PREDNISOLONE ACETATE

Product NDC
76420-204
11-digit product format
764200204
Labeler code
76420
Product ID
76420-204_d1fbb852-8bc5-7a0e-e053-2a95a90a2d8e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
prednisolone acetate
Dosage form
SUSPENSION/ DROPS
Route
OPHTHALMIC
Labeler
Asclemed USA, 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

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
N017011-001PRED FORTEPREDNISOLONE ACETATE1%SUSPENSION/DROPS / OPHTHALMICABRLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N017011-001AB

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.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N017011-001PRED FORTE1%SUSPENSION/DROPS / OPHTHALMICABRLD, RS, Approved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017011-001PRED FORTE1%SUSPENSION/DROPS / OPHTHALMICABRLD, RS, Approved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08N017011-001PRED FORTE1%SUSPENSION/DROPS / OPHTHALMICABRLD, RS, Approved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017011-001PRED FORTE1%SUSPENSION/DROPS / OPHTHALMICABRLD, RS, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017011-001PRED FORTE1%SUSPENSION/DROPS / OPHTHALMICABRLD, RS, Approved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017011-001PRED FORTE1%SUSPENSION/DROPS / OPHTHALMICABRLD, RS, Approved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017011-001PRED FORTE1%SUSPENSION/DROPS / OPHTHALMICABRLD, RS, Approved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017011-001PRED FORTE1%SUSPENSION/DROPS / OPHTHALMICABRLD, RS, Approved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017011-001PRED FORTE1%SUSPENSION/DROPS / OPHTHALMICABRLD, RS, Approved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N017011-001PRED FORTE1%SUSPENSION/DROPS / OPHTHALMICABRLD, RS, Approved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017011-001PRED FORTE1%SUSPENSION/DROPS / OPHTHALMICABRLD, RS, Approved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017011-001PRED FORTE1%SUSPENSION/DROPS / OPHTHALMICABRLD, RS, Approved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N017011-001PRED FORTE1%SUSPENSION/DROPS / OPHTHALMICABRLD, RS, Approved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05N017011-001PRED FORTE1%SUSPENSION/DROPS / OPHTHALMICABRLD, RS, Approved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N017011-001PRED FORTE1%SUSPENSION/DROPS / OPHTHALMICABRLD, RS, Approved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N017011-001PRED FORTE1%SUSPENSION/DROPS / OPHTHALMICABRLD, RS, Approved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N017011-001PRED FORTE1%SUSPENSION/DROPS / OPHTHALMICABRLD, RS, Approved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N017011-001PRED FORTE1%SUSPENSION/DROPS / OPHTHALMICABRLD, RS, Approved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N017011-001PRED FORTE1%SUSPENSION/DROPS / OPHTHALMICABRLD, RS, Approved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N017011-001PRED FORTE1%SUSPENSION/DROPS / OPHTHALMICABRLD, RS, Approved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N017011-001PRED FORTE1%SUSPENSION/DROPS / OPHTHALMICABRLD, RS, Approved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03N017011-001PRED FORTE1%SUSPENSION/DROPS / OPHTHALMICABRLD, RS, Approved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N017011-001PRED FORTE1%SUSPENSION/DROPS / OPHTHALMICABRLD, RS, Approved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11N017011-001PRED FORTE1%SUSPENSION/DROPS / OPHTHALMICABRLD, RS, Approved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12N017011-001PRED FORTE1%SUSPENSION/DROPS / OPHTHALMICABRLD, RS, Approved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09N017011-001PRED FORTE1%SUSPENSION/DROPS / OPHTHALMICABRLD, RS, Approved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07N017011-001PRED FORTE1%SUSPENSION/DROPS / OPHTHALMICABRLD, RS, Approved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N017011-001PRED FORTE1%SUSPENSION/DROPS / OPHTHALMICABRLD, RS, Approved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N017011-001PRED FORTE1%SUSPENSION/DROPS / OPHTHALMICABRLD, RS, Approved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12N017011-001PRED FORTE1%SUSPENSION/DROPS / OPHTHALMICABRLD, RS, Approved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N017011-001PRED FORTE1%SUSPENSION/DROPS / OPHTHALMICABRLD, RS, Approved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N017011-001PRED FORTE1%SUSPENSION/DROPS / OPHTHALMICABRLD, RS, Approved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N017011-001PRED FORTE1%SUSPENSION/DROPS / OPHTHALMICABRLD, RS, Approved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N017011-001PRED FORTE1%SUSPENSION/DROPS / OPHTHALMICABRLD, RS, Approved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05N017011-001PRED FORTE1%SUSPENSION/DROPS / OPHTHALMICABRLD, RS, Approved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01N017011-001PRED FORTE1%SUSPENSION/DROPS / OPHTHALMICABRLD, RS, Approved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N017011-001PRED FORTE1%SUSPENSION/DROPS / OPHTHALMICABRLD, RS, Approved before 19823a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N017011-001PRED FORTE1%SUSPENSION/DROPS / OPHTHALMICABRLD, RS, Approved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N017011-001PRED FORTE1%SUSPENSION/DROPS / OPHTHALMICABRLD, RS, Approved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N017011-001PRED FORTE1%SUSPENSION/DROPS / OPHTHALMICABRLD, RS, Approved before 1982cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N017011-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017011-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N017011-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017011-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017011-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017011-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017011-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017011-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017011-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N017011-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017011-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017011-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N017011-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N017011-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N017011-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N017011-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N017011-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N017011-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N017011-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N017011-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N017011-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N017011-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N017011-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N017011-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N017011-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N017011-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N017011-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N017011-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N017011-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N017011-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N017011-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N017011-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N017011-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N017011-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N017011-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N017011-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N017011-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N017011-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N017011-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N017011-001AB1cb3db0bc1861…

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
232e40a5-17c5-4cf3-9e3b-110a194ad4beAvailable 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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
a0e37fa3-7f16-4fbf-bdb7-ae82cb1a553aProduct name120170309
af7d3306-1338-423f-839e-419aad9e8a86Product name120170309
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
18d57d04-4a34-a130-5dd5-b7fc47f3b567Product name120140508
379bc253-901a-e6e1-92b7-0fc574249e07Product name120140508
48b05f5d-d2fc-45ab-76e8-3cb5bd44890dProduct name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
73adedd8-aba8-27d9-78d9-2e3c4a3cf954Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
9ae74339-0a3d-82e9-5dd1-88bd2607bd6bProduct name120140508
9f10552a-9a7b-8e6c-3223-dc44310af6cfProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
e44e38a9-2d9e-b0e2-cce9-490554639f3dProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76420-204-05PREDNISOLONE ACETATE1 in 1 CARTONSUSPENSION/ DROPS11
76420-204-05PREDNISOLONE ACETATE5 mL in 1 BOTTLE, DROPPERSUSPENSION/ DROPS51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-204PREDNISOLONE ACETATE SUSPENSION/ DROPS [ASCLEMED USA, INC.]1Current NDC, Legacy NDC, 2 package rows20211201_232e40a5-17c5-4cf3-9e3b-110a194ad4be.zip

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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PREDNISOLONE ACETATEPREDNISOLONE ACETATEA-S Medication Solutionsdd32d625-fb2f-4c51-89fe-cdccdf0201b92026-08-03Warnings, Adverse reactionsExact identifier
application applno (NDA): 017011
application number: NDA017011
PREDNISOLONE ACETATEPREDNISOLONE ACETATESportpharm LLC02fc6f0b-d053-49e1-82de-f272dd05d5292026-04-24Warnings, Adverse reactionsExact identifier
application applno (NDA): 017011
application number: NDA017011
PREDNISOLONE ACETATEPREDNISOLONE ACETATEA-S Medication Solutions388abc87-cd5a-4e88-8675-7bf0c5ce7af52024-10-14Warnings, Adverse reactionsExact identifier
application applno (NDA): 017011
application number: NDA017011
PREDNISOLONE ACETATEPREDNISOLONE ACETATENuCare Pharmaceuticals,Inc.ab72cf3d-7660-41b1-e053-2995a90a7f442024-07-17Warnings, Adverse reactionsExact identifier
application applno (NDA): 017011
application number: NDA017011
PREDNISOLONE ACETATEPREDNISOLONE ACETATEPacific Pharma, Inc.1474d1df-70b6-4b1e-86d1-3349aa6d42fb2024-03-19Warnings, Adverse reactionsExact identifier
application applno (NDA): 017011
application number: NDA017011
PRED FORTEPREDNISOLONE ACETATEAllergan, Inc.00a5aa88-e361-4ea7-8922-530c738b726e2024-02-02Warnings, Adverse reactionsExact identifier
application applno (NDA): 017011
application number: NDA017011
PREDNISOLONE ACETATEPREDNISOLONE ACETATEAsclemed USA, Inc.232e40a5-17c5-4cf3-9e3b-110a194ad4be2021-11-30Warnings, Adverse reactionsExact identifier
application applno (NDA): 017011
application number: NDA017011
ndc (product): 76420-204

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1376336prednisoLONE acetate 1 % Ophthalmic SuspensionPSN232e40a5-17c5-4cf3-9e3b-110a194ad4be1
1376336prednisolone acetate 10 MG/ML Ophthalmic SuspensionSCD232e40a5-17c5-4cf3-9e3b-110a194ad4be1
1376336prednisolone acetate 1 % Ophthalmic SuspensionSY232e40a5-17c5-4cf3-9e3b-110a194ad4be1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
76420-204-05764200204051 BOTTLE, DROPPER in 1 CARTON (76420-204-05) / 5 mL in 1 BOTTLE, DROPPER2021-11-300000-00-00NoNoCurrent