FDA.reportPublic FDA data

prednisone

Product NDC
71335-2079
11-digit product format
713352079
Labeler code
71335
Product ID
71335-2079_2a5ad2f0-8a26-4514-8498-a66afc78d169
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREDNISONE
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA208412
Marketing category
ANDA
Marketing start
2021-09-01
Substance
PREDNISONE
Active strength
20 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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PREDNISONE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVB0R961HZT
Rxcui312615

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
71335-2079-0prednisone11 in 1 BOTTLE, PLASTICTABLET11104
71335-2079-1prednisone20 in 1 BOTTLE, PLASTICTABLET20104
71335-2079-2prednisone30 in 1 BOTTLE, PLASTICTABLET30104
71335-2079-3prednisone40 in 1 BOTTLE, PLASTICTABLET40104
71335-2079-4prednisone15 in 1 BOTTLE, PLASTICTABLET15104
71335-2079-5prednisone10 in 1 BOTTLE, PLASTICTABLET10104
71335-2079-6prednisone21 in 1 BOTTLE, PLASTICTABLET21104
71335-2079-7prednisone18 in 1 BOTTLE, PLASTICTABLET18104
71335-2079-8prednisone12 in 1 BOTTLE, PLASTICTABLET12104
71335-2079-9prednisone23 in 1 BOTTLE, PLASTICTABLET23104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2079-1EA - Each71335-2079d678af35-8409-497c-ad51-5a1c1298c4b312023-01-09
71335-2079-5EA - Each71335-20792241a95f-8279-4be5-a185-305c3fba574312025-08-11
71335-2079-6EA - Each71335-20792ed9f5cb-08e8-4114-9895-65019ee0df5112024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2079PREDNISONE TABLET [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 10 package rows20240809_4433a882-ff79-4a9d-8db8-1977c5cd04cf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312615predniSONE 20 MG Oral TabletPSN4433a882-ff79-4a9d-8db8-1977c5cd04cf104
312615prednisone 20 MG Oral TabletSCD4433a882-ff79-4a9d-8db8-1977c5cd04cf104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-2079-07133520790011 TABLET in 1 BOTTLE, PLASTIC (71335-2079-0) 11 tablet2022-05-030000-00-00NoNoCurrent
71335-2079-17133520790120 TABLET in 1 BOTTLE, PLASTIC (71335-2079-1) 20 tablet2022-05-060000-00-00NoNoCurrent
71335-2079-27133520790230 TABLET in 1 BOTTLE, PLASTIC (71335-2079-2) 30 tablet2022-05-310000-00-00NoNoCurrent
71335-2079-37133520790340 TABLET in 1 BOTTLE, PLASTIC (71335-2079-3) 40 tablet2022-09-060000-00-00NoNoCurrent
71335-2079-47133520790415 TABLET in 1 BOTTLE, PLASTIC (71335-2079-4) 15 tablet2022-06-090000-00-00NoNoCurrent
71335-2079-57133520790510 TABLET in 1 BOTTLE, PLASTIC (71335-2079-5) 10 tablet2022-04-270000-00-00NoNoCurrent
71335-2079-67133520790621 TABLET in 1 BOTTLE, PLASTIC (71335-2079-6) 21 tablet2022-06-020000-00-00NoNoCurrent
71335-2079-77133520790718 TABLET in 1 BOTTLE, PLASTIC (71335-2079-7) 18 tablet2022-06-230000-00-00NoNoCurrent
71335-2079-87133520790812 TABLET in 1 BOTTLE, PLASTIC (71335-2079-8) 12 tablet2022-04-180000-00-00NoNoCurrent
71335-2079-97133520790923 TABLET in 1 BOTTLE, PLASTIC (71335-2079-9) 23 tablet2024-04-030000-00-00NoNoCurrent