FDA.reportPublic FDA data

PREDNISOLONE ACETATE

Product NDC
68071-2222
11-digit product format
680712222
Labeler code
68071
Product ID
68071-2222_1d7617a8-dae4-7892-e063-6294a90a3f9f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
prednisolone acetate
Dosage form
SUSPENSION/ DROPS
Route
OPHTHALMIC
Labeler
NuCare Pharmaceuticals,Inc.
Application
NDA017011
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
1997-08-19
Substance
PREDNISOLONE ACETATE
Active strength
10 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
PREDNISOLONE ACETATE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PREDNISOLONE ACETATE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8B2807733D
Rxcui1376336

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b3fecff3-fb51-4f66-b443-a130905bb500Product name120250804
3a7a0034-a88d-88c3-f43e-ea34c6a216deProduct name220250311
9dbc4744-f7be-4393-b71a-e1bfd8b97659Product name220250218
9e44d9f9-cb87-3b0f-4c71-c8438d0dc2e5Product name220240102
a0e37fa3-7f16-4fbf-bdb7-ae82cb1a553aProduct name120170309
af7d3306-1338-423f-839e-419aad9e8a86Product name120170309
18d57d04-4a34-a130-5dd5-b7fc47f3b567Product name120140508
379bc253-901a-e6e1-92b7-0fc574249e07Product name120140508
48b05f5d-d2fc-45ab-76e8-3cb5bd44890dProduct name120140508
73adedd8-aba8-27d9-78d9-2e3c4a3cf954Product name120140508
9ae74339-0a3d-82e9-5dd1-88bd2607bd6bProduct name120140508
9f10552a-9a7b-8e6c-3223-dc44310af6cfProduct name120140508
e44e38a9-2d9e-b0e2-cce9-490554639f3dProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-2222-52022-02-04C16284748780-1d6a99b39-ac5d-a426-e053-dadaa90af4c2PREDNISOLONE ACETATE ophthalmic suspension, USP 1% sterile
68071-2222-52022-01-28C16284748780-1d6a99b39-ac5d-a426-e053-dadaa90af4c2PREDNISOLONE ACETATE ophthalmic suspension, USP 1% sterile

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2222-5PREDNISOLONE ACETATE5 mL in 1 BOTTLE, DROPPERSUSPENSION/ DROPS53
68071-2222-5PREDNISOLONE ACETATE1 in 1 CARTONSUSPENSION/ DROPS13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2222PREDNISOLONE ACETATE SUSPENSION/ DROPS [NUCARE PHARMACEUTICALS,INC.]3Current NDC, Legacy NDC, 2 package rows20240719_ab72cf3d-7660-41b1-e053-2995a90a7f44.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1376336prednisoLONE acetate 1 % Ophthalmic SuspensionPSNab72cf3d-7660-41b1-e053-2995a90a7f443
1376336prednisolone acetate 10 MG/ML Ophthalmic SuspensionSCDab72cf3d-7660-41b1-e053-2995a90a7f443
1376336prednisolone acetate 1 % Ophthalmic SuspensionSYab72cf3d-7660-41b1-e053-2995a90a7f443

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-2222-5680712222051 BOTTLE, DROPPER in 1 CARTON (68071-2222-5) / 5 mL in 1 BOTTLE, DROPPER2020-07-270000-00-00NoNoCurrent