FDA.reportPublic FDA data

PREDNISOLONE ACETATE

Product NDC
60758-119
11-digit product format
607580119
Labeler code
60758
Product ID
60758-119_9bb24539-c1ac-4ce6-88a8-a5dfad588c27
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
prednisolone acetate
Dosage form
SUSPENSION/ DROPS
Route
OPHTHALMIC
Labeler
Pacific Pharma, 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
84b851da-be59-d750-14d1-e4d93cc3b4daProduct name920250630
3a7a0034-a88d-88c3-f43e-ea34c6a216deProduct name220250311
9dbc4744-f7be-4393-b71a-e1bfd8b97659Product name220250218
6a38bd75-79e3-96c0-1204-08a0282902aeProduct name420250128
4d6e22a5-3693-6edf-0179-2ab93aecbadbProduct name920240724
2194a6ab-15bb-de49-cced-f09e642b1b64Product name820240313
03452e68-2506-686e-a908-f2381c778fc6Product name520240307
9e44d9f9-cb87-3b0f-4c71-c8438d0dc2e5Product name220240102
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
bb41bc3a-c643-93c9-055f-a8f48f363af3Product name220190219
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
d7840f4c-f22a-4403-b5da-53ac6ac8fd90Product name120150728
ccc7bb05-654a-45d2-a0d6-09ab96ba531bProduct name220150611
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
18d57d04-4a34-a130-5dd5-b7fc47f3b567Product name120140508
379bc253-901a-e6e1-92b7-0fc574249e07Product name120140508
48b05f5d-d2fc-45ab-76e8-3cb5bd44890dProduct name120140508
4f6a8082-ae1e-0ff7-4dc0-77f9f0f7b70cProduct 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
8d3e992f-8ff7-c106-f7eb-1e2d5eb12025Product 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
60758-119-05PREDNISOLONE ACETATE1 in 1 CARTONSUSPENSION/ DROPS111
60758-119-05PREDNISOLONE ACETATE5 mL in 1 BOTTLE, DROPPERSUSPENSION/ DROPS511
60758-119-10PREDNISOLONE ACETATE10 mL in 1 BOTTLE, DROPPERSUSPENSION/ DROPS1011
60758-119-10PREDNISOLONE ACETATE1 in 1 CARTONSUSPENSION/ DROPS111
60758-119-15PREDNISOLONE ACETATE15 mL in 1 BOTTLE, DROPPERSUSPENSION/ DROPS1511
60758-119-15PREDNISOLONE ACETATE1 in 1 CARTONSUSPENSION/ DROPS111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60758-119-05ML - Milliliter60758-1190583cff3-db8a-4969-82eb-c9947fd1ba4112012-07-24
60758-119-10ML - Milliliter60758-1193e1bf846-dac5-439d-b5a3-be6d4a18c71712012-07-24
60758-119-15ML - Milliliter60758-1195377df34-3004-4e14-8fcd-1b41cca8692012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
prednisolone acetateACTIVE INGREDIENT8B2807733DPREDNISOLONE ACETATE SUSPENSION/ DROPS [H.J. HARKINS COMPANY, INC.]3
prednisolone acetateACTIVE INGREDIENT8B2807733DPREDNISOLONE ACETATE SUSPENSION/ DROPS [PACIFIC PHARMA, INC.]3
prednisoloneACTIVE MOIETY9PHQ9Y1OLMPREDNISOLONE ACETATE SUSPENSION/ DROPS [H.J. HARKINS COMPANY, INC.]3
prednisoloneACTIVE MOIETY9PHQ9Y1OLMPREDNISOLONE ACETATE SUSPENSION/ DROPS [PACIFIC PHARMA, INC.]3
benzalkonium chlorideINACTIVE INGREDIENTF5UM2KM3W7PREDNISOLONE ACETATE SUSPENSION/ DROPS [PACIFIC PHARMA, INC.]3
benzalkonium chlorideINACTIVE INGREDIENTF5UM2KM3W7PREDNISOLONE ACETATE SUSPENSION/ DROPS [H.J. HARKINS COMPANY, INC.]3
boric acidINACTIVE INGREDIENTR57ZHV85D4PREDNISOLONE ACETATE SUSPENSION/ DROPS [PACIFIC PHARMA, INC.]3
boric acidINACTIVE INGREDIENTR57ZHV85D4PREDNISOLONE ACETATE SUSPENSION/ DROPS [H.J. HARKINS COMPANY, INC.]3
edetate disodiumINACTIVE INGREDIENT7FLD91C86KPREDNISOLONE ACETATE SUSPENSION/ DROPS [PACIFIC PHARMA, INC.]3
edetate disodiumINACTIVE INGREDIENT7FLD91C86KPREDNISOLONE ACETATE SUSPENSION/ DROPS [H.J. HARKINS COMPANY, INC.]3
hypromellosesINACTIVE INGREDIENT3NXW29V3WOPREDNISOLONE ACETATE SUSPENSION/ DROPS [PACIFIC PHARMA, INC.]3
hypromellosesINACTIVE INGREDIENT3NXW29V3WOPREDNISOLONE ACETATE SUSPENSION/ DROPS [H.J. HARKINS COMPANY, INC.]3
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HPREDNISOLONE ACETATE SUSPENSION/ DROPS [PACIFIC PHARMA, INC.]3
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HPREDNISOLONE ACETATE SUSPENSION/ DROPS [H.J. HARKINS COMPANY, INC.]3
sodium bisulfiteINACTIVE INGREDIENTTZX5469Z6IPREDNISOLONE ACETATE SUSPENSION/ DROPS [PACIFIC PHARMA, INC.]3
sodium bisulfiteINACTIVE INGREDIENTTZX5469Z6IPREDNISOLONE ACETATE SUSPENSION/ DROPS [H.J. HARKINS COMPANY, INC.]3
sodium chlorideINACTIVE INGREDIENT451W47IQ8XPREDNISOLONE ACETATE SUSPENSION/ DROPS [H.J. HARKINS COMPANY, INC.]3
sodium chlorideINACTIVE INGREDIENT451W47IQ8XPREDNISOLONE ACETATE SUSPENSION/ DROPS [PACIFIC PHARMA, INC.]3
sodium citrateINACTIVE INGREDIENT1Q73Q2JULRPREDNISOLONE ACETATE SUSPENSION/ DROPS [H.J. HARKINS COMPANY, INC.]3
sodium citrateINACTIVE INGREDIENT1Q73Q2JULRPREDNISOLONE ACETATE SUSPENSION/ DROPS [PACIFIC PHARMA, INC.]3
waterINACTIVE INGREDIENT059QF0KO0RPREDNISOLONE ACETATE SUSPENSION/ DROPS [H.J. HARKINS COMPANY, INC.]3
waterINACTIVE INGREDIENT059QF0KO0RPREDNISOLONE ACETATE SUSPENSION/ DROPS [PACIFIC PHARMA, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60758-119PREDNISOLONE ACETATE SUSPENSION/ DROPS [PACIFIC PHARMA, INC.]10Current NDC, Legacy NDC, 6 package rows20240405_1474d1df-70b6-4b1e-86d1-3349aa6d42fb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1376336prednisoLONE acetate 1 % Ophthalmic SuspensionPSN1474d1df-70b6-4b1e-86d1-3349aa6d42fb11
1376336prednisolone acetate 10 MG/ML Ophthalmic SuspensionSCD1474d1df-70b6-4b1e-86d1-3349aa6d42fb11
1376336prednisolone acetate 1 % Ophthalmic SuspensionSY1474d1df-70b6-4b1e-86d1-3349aa6d42fb11
1376336prednisoLONE acetate 1 % Ophthalmic SuspensionPSN388abc87-cd5a-4e88-8675-7bf0c5ce7af58
1376336prednisolone acetate 10 MG/ML Ophthalmic SuspensionSCD388abc87-cd5a-4e88-8675-7bf0c5ce7af58
1376336prednisolone acetate 1 % Ophthalmic SuspensionSY388abc87-cd5a-4e88-8675-7bf0c5ce7af58
1376336prednisoLONE acetate 1 % Ophthalmic SuspensionPSNdd32d625-fb2f-4c51-89fe-cdccdf0201b95
1376336prednisolone acetate 10 MG/ML Ophthalmic SuspensionSCDdd32d625-fb2f-4c51-89fe-cdccdf0201b95
1376336prednisolone acetate 1 % Ophthalmic SuspensionSYdd32d625-fb2f-4c51-89fe-cdccdf0201b95
1376336prednisoLONE acetate 1 % Ophthalmic SuspensionPSNc77597c4-8add-4d2a-b8c1-e526cbe22dcb3
1376336prednisoLONE acetate 1 % Ophthalmic SuspensionPSNab72cf3d-7660-41b1-e053-2995a90a7f443
1376336prednisolone acetate 10 MG/ML Ophthalmic SuspensionSCDc77597c4-8add-4d2a-b8c1-e526cbe22dcb3
1376336prednisolone acetate 10 MG/ML Ophthalmic SuspensionSCDab72cf3d-7660-41b1-e053-2995a90a7f443
1376336prednisolone acetate 1 % Ophthalmic SuspensionSYab72cf3d-7660-41b1-e053-2995a90a7f443
1376336prednisolone acetate 1 % Ophthalmic SuspensionSYc77597c4-8add-4d2a-b8c1-e526cbe22dcb3
860107ketorolac tromethamine 0.5 % Ophthalmic SolutionPSNca7a8de8-9185-e89f-e053-2995a90a5e042
403818moxifloxacin HCl 0.5 % Ophthalmic SolutionPSNca7a8de8-9185-e89f-e053-2995a90a5e042
1376336prednisoLONE acetate 1 % Ophthalmic SuspensionPSN02fc6f0b-d053-49e1-82de-f272dd05d5292
1376336prednisoLONE acetate 1 % Ophthalmic SuspensionPSNca7a8de8-9185-e89f-e053-2995a90a5e042
860107ketorolac tromethamine 5 MG/ML Ophthalmic SolutionSCDca7a8de8-9185-e89f-e053-2995a90a5e042
403818moxifloxacin 5 MG/ML Ophthalmic SolutionSCDca7a8de8-9185-e89f-e053-2995a90a5e042
1376336prednisolone acetate 10 MG/ML Ophthalmic SuspensionSCD02fc6f0b-d053-49e1-82de-f272dd05d5292
1376336prednisolone acetate 10 MG/ML Ophthalmic SuspensionSCDca7a8de8-9185-e89f-e053-2995a90a5e042
860107ketorolac tromethamine 0.5 % Ophthalmic SolutionSYca7a8de8-9185-e89f-e053-2995a90a5e042
403818moxifloxacin (as moxifloxacin HCl) 0.5 % Ophthalmic SolutionSYca7a8de8-9185-e89f-e053-2995a90a5e042
1376336prednisolone acetate 1 % Ophthalmic SuspensionSYca7a8de8-9185-e89f-e053-2995a90a5e042
1376336prednisolone acetate 1 % Ophthalmic SuspensionSY02fc6f0b-d053-49e1-82de-f272dd05d5292
1376336prednisoLONE acetate 1 % Ophthalmic SuspensionPSN1cfb4f31-b1d9-2287-e063-6394a90a9a4d1
1376336prednisoLONE acetate 1 % Ophthalmic SuspensionPSN232e40a5-17c5-4cf3-9e3b-110a194ad4be1
1376336prednisolone acetate 10 MG/ML Ophthalmic SuspensionSCD1cfb4f31-b1d9-2287-e063-6394a90a9a4d1
1376336prednisolone acetate 10 MG/ML Ophthalmic SuspensionSCD232e40a5-17c5-4cf3-9e3b-110a194ad4be1
1376336prednisolone acetate 1 % Ophthalmic SuspensionSY232e40a5-17c5-4cf3-9e3b-110a194ad4be1
1376336prednisolone acetate 1 % Ophthalmic SuspensionSY1cfb4f31-b1d9-2287-e063-6394a90a9a4d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60758-119-05607580119051 BOTTLE, DROPPER in 1 CARTON (60758-119-05) / 5 mL in 1 BOTTLE, DROPPER1997-08-190000-00-00NoNoCurrent
60758-119-10607580119101 BOTTLE, DROPPER in 1 CARTON (60758-119-10) / 10 mL in 1 BOTTLE, DROPPER1997-08-190000-00-00NoNoCurrent
60758-119-15607580119151 BOTTLE, DROPPER in 1 CARTON (60758-119-15) / 15 mL in 1 BOTTLE, DROPPER1997-08-190000-00-00NoNoCurrent