FDA.reportPublic FDA data

prednisolone acetate

Product NDC
60219-2551
11-digit product format
602192551
Labeler code
60219
Product ID
60219-2551_b184f928-3c7a-46a0-9c67-7d2946a37868
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
prednisolone acetate
Dosage form
SUSPENSION/ DROPS
Route
OPHTHALMIC
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA218256
Marketing category
ANDA
Marketing start
2025-06-13
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A218256-001PREDNISOLONE ACETATEPREDNISOLONE ACETATE1%SUSPENSION/DROPS / OPHTHALMICAB2025-06-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A218256-001AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A218256-001PREDNISOLONE ACETATE1%SUSPENSION/DROPS / OPHTHALMICAB2025-06-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218256-001PREDNISOLONE ACETATE1%SUSPENSION/DROPS / OPHTHALMICAB2025-06-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A218256-001PREDNISOLONE ACETATE1%SUSPENSION/DROPS / OPHTHALMICAB2025-06-116a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218256-001PREDNISOLONE ACETATE1%SUSPENSION/DROPS / OPHTHALMICAB2025-06-11a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A218256-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218256-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A218256-001AB16a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218256-001AB1a50c72e98297…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8B2807733DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1376336Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8d8e8f9b-4d65-426f-8c57-451001cdd849Available on FDA.report

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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60219-2551-1prednisolone acetate1 in 1 CARTONSUSPENSION/ DROPS17
60219-2551-1prednisolone acetate10 mL in 1 BOTTLE, PLASTICSUSPENSION/ DROPS107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60219-2551-1ML - Milliliter60219-2551c36df5c3-b0ca-42d5-8342-3cd026744b8712025-12-16

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
prednisolone acetatePREDNISOLONE ACETATEAmneal Pharmaceuticals NY LLC8d8e8f9b-4d65-426f-8c57-451001cdd8492025-06-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218256
application number: ANDA218256
ndc (product): 60219-2551

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1376336prednisoLONE acetate 1 % Ophthalmic SuspensionPSN8d8e8f9b-4d65-426f-8c57-451001cdd8497
1376336prednisolone acetate 10 MG/ML Ophthalmic SuspensionSCD8d8e8f9b-4d65-426f-8c57-451001cdd8497
1376336prednisolone acetate 1 % Ophthalmic SuspensionSY8d8e8f9b-4d65-426f-8c57-451001cdd8497

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
60219-2551-1602192551011 BOTTLE, PLASTIC in 1 CARTON (60219-2551-1) / 10 mL in 1 BOTTLE, PLASTIC2025-06-13NoNoCurrent