FDA.reportPublic FDA data

Prednisone delayed release

Product NDC
43598-887
11-digit product format
435980887
Labeler code
43598
Product ID
43598-887_a9e0d98c-c1bf-62b0-67b3-3b8f8313b408
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisone
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Dr. Reddys Laboratories Inc.
Application
ANDA219477
Marketing category
ANDA
Marketing start
2025-12-15
Substance
PREDNISONE
Active strength
2 mg/1
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A219477-001PREDNISONEPREDNISONE1MGTABLET, DELAYED RELEASE / ORAL2025-10-01
A219477-002PREDNISONEPREDNISONE2MGTABLET, DELAYED RELEASE / ORAL2025-10-01

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
2026-08-18 06:07:402026-07A219477-001PREDNISONE1MGTABLET, DELAYED RELEASE / ORAL2025-10-01caaa826d4ba7…
2026-08-18 06:07:402026-07A219477-002PREDNISONE2MGTABLET, DELAYED RELEASE / ORAL2025-10-01caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A219477-001PREDNISONE1MGTABLET, DELAYED RELEASE / ORALRS2025-10-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A219477-002PREDNISONE2MGTABLET, DELAYED RELEASE / ORAL2025-10-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219477-001PREDNISONE1MGTABLET, DELAYED RELEASE / ORALRS2025-10-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219477-002PREDNISONE2MGTABLET, DELAYED RELEASE / ORAL2025-10-0131067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219477-001PREDNISONE1MGTABLET, DELAYED RELEASE / ORAL2025-10-01a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219477-002PREDNISONE2MGTABLET, DELAYED RELEASE / ORAL2025-10-01a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Prednisone delayed release
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PREDNISONE2 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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1303125Internal RxNorm lookup
1303132Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
01bdc479-1f1f-af94-837c-12e7e861321aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2205d503-be51-445b-bb34-c209cc557b3cProduct name520230105
9492a99d-61c8-491f-9086-1c6a7e98c040Product name620230105
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
205c2cdd-a63b-cbc9-6bcb-6be6001edf81Product name220170705

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43598-887-01Prednisone delayed release1 in 1 CARTONTABLET, DELAYED RELEASE14
43598-887-01Prednisone delayed release100 in 1 BOTTLETABLET, DELAYED RELEASE1004
43598-887-30Prednisone delayed release30 in 1 BOTTLETABLET, DELAYED RELEASE304
43598-887-30Prednisone delayed release1 in 1 CARTONTABLET, DELAYED RELEASE14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-887-30EA - Each43598-8871346ee5c-c809-4a64-9a48-fd9df7fd781612026-01-08

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Prednisone delayed releasePREDNISONEINA Pharmaceutics Inc463c7cd2-c973-5c6c-e063-6394a90a09a02025-12-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219477
application number: ANDA219477
Prednisone delayed releasePREDNISONEDr. Reddys Laboratories Inc.01bdc479-1f1f-af94-837c-12e7e861321a2025-12-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219477
application number: ANDA219477
ndc (product): 43598-887

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1303125predniSONE 1 MG Delayed Release Oral TabletPSN01bdc479-1f1f-af94-837c-12e7e861321a4
1303132predniSONE 2 MG Delayed Release Oral TabletPSN01bdc479-1f1f-af94-837c-12e7e861321a4
1303125prednisone 1 MG Delayed Release Oral TabletSCD01bdc479-1f1f-af94-837c-12e7e861321a4
1303132prednisone 2 MG Delayed Release Oral TabletSCD01bdc479-1f1f-af94-837c-12e7e861321a4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
43598-887-01435980887011 BOTTLE in 1 CARTON (43598-887-01) / 100 TABLET, DELAYED RELEASE in 1 BOTTLE1 bottle2025-12-15NoNoCurrent
43598-887-30435980887301 BOTTLE in 1 CARTON (43598-887-30) / 30 TABLET, DELAYED RELEASE in 1 BOTTLE1 bottle2025-12-15NoNoCurrent