FDA.reportPublic FDA data

Prednisone delayed release

Product NDC
43598-888
Requested package NDC
43598-888-01
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A218035-001PREDNISONEPREDNISONE5MGTABLET, DELAYED RELEASE / ORALRS2026-06-26

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A218035-001PREDNISONE5MGTABLET, DELAYED RELEASE / ORALRS2026-06-2684e616aacf4f…
2026-08-18 06:07:402026-07A218035-001PREDNISONE5MGTABLET, DELAYED RELEASE / ORALRS2026-06-26caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218035-001PREDNISONE5MGTABLET, DELAYED RELEASE / ORALRS2026-06-26a50c72e98297…

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
IngredientStrength
PREDNISONE5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
VB0R961HZTInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1303135Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
474974ac-9811-c9f5-4050-58e535351d00Available on FDA.report

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Prednisone delayed releasePREDNISONEDr. Reddys Laboratories Inc.474974ac-9811-c9f5-4050-58e535351d002026-04-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218035
application number: ANDA218035
ndc (package): 43598-888-01
ndc (product): 43598-888
ndc11 (package): 43598088801

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
43598-888-01435980888011 BOTTLE in 1 CARTON (43598-888-01) / 100 TABLET, DELAYED RELEASE in 1 BOTTLE1 bottle2026-08-12NoNoCurrent