PRED MILD

Product NDC
11980-174
11-digit product format
119800174
Labeler code
11980
Product ID
11980-174_02594e74-d6cf-40b5-bfb1-c27be33e0e35
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
prednisolone acetate
Dosage form
SUSPENSION/ DROPS
Route
OPHTHALMIC
Labeler
Allergan, Inc.
Application
NDA017100
Marketing category
NDA
Marketing start
1972-12-01
Substance
PREDNISOLONE ACETATE
Active strength
1.2 mg/mL
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PRED MILD
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PREDNISOLONE ACETATE1.2 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8B2807733D
Rxcui209002, 562379

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
11980-174-05PRED MILD5 mL in 1 BOTTLE, DROPPERSUSPENSION/ DROPS516
11980-174-05PRED MILD1 in 1 CARTONSUSPENSION/ DROPS116
11980-174-10PRED MILD1 in 1 CARTONSUSPENSION/ DROPS116
11980-174-10PRED MILD10 mL in 1 BOTTLE, DROPPERSUSPENSION/ DROPS1016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11980-174-05ML - Milliliter11980-174424bea18-66e6-468a-9177-543c5bb6df9112012-07-24
11980-174-10ML - Milliliter11980-174f8179da6-de60-4166-962d-99032510e7e312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
prednisolone acetateACTIVE INGREDIENT8B2807733DPRED MILD (PREDNISOLONE ACETATE) SUSPENSION/ DROPS [ALLERGAN, INC.]4
prednisoloneACTIVE MOIETY9PHQ9Y1OLMPRED MILD (PREDNISOLONE ACETATE) SUSPENSION/ DROPS [ALLERGAN, INC.]4
benzalkonium chlorideINACTIVE INGREDIENTF5UM2KM3W7PRED MILD (PREDNISOLONE ACETATE) SUSPENSION/ DROPS [ALLERGAN, INC.]4
boric acidINACTIVE INGREDIENTR57ZHV85D4PRED MILD (PREDNISOLONE ACETATE) SUSPENSION/ DROPS [ALLERGAN, INC.]4
edetate disodiumINACTIVE INGREDIENT7FLD91C86KPRED MILD (PREDNISOLONE ACETATE) SUSPENSION/ DROPS [ALLERGAN, INC.]4
hypromellosesINACTIVE INGREDIENT3NXW29V3WOPRED MILD (PREDNISOLONE ACETATE) SUSPENSION/ DROPS [ALLERGAN, INC.]4
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HPRED MILD (PREDNISOLONE ACETATE) SUSPENSION/ DROPS [ALLERGAN, INC.]4
sodium bisulfiteINACTIVE INGREDIENTTZX5469Z6IPRED MILD (PREDNISOLONE ACETATE) SUSPENSION/ DROPS [ALLERGAN, INC.]4
sodium chlorideINACTIVE INGREDIENT451W47IQ8XPRED MILD (PREDNISOLONE ACETATE) SUSPENSION/ DROPS [ALLERGAN, INC.]4
sodium citrateINACTIVE INGREDIENT1Q73Q2JULRPRED MILD (PREDNISOLONE ACETATE) SUSPENSION/ DROPS [ALLERGAN, INC.]4
waterINACTIVE INGREDIENT059QF0KO0RPRED MILD (PREDNISOLONE ACETATE) SUSPENSION/ DROPS [ALLERGAN, INC.]4
prednisolone acetateACTIVE INGREDIENT8B2807733DPRED MILD (PREDNISOLONE ACETATE) SUSPENSION/ DROPS [PHYSICIANS TOTAL CARE, INC.]1
prednisoloneACTIVE MOIETY9PHQ9Y1OLMPRED MILD (PREDNISOLONE ACETATE) SUSPENSION/ DROPS [PHYSICIANS TOTAL CARE, INC.]1
benzalkonium chlorideINACTIVE INGREDIENTF5UM2KM3W7PRED MILD (PREDNISOLONE ACETATE) SUSPENSION/ DROPS [PHYSICIANS TOTAL CARE, INC.]1
boric acidINACTIVE INGREDIENTR57ZHV85D4PRED MILD (PREDNISOLONE ACETATE) SUSPENSION/ DROPS [PHYSICIANS TOTAL CARE, INC.]1
edetate disodiumINACTIVE INGREDIENT7FLD91C86KPRED MILD (PREDNISOLONE ACETATE) SUSPENSION/ DROPS [PHYSICIANS TOTAL CARE, INC.]1
hypromellosesINACTIVE INGREDIENT3NXW29V3WOPRED MILD (PREDNISOLONE ACETATE) SUSPENSION/ DROPS [PHYSICIANS TOTAL CARE, INC.]1
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HPRED MILD (PREDNISOLONE ACETATE) SUSPENSION/ DROPS [PHYSICIANS TOTAL CARE, INC.]1
sodium bisulfiteINACTIVE INGREDIENTTZX5469Z6IPRED MILD (PREDNISOLONE ACETATE) SUSPENSION/ DROPS [PHYSICIANS TOTAL CARE, INC.]1
sodium chlorideINACTIVE INGREDIENT451W47IQ8XPRED MILD (PREDNISOLONE ACETATE) SUSPENSION/ DROPS [PHYSICIANS TOTAL CARE, INC.]1
sodium citrateINACTIVE INGREDIENT1Q73Q2JULRPRED MILD (PREDNISOLONE ACETATE) SUSPENSION/ DROPS [PHYSICIANS TOTAL CARE, INC.]1
waterINACTIVE INGREDIENT059QF0KO0RPRED MILD (PREDNISOLONE ACETATE) SUSPENSION/ DROPS [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11980-174PRED MILD (PREDNISOLONE ACETATE) SUSPENSION/ DROPS [ALLERGAN, INC.]13Current NDC, Legacy NDC, 4 package rows20240306_4fcce64a-94ea-4031-ad5a-c4eddc73a910.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
209002PRED MILD 0.12 % Ophthalmic SuspensionPSN4fcce64a-94ea-4031-ad5a-c4eddc73a91016
562379prednisoLONE acetate 0.12 % Ophthalmic SuspensionPSN4fcce64a-94ea-4031-ad5a-c4eddc73a91016
209002prednisolone 1.2 MG/ML Ophthalmic Suspension [Pred Mild]SBD4fcce64a-94ea-4031-ad5a-c4eddc73a91016
562379prednisolone 1.2 MG/ML Ophthalmic SuspensionSCD4fcce64a-94ea-4031-ad5a-c4eddc73a91016
209002Pred Mild 0.12 % Ophthalmic SuspensionSY4fcce64a-94ea-4031-ad5a-c4eddc73a91016
209002Pred Mild 1.2 MG/ML Ophthalmic SuspensionSY4fcce64a-94ea-4031-ad5a-c4eddc73a91016
562379prednisolone 0.12 % Ophthalmic SuspensionSY4fcce64a-94ea-4031-ad5a-c4eddc73a91016
209002PRED MILD 0.12 % Ophthalmic SuspensionPSN4c1ec8d2-9128-402e-a723-87dc7b4446551
562379prednisoLONE acetate 0.12 % Ophthalmic SuspensionPSN4c1ec8d2-9128-402e-a723-87dc7b4446551
209002prednisolone 1.2 MG/ML Ophthalmic Suspension [Pred Mild]SBD4c1ec8d2-9128-402e-a723-87dc7b4446551
562379prednisolone 1.2 MG/ML Ophthalmic SuspensionSCD4c1ec8d2-9128-402e-a723-87dc7b4446551
209002Pred Mild 0.12 % Ophthalmic SuspensionSY4c1ec8d2-9128-402e-a723-87dc7b4446551
209002Pred Mild 1.2 MG/ML Ophthalmic SuspensionSY4c1ec8d2-9128-402e-a723-87dc7b4446551
562379prednisolone 0.12 % Ophthalmic SuspensionSY4c1ec8d2-9128-402e-a723-87dc7b4446551

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
11980-174-05119800174051 BOTTLE, DROPPER in 1 CARTON (11980-174-05) / 5 mL in 1 BOTTLE, DROPPER1972-12-010000-00-00NoNoCurrent
11980-174-10119800174101 BOTTLE, DROPPER in 1 CARTON (11980-174-10) / 10 mL in 1 BOTTLE, DROPPER1972-12-010000-00-00NoNoCurrent