Home NDC 43598-888 Prednisone delayed release
Product NDC 43598-888
11-digit product format 435980888
Labeler code 43598
Product ID 43598-888_1da2eb36-ff47-3cf6-e845-67460ced05fb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Prednisone
Dosage form TABLET, DELAYED RELEASE
Route ORAL
Labeler Dr. Reddys Laboratories Inc.
Application ANDA218035
Marketing category ANDA
Marketing start 2026-08-12
Substance PREDNISONE
Active strength 5 mg/1
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 A218035-001 PREDNISONE PREDNISONE 5MG TABLET, DELAYED RELEASE / ORAL RS 2026-06-26
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 A218035-001 PREDNISONE 5MG TABLET, DELAYED RELEASE / ORAL RS 2026-06-26 84e616aacf4f…2026-08-18 06:07:40 2026-07 A218035-001 PREDNISONE 5MG TABLET, DELAYED RELEASE / ORAL RS 2026-06-26 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218035-001 PREDNISONE 5MG TABLET, DELAYED RELEASE / ORAL RS 2026-06-26 a50c72e98297…
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 Prednisone delayed release
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PREDNISONE 5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination VB0R961HZT Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1303135 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 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 43598-888-01 43598088801 1 BOTTLE in 1 CARTON (43598-888-01) / 100 TABLET, DELAYED RELEASE in 1 BOTTLE 1 bottle 2026-08-12 No No Current 43598-888-30 43598088830 1 BOTTLE in 1 CARTON (43598-888-30) / 30 TABLET, DELAYED RELEASE in 1 BOTTLE 1 bottle 2026-08-12 No No Current