FDA.reportPublic FDA data

MILLIPRED

Product NDC
23594-505
11-digit product format
235940505
Labeler code
23594
Product ID
23594-505_87447266-eb4d-4ee3-9acf-21780745b84b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREDNISOLONE
Dosage form
TABLET
Route
ORAL
Labeler
Aytu Therapeutics
Application
ANDA080354
Marketing category
ANDA
Marketing start
2014-03-01
Marketing end
0000-00-00
Substance
PREDNISOLONE
Active strength
5 mg/1
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
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 productproduct23594-505DDiscontinued by firm2026-07-31
excluded packagepackage23594-50523594-505-01DDiscontinued 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
A080354-001PREDNISOLONEPREDNISOLONE5MGTABLET / ORALABRLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A080354-001AB

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 22:54:322026-06A080354-001PREDNISOLONE5MGTABLET / ORALABRLD, RS, Approved before 1982a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A080354-001AB1a50c72e98297…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
23594-505-012024-07-22C16284748780-1f386c649-dde4-0266-e053-dadaa90a7c1aMILLIPRED™ Tablet (prednisolone tablets USP) Rx only
23594-505-012023-01-30C16284748780-1f386c649-dde4-0266-e053-dadaa90a7c1aMILLIPRED™ Tablet (prednisolone tablets USP) Rx only

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23594-505-01EA - Each23594-505d7e52157-6fe1-44a4-b441-78f146e65bd612014-11-05
23594-505-02EA - Each23594-505aaed4853-5713-46bb-a9ac-be85256384bf12018-01-12
23594-505-21EA - Each23594-50550ef71be-4e42-43dd-b357-aeb09fdc2bc412014-11-05
23594-505-48EA - Each23594-5055d345d05-dc46-4ee1-b354-fea2bcfd100512014-11-05
23594-505-50EA - Each23594-505fbdbe945-7a3b-45d7-87af-b8eb5faad6db12016-05-16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PREDNISOLONEACTIVE INGREDIENT9PHQ9Y1OLMMILLIPRED (PREDNISOLONE) TABLET [ZYLERA PHARMACEUTICALS, LLC]5
PREDNISOLONEACTIVE MOIETY9PHQ9Y1OLMMILLIPRED (PREDNISOLONE) TABLET [ZYLERA PHARMACEUTICALS, LLC]5
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKMILLIPRED (PREDNISOLONE) TABLET [ZYLERA PHARMACEUTICALS, LLC]5
CROSPOVIDONEINACTIVE INGREDIENT68401960MKMILLIPRED (PREDNISOLONE) TABLET [ZYLERA PHARMACEUTICALS, LLC]5
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GMILLIPRED (PREDNISOLONE) TABLET [ZYLERA PHARMACEUTICALS, LLC]5
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0MILLIPRED (PREDNISOLONE) TABLET [ZYLERA PHARMACEUTICALS, LLC]5
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8MILLIPRED (PREDNISOLONE) TABLET [ZYLERA PHARMACEUTICALS, LLC]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MILLIPRED (PREDNISOLONE) TABLET [ZYLERA PHARMACEUTICALS, LLC]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MILLIPRED (PREDNISOLONE) TABLET [ZYLERA PHARMACEUTICALS, LLC]5
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUMILLIPRED (PREDNISOLONE) TABLET [ZYLERA PHARMACEUTICALS, LLC]5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
23594-505-0123594050501100 TABLET in 1 BOTTLE (23594-505-01) 100 tablet2014-03-010000-00-00NoNoCurrent