FDA.reportPublic FDA data

Prednisolone Acetate

Product NDC
61314-637
11-digit product format
613140637
Labeler code
61314
Product ID
61314-637_32f12438-f75f-459e-a41f-34dcc8a9e4f7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisolone Acetate
Dosage form
SUSPENSION/ DROPS
Route
OPHTHALMIC
Labeler
Sandoz Inc
Application
NDA017469
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
1994-12-15
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
e42b5738-f3b2-36cb-547c-d658794618bcProduct name220250804
84b851da-be59-d750-14d1-e4d93cc3b4daProduct name920250630
3a7a0034-a88d-88c3-f43e-ea34c6a216deProduct name220250311
9dbc4744-f7be-4393-b71a-e1bfd8b97659Product name220250218
6a38bd75-79e3-96c0-1204-08a0282902aeProduct name420250128
4ce8f27b-067c-45ad-b8f6-4b29ec66e497Product name220250115
b81a1117-443d-49e4-a709-58c3c32468afProduct name520241010
4d6e22a5-3693-6edf-0179-2ab93aecbadbProduct name920240724
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
2194a6ab-15bb-de49-cced-f09e642b1b64Product name820240313
03452e68-2506-686e-a908-f2381c778fc6Product name520240307
9e44d9f9-cb87-3b0f-4c71-c8438d0dc2e5Product name220240102
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
bb41bc3a-c643-93c9-055f-a8f48f363af3Product name220190219
a0e37fa3-7f16-4fbf-bdb7-ae82cb1a553aProduct name120170309
af7d3306-1338-423f-839e-419aad9e8a86Product name120170309
ee6f8cae-1597-1a7e-3fb9-6aaeba954efeProduct name320150902
d7840f4c-f22a-4403-b5da-53ac6ac8fd90Product name120150728
ccc7bb05-654a-45d2-a0d6-09ab96ba531bProduct name220150611
8442aba0-7521-47cb-8a4e-c9896f35e8aeProduct name320150317
18d57d04-4a34-a130-5dd5-b7fc47f3b567Product name120140508
379bc253-901a-e6e1-92b7-0fc574249e07Product name120140508
48b05f5d-d2fc-45ab-76e8-3cb5bd44890dProduct name120140508
4f6a8082-ae1e-0ff7-4dc0-77f9f0f7b70cProduct name120140508
73adedd8-aba8-27d9-78d9-2e3c4a3cf954Product name120140508
8d3e992f-8ff7-c106-f7eb-1e2d5eb12025Product 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
61314-637-05Prednisolone Acetate5 mL in 1 BOTTLE, PLASTICSUSPENSION/ DROPS57
61314-637-05Prednisolone Acetate1 in 1 CARTONSUSPENSION/ DROPS17
61314-637-10Prednisolone Acetate1 in 1 CARTONSUSPENSION/ DROPS17
61314-637-10Prednisolone Acetate10 mL in 1 BOTTLE, PLASTICSUSPENSION/ DROPS107
61314-637-15Prednisolone Acetate1 in 1 CARTONSUSPENSION/ DROPS17
61314-637-15Prednisolone Acetate15 mL in 1 BOTTLE, PLASTICSUSPENSION/ DROPS157

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61314-637-05ML - Milliliter61314-637687ac068-dec0-4b7c-b191-c23c1e8fcb1112012-07-24
61314-637-10ML - Milliliter61314-637f2f42340-ae54-4b6a-b488-cbc294ba98a212012-07-24
61314-637-15ML - Milliliter61314-6371b82c78e-4257-4c55-a503-631aebe636f312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PREDNISOLONE ACETATEACTIVE INGREDIENT8B2807733DPREDNISOLONE ACETATE SUSPENSION [FALCON PHARMACEUTICALS]2
PREDNISOLONE ACETATEACTIVE INGREDIENT8B2807733DPREDNISOLONE ACETATE SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
PREDNISOLONEACTIVE MOIETY9PHQ9Y1OLMPREDNISOLONE ACETATE SUSPENSION [FALCON PHARMACEUTICALS]2
PREDNISOLONEACTIVE MOIETY9PHQ9Y1OLMPREDNISOLONE ACETATE SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7PREDNISOLONE ACETATE SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7PREDNISOLONE ACETATE SUSPENSION [FALCON PHARMACEUTICALS]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPPREDNISOLONE ACETATE SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPPREDNISOLONE ACETATE SUSPENSION [FALCON PHARMACEUTICALS]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KPREDNISOLONE ACETATE SUSPENSION [FALCON PHARMACEUTICALS]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KPREDNISOLONE ACETATE SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPREDNISOLONE ACETATE SUSPENSION [FALCON PHARMACEUTICALS]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPREDNISOLONE ACETATE SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPREDNISOLONE ACETATE SUSPENSION [FALCON PHARMACEUTICALS]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPREDNISOLONE ACETATE SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HPREDNISOLONE ACETATE SUSPENSION [FALCON PHARMACEUTICALS]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HPREDNISOLONE ACETATE SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IPREDNISOLONE ACETATE SUSPENSION [FALCON PHARMACEUTICALS]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IPREDNISOLONE ACETATE SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74PREDNISOLONE ACETATE SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74PREDNISOLONE ACETATE SUSPENSION [FALCON PHARMACEUTICALS]2
WATERINACTIVE INGREDIENT059QF0KO0RPREDNISOLONE ACETATE SUSPENSION [FALCON PHARMACEUTICALS]2
WATERINACTIVE INGREDIENT059QF0KO0RPREDNISOLONE ACETATE SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61314-637PREDNISOLONE ACETATE SUSPENSION/ DROPS [SANDOZ INC]7Current NDC, Legacy NDC, 6 package rows20250108_05d205c7-8f51-46b9-a6c5-4199bc432b26.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1376336prednisoLONE acetate 1 % Ophthalmic SuspensionPSNb1d30a4f-4941-45a5-bd24-fea07f1bfc8714
1376336prednisolone acetate 10 MG/ML Ophthalmic SuspensionSCDb1d30a4f-4941-45a5-bd24-fea07f1bfc8714
1376336prednisolone acetate 1 % Ophthalmic SuspensionSYb1d30a4f-4941-45a5-bd24-fea07f1bfc8714
1376336prednisoLONE acetate 1 % Ophthalmic SuspensionPSN48d8fd35-51e7-4592-b901-46dd7e8e32b89
1376336prednisolone acetate 10 MG/ML Ophthalmic SuspensionSCD48d8fd35-51e7-4592-b901-46dd7e8e32b89
1376336prednisolone acetate 1 % Ophthalmic SuspensionSY48d8fd35-51e7-4592-b901-46dd7e8e32b89
1376336prednisoLONE acetate 1 % Ophthalmic SuspensionPSN05d205c7-8f51-46b9-a6c5-4199bc432b267
1376336prednisolone acetate 10 MG/ML Ophthalmic SuspensionSCD05d205c7-8f51-46b9-a6c5-4199bc432b267
1376336prednisolone acetate 1 % Ophthalmic SuspensionSY05d205c7-8f51-46b9-a6c5-4199bc432b267
1376336prednisoLONE acetate 1 % Ophthalmic SuspensionPSNb17d2a0e-5f89-4253-9a8a-bb6ec59919fe2
1376336prednisolone acetate 10 MG/ML Ophthalmic SuspensionSCDb17d2a0e-5f89-4253-9a8a-bb6ec59919fe2
1376336prednisolone acetate 1 % Ophthalmic SuspensionSYb17d2a0e-5f89-4253-9a8a-bb6ec59919fe2
578018bromfenac 0.09 % Ophthalmic SolutionPSN2df9064c-0527-4c21-e063-6294a90a56d81
860107ketorolac tromethamine 0.5 % Ophthalmic SolutionPSN249b0f15-9c13-90e2-e063-6394a90a1fd51
403818moxifloxacin HCl 0.5 % Ophthalmic SolutionPSN2df9064c-0527-4c21-e063-6294a90a56d81
403818moxifloxacin HCl 0.5 % Ophthalmic SolutionPSN249b0f15-9c13-90e2-e063-6394a90a1fd51
1376336prednisoLONE acetate 1 % Ophthalmic SuspensionPSN96232353-7a98-374d-e053-2a95a90a05691
1376336prednisoLONE acetate 1 % Ophthalmic SuspensionPSN1fbfceac-51ba-5d82-e063-6394a90a71ee1
1376336prednisoLONE acetate 1 % Ophthalmic SuspensionPSN249b0f15-9c13-90e2-e063-6394a90a1fd51
1376336prednisoLONE acetate 1 % Ophthalmic SuspensionPSN2df9064c-0527-4c21-e063-6294a90a56d81
578018bromfenac 0.9 MG/ML Ophthalmic SolutionSCD2df9064c-0527-4c21-e063-6294a90a56d81
860107ketorolac tromethamine 5 MG/ML Ophthalmic SolutionSCD249b0f15-9c13-90e2-e063-6394a90a1fd51
403818moxifloxacin 5 MG/ML Ophthalmic SolutionSCD2df9064c-0527-4c21-e063-6294a90a56d81
403818moxifloxacin 5 MG/ML Ophthalmic SolutionSCD249b0f15-9c13-90e2-e063-6394a90a1fd51
1376336prednisolone acetate 10 MG/ML Ophthalmic SuspensionSCD2df9064c-0527-4c21-e063-6294a90a56d81
1376336prednisolone acetate 10 MG/ML Ophthalmic SuspensionSCD96232353-7a98-374d-e053-2a95a90a05691
1376336prednisolone acetate 10 MG/ML Ophthalmic SuspensionSCD1fbfceac-51ba-5d82-e063-6394a90a71ee1
1376336prednisolone acetate 10 MG/ML Ophthalmic SuspensionSCD249b0f15-9c13-90e2-e063-6394a90a1fd51
578018bromfenac 0.09 % Ophthalmic SolutionSY2df9064c-0527-4c21-e063-6294a90a56d81
578018bromfenac 0.9 MG/ML (bromfenac sodium 1.035 MG/ML) Ophthalmic SolutionSY2df9064c-0527-4c21-e063-6294a90a56d81
860107ketorolac tromethamine 0.5 % Ophthalmic SolutionSY249b0f15-9c13-90e2-e063-6394a90a1fd51
403818moxifloxacin (as moxifloxacin HCl) 0.5 % Ophthalmic SolutionSY2df9064c-0527-4c21-e063-6294a90a56d81
403818moxifloxacin (as moxifloxacin HCl) 0.5 % Ophthalmic SolutionSY249b0f15-9c13-90e2-e063-6394a90a1fd51
1376336prednisolone acetate 1 % Ophthalmic SuspensionSY2df9064c-0527-4c21-e063-6294a90a56d81
1376336prednisolone acetate 1 % Ophthalmic SuspensionSY1fbfceac-51ba-5d82-e063-6394a90a71ee1
1376336prednisolone acetate 1 % Ophthalmic SuspensionSY96232353-7a98-374d-e053-2a95a90a05691
1376336prednisolone acetate 1 % Ophthalmic SuspensionSY249b0f15-9c13-90e2-e063-6394a90a1fd51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61314-637-05613140637051 BOTTLE, PLASTIC in 1 CARTON (61314-637-05) / 5 mL in 1 BOTTLE, PLASTIC1994-12-150000-00-00NoNoCurrent
61314-637-10613140637101 BOTTLE, PLASTIC in 1 CARTON (61314-637-10) / 10 mL in 1 BOTTLE, PLASTIC1994-12-150000-00-00NoNoCurrent
61314-637-15613140637151 BOTTLE, PLASTIC in 1 CARTON (61314-637-15) / 15 mL in 1 BOTTLE, PLASTIC1994-12-150000-00-00NoNoCurrent