 mL in 1 BOTTLE, PLASTIC (61314-238-15) 15 ml2000-01-050000-00-00NoNoCurrent