FDA.reportPublic FDA data

NDC 0121-0687-16 - PrednisoLONE

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0121-0687
Requested NDC
0121-0687-16
Package NDCs from labels
0121-0687-08, 0121-0687-16, 0121-0687-05
Manufacturer
Pharmaceutical Associates, Inc.
Effective date
2007-08-09
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
PrednisoLONE - Pharmaceutical Associates, Inc.Pharmaceutical Associates, Inc.2007-08-09Human Prescription Drug Label

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0121-0687PREDNISOLONE (PREDNISOLONE) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]1Unmatched20080313_42be491e-f3f2-45b5-9432-dd7bceea2fa4.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PrednisoloneACTIVE INGREDIENT9PHQ9Y1OLMPREDNISOLONE (PREDNISOLONE) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]1
PrednisoloneACTIVE MOIETY9PHQ9Y1OLMPREDNISOLONE (PREDNISOLONE) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]1
AlcoholINACTIVE INGREDIENT3K9958V90MPREDNISOLONE (PREDNISOLONE) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]1
Artificial Berry FlavorINACTIVE INGREDIENTPREDNISOLONE (PREDNISOLONE) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]1
Citric Acid AnhydrousINACTIVE INGREDIENTPREDNISOLONE (PREDNISOLONE) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]1
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86KPREDNISOLONE (PREDNISOLONE) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]1
FD&C Blue No. 1INACTIVE INGREDIENTPREDNISOLONE (PREDNISOLONE) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]1
FD&C Red No. 40INACTIVE INGREDIENTPREDNISOLONE (PREDNISOLONE) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]1
GlycerinINACTIVE INGREDIENTPDC6A3C0OXPREDNISOLONE (PREDNISOLONE) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]1
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3PREDNISOLONE (PREDNISOLONE) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]1
Sodium BenzoateINACTIVE INGREDIENTOJ245FE5EUPREDNISOLONE (PREDNISOLONE) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]1
Sodium SaccharinINACTIVE INGREDIENTPREDNISOLONE (PREDNISOLONE) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]1
SucroseINACTIVE INGREDIENTC151H8M554PREDNISOLONE (PREDNISOLONE) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RPREDNISOLONE (PREDNISOLONE) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]1

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 ยท 20 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Prednisolone Sodium PhosphatePREDNISOLONE SODIUM PHOSPHATEATLANTIC BIOLOGICALS CORP.96de9cad-2fb7-4947-87ae-4db57563a83a2026-09-04Warnings, Adverse reactionsExact identifier
rxcui: 283077
PrednisolonePREDNISOLONE ORALTRUPHARMA, LLC4f83514d-5342-4748-a0d3-b0306ca303c82026-09-02Warnings, Adverse reactionsExact identifier
rxcui: 283077
Prednisolone Sodium PhosphatePREDNISOLONE SODIUM PHOSPHATEPreferred Pharmaceuticals, Inc.93b372f7-b811-4c15-85c4-c6dbac342cb42026-08-18Warnings, Adverse reactionsExact identifier
rxcui: 283077
PrednisolonePREDNISOLONE ORALTulex Pharmaceuticals Inc757b41c4-a0fe-4a09-8816-a4cdb7558f412026-07-08Warnings, Adverse reactionsExact identifier
rxcui: 283077
Prednisolone Sodium PhosphatePREDNISOLONE SODIUM PHOSPHATEREMEDYREPACK INC.f87ce1ba-335e-463d-87d5-9af0206f8f612026-02-10Warnings, Adverse reactionsExact identifier
rxcui: 283077
PrednisolonePREDNISOLONEA-S Medication Solutions35f0b197-c3ae-445a-8da7-9ffcd4472e052026-01-23Warnings, Adverse reactionsExact identifier
rxcui: 283077
Prednisolone Sodium PhosphatePREDNISOLONE SODIUM PHOSPHATERedpharm Drug3253b63b-0533-6cdc-e063-6294a90aa3112025-12-24Warnings, Adverse reactionsExact identifier
rxcui: 283077
Prednisolone Sodium PhosphatePREDNISOLONE SODIUM PHOSPHATEEdenbridge Pharmaceuticals LLC.1793e218-7b49-497d-879f-1020de6e6d682025-12-17Warnings, Adverse reactionsExact identifier
rxcui: 283077
PrednisolonePREDNISOLONE ORALChartwell Governmental & Specialty RX, LLC.2dac9898-6492-4f34-ad86-83a902e0fe0b2025-11-18Warnings, Adverse reactionsExact identifier
rxcui: 283077
Prednisolone Sodium PhosphatePREDNISOLONE SODIUM PHOSPHATEPreferred Pharmaceuticals Inc.7262fc84-3db2-4475-8ae4-6bec4477cb812025-10-28Warnings, Adverse reactionsExact identifier
rxcui: 283077
Prednisolone Sodium PhosphatePREDNISOLONE SODIUM PHOSPHATEAtlantic Biologicals Corp401f7ba6-a4a2-9ae6-e063-6394a90a42102025-10-01Warnings, Adverse reactionsExact identifier
rxcui: 283077
Prednisolone Sodium PhosphatePREDNISOLONE SODIUM PHOSPHATEPAI Holdings, LLC dba PAI Pharmaa0d74ae0-7b2d-4d36-9211-c76f5063b5a92025-07-10Warnings, Adverse reactionsExact identifier
rxcui: 283077
Prednisolone Sodium PhosphatePREDNISOLONE SODIUM PHOSPHATEAmneal Pharmaceuticals NY LLC286a6032-41de-435a-b6e6-14052b66b85d2025-04-29Warnings, Adverse reactionsExact identifier
rxcui: 283077
Prednisolone Sodium PhosphatePREDNISOLONE SODIUM PHOSPHATEA-S Medication Solutions4c507319-8add-4952-8bea-ff77ab17088f2025-02-28Warnings, Adverse reactionsExact identifier
rxcui: 283077
PrednisolonePREDNISOLONE ORAL SOLUTIONHeritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.b079834f-9aa3-4db9-bd53-de28e8f81c042025-02-18Warnings, Adverse reactionsExact identifier
rxcui: 283077
PrednisolonePREDNISOLONEPAI Holdings, LLC dba PAI Pharmacebd7b5b-8e9f-4de9-9fcf-8ee0661fede32024-08-19Warnings, Adverse reactionsExact identifier
rxcui: 283077
PrednisolonePREDNISOLONE ORALChartwell RX, LLCaa40f582-cced-4e6e-90f0-10ab310ab2a72024-06-03Warnings, Adverse reactionsExact identifier
rxcui: 283077
PrednisoLONEPREDNISOLONELannett Company, Inc.86652e2d-664a-4388-a611-c2a9aa4a4bc82024-02-14Warnings, Adverse reactionsExact identifier
rxcui: 283077
Prednisolone Sodium PhosphatePREDNISOLONE SODIUM PHOSPHATEProficient Rx LP14b7f41b-4df1-42cb-bd1b-c74b28de26702021-01-01Warnings, Adverse reactionsExact identifier
rxcui: 283077
8F16D5C0-E833-29F3-66AB-9A47A9DDBF5C42be491e-f3f2-45b5-9432-dd7bceea2fa42007-08-09Warnings, Adverse reactionsExact identifier
spl id: 8F16D5C0-E833-29F3-66AB-9A47A9DDBF5C
spl set id: 42be491e-f3f2-45b5-9432-dd7bceea2fa4

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.