Prednisone delayed release

Product NDC
74157-019
11-digit product format
741570019
Labeler code
74157
Product ID
74157-019_463c5b39-7eb2-d396-e063-6394a90aa451
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisone
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
INA Pharmaceutics 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
205c2cdd-a63b-cbc9-6bcb-6be6001edf81Product name220170705

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74157-019-30Prednisone delayed release30 in 1 BOTTLETABLET, DELAYED RELEASE301
74157-019-30Prednisone delayed release1 in 1 CARTONTABLET, DELAYED RELEASE11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
74157-019-30EA - Each74157-0194ea9eaa9-54c8-48e2-b8b9-a929c18fdeab12026-01-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1303125predniSONE 1 MG Delayed Release Oral TabletPSN463c7cd2-c973-5c6c-e063-6394a90a09a01
1303132predniSONE 2 MG Delayed Release Oral TabletPSN463c7cd2-c973-5c6c-e063-6394a90a09a01
1303125prednisone 1 MG Delayed Release Oral TabletSCD463c7cd2-c973-5c6c-e063-6394a90a09a01
1303132prednisone 2 MG Delayed Release Oral TabletSCD463c7cd2-c973-5c6c-e063-6394a90a09a01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
74157-019-30741570019301 BOTTLE in 1 CARTON (74157-019-30) / 30 TABLET, DELAYED RELEASE in 1 BOTTLE1 bottle2025-12-15NoNoHistorical