Home NDC 52817-860 Prednisolone
Product NDC 52817-860
11-digit product format 528170860
Labeler code 52817
Product ID 52817-860_5a84db26-98d0-fe51-e063-6294a90a63ee
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Prednisolone oral
Dosage form SOLUTION
Route ORAL
Labeler TRUPHARMA, LLC
Application ANDA219509
Marketing category ANDA
Marketing start 2026-08-04
Substance PREDNISOLONE
Active strength 15 mg/5mL
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A219509-001 PREDNISOLONE PREDNISOLONE 15MG/5ML SOLUTION / ORAL AA 2025-06-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A219509-001 AA
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A219509-001 PREDNISOLONE 15MG/5ML SOLUTION / ORAL AA 2025-06-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 A219509-001 PREDNISOLONE 15MG/5ML SOLUTION / ORAL AA 2025-06-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A219509-001 PREDNISOLONE 15MG/5ML SOLUTION / ORAL AA 2025-06-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219509-001 PREDNISOLONE 15MG/5ML SOLUTION / ORAL AA 2025-06-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A219509-001 PREDNISOLONE 15MG/5ML SOLUTION / ORAL AA 2025-06-23 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219509-001 PREDNISOLONE 15MG/5ML SOLUTION / ORAL AA 2025-06-23 a50c72e98297…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Prednisolone
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PREDNISOLONE 15 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9PHQ9Y1OLM Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 283077 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 · 2 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 52817-860-08 52817086008 240 mL in 1 BOTTLE (52817-860-08) 240 ml 2026-08-04 No No Current 52817-860-16 52817086016 480 mL in 1 BOTTLE (52817-860-16) 480 ml 2026-08-04 No No Current