MIEBO

Product NDC
24208-377
11-digit product format
242080377
Labeler code
24208
Product ID
24208-377_4cb37a53-376f-ef57-e063-6294a90a5bf8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Perfluorohexyloctane
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Bausch & Lomb Incorporated
Application
NDA216675
Marketing category
NDA
Marketing start
2023-05-18
Substance
PERFLUOROHEXYLOCTANE
Active strength
1 mg/mg
Pharmacologic classes
Semifluorinated Alkane [EPC], Semifluorinated Alkane [EXT]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
MIEBO
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PERFLUOROHEXYLOCTANE1 mg/mg

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7VYX4ELWQM
Rxcui2637551, 2637556

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
142abbd4-fedd-4103-a709-8bb94a1a4fe1Product name120231011

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24208-377-01MIEBO1 in 1 CARTONSOLUTION112
24208-377-01MIEBO3 mg in 1 BOTTLESOLUTION312
24208-377-05MIEBO1 in 1 CARTONSOLUTION112
24208-377-05MIEBO3 mg in 1 BOTTLESOLUTION312
24208-377-06MIEBO1 in 1 CARTONSOLUTION112
24208-377-06MIEBO1.6 mg in 1 BOTTLESOLUTION1.612

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24208-377-05ML - Milliliter24208-377a2c1ddb9-6cb2-492e-bf79-c67c8eb5ea5712023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24208-377MIEBO (PERFLUOROHEXYLOCTANE) SOLUTION [BAUSCH & LOMB INCORPORATED]10Current NDC, 6 package rows20240719_6b283c02-7df4-4c00-951b-555cddffe77c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2637556Miebo 1.338 GM/mL Ophthalmic SolutionPSN6b283c02-7df4-4c00-951b-555cddffe77c12
2637551perfluorohexyloctane 1.338 GM/mL Ophthalmic SolutionPSN6b283c02-7df4-4c00-951b-555cddffe77c12
2637556perfluorohexyloctane 1340 MG/ML Ophthalmic Solution [Miebo]SBD6b283c02-7df4-4c00-951b-555cddffe77c12
2637551perfluorohexyloctane 1340 MG/ML Ophthalmic SolutionSCD6b283c02-7df4-4c00-951b-555cddffe77c12
2637556Miebo 1.338 GM/ML Ophthalmic SolutionSY6b283c02-7df4-4c00-951b-555cddffe77c12
2637556Miebo 1340 MG/ML Ophthalmic SolutionSY6b283c02-7df4-4c00-951b-555cddffe77c12
2637551perfluorohexyloctane 1.338 GM/ML Ophthalmic SolutionSY6b283c02-7df4-4c00-951b-555cddffe77c12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
24208-377-01242080377011 BOTTLE in 1 CARTON (24208-377-01) / 3 mg in 1 BOTTLE1 bottle2023-05-18YesNoHistorical
24208-377-05242080377051 BOTTLE in 1 CARTON (24208-377-05) / 3 mg in 1 BOTTLE1 bottle2023-05-18NoNoHistorical
24208-377-06242080377061 BOTTLE in 1 CARTON (24208-377-06) / 1.6 mg in 1 BOTTLE1 bottle2024-07-19YesNoHistorical