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

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 Identifiers#

Field, Values table
FieldValues
UniiVB0R961HZT
Rxcui1303125, 1303132

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

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 bottle2025-12-15NoNoHistorical
43598-887-30435980887301 BOTTLE in 1 CARTON (43598-887-30) / 30 TABLET, DELAYED RELEASE in 1 BOTTLE1 bottle2025-12-15NoNoHistorical