FDA.reportPublic FDA data

fluorometholone ophthalmic suspension

Product NDC
60219-1585
11-digit product format
602191585
Labeler code
60219
Product ID
60219-1585_6cb30deb-0a3d-4686-bcab-3f7cfbe5ac23
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluorometholone
Dosage form
SUSPENSION/ DROPS
Route
OPHTHALMIC
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA216348
Marketing category
ANDA
Marketing start
2023-01-09
Substance
FLUOROMETHOLONE
Active strength
1 mg/mL
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
fluorometholone ophthalmic suspension
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUOROMETHOLONE1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSV0CSG527L
Rxcui310377

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c643e98c-5dd1-707b-ab13-ba8a33389ab5Product name220250107
61e7d0c4-a2cb-3453-1dbf-f036c240eae7Product name120140508
8ad2c55d-f8c3-a60f-1dff-eb2b216dc767Product name120140508
e516fbca-d3ac-e281-609f-a30f67b308edProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60219-1585-3fluorometholone ophthalmic suspension1 in 1 CARTONSUSPENSION/ DROPS16
60219-1585-3fluorometholone ophthalmic suspension5 mL in 1 BOTTLE, DROPPERSUSPENSION/ DROPS56

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60219-1585-3ML - Milliliter60219-1585ab7efae6-aa61-4c10-95bf-87755c529e7812024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60219-1585FLUOROMETHOLONE OPHTHALMIC SUSPENSION (FLUOROMETHOLONE) SUSPENSION/ DROPS [AMNEAL PHARMACEUTICALS NY LLC]6Current NDC, 2 package rows20240112_e7988a3b-e432-4d42-a8d2-63ca017e6a01.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310377fluorometholone 0.1 % Ophthalmic SuspensionPSNe7988a3b-e432-4d42-a8d2-63ca017e6a016
310377fluorometholone 1 MG/ML Ophthalmic SuspensionSCDe7988a3b-e432-4d42-a8d2-63ca017e6a016
310377fluorometholone 0.1 % Ophthalmic SuspensionSYe7988a3b-e432-4d42-a8d2-63ca017e6a016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
60219-1585-3602191585031 BOTTLE, DROPPER in 1 CARTON (60219-1585-3) / 5 mL in 1 BOTTLE, DROPPER2023-01-09NoNoCurrent