FDA.reportPublic FDA data

Millipred

Product NDC
23594-510
11-digit product format
235940510
Labeler code
23594
Product ID
23594-510_eb46d92c-aeeb-4ad5-93ba-48162bc8c043
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREDNISOLONE SODIUM PHOSPHATE
Dosage form
SOLUTION
Route
ORAL
Labeler
Cerecor, Inc.
Application
ANDA078465
Marketing category
ANDA
Marketing start
2014-03-01
Marketing end
0000-00-00
Substance
PREDNISOLONE SODIUM PHOSPHATE
Active strength
10 mg/5mL
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct23594-510DDiscontinued by firm2026-07-31
excluded packagepackage23594-51023594-510-08DDiscontinued by firm2026-07-31

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
A078465-001PREDNISOLONE SODIUM PHOSPHATEPREDNISOLONE SODIUM PHOSPHATEEQ 10MG BASE/5MLSOLUTION / ORALAARS2008-03-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078465-001AA

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A078465-001PREDNISOLONE SODIUM PHOSPHATEEQ 10MG BASE/5MLSOLUTION / ORALAARS2008-03-07a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A078465-001AA1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Prednisolone Sodium PhosphatePREDNISOLONE SODIUM PHOSPHATEPAI Holdings, LLC dba PAI Pharma93cd0ddd-1cf5-4064-9a4c-015819c0065a2025-02-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078465
application number: ANDA078465

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23594-510-08ML - Milliliter23594-510757666be-c67a-40f6-93d6-f17816dc379a12014-09-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PREDNISOLONE SODIUM PHOSPHATEACTIVE INGREDIENTIV021NXA9JMILLIPRED (PREDNISOLONE SODIUM PHOSPHATE) SOLUTION [ZYLERA PHARMACEUTICALS, LLC]2
PREDNISOLONEACTIVE MOIETY9PHQ9Y1OLMMILLIPRED (PREDNISOLONE SODIUM PHOSPHATE) SOLUTION [ZYLERA PHARMACEUTICALS, LLC]2