FDA.reportPublic FDA data

Prednisone

Product NDC
71610-834
11-digit product format
716100834
Labeler code
71610
Product ID
71610-834_50c260d6-5f22-7dd9-e063-6294a90abacd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisone
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA211575
Marketing category
ANDA
Marketing start
2023-02-01
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

Additional Listing Data#

Finished product
Yes
Brand name base
Prednisone
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PREDNISONE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVB0R961HZT
Rxcui312617

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
71610-834-30Prednisone30 in 1 BOTTLETABLET303
71610-834-53Prednisone60 in 1 BOTTLETABLET603
71610-834-60Prednisone90 in 1 BOTTLETABLET903
71610-834-80Prednisone180 in 1 BOTTLETABLET1803

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-834-30EA - Each71610-83498b0ca21-d941-48fc-a306-6871ec4257b212024-07-12
71610-834-53EA - Each71610-834bb8ecbe5-ddc6-4689-829b-3aef6a5c1a3412024-07-12
71610-834-60EA - Each71610-8345c93e6e5-2d78-466a-b45d-1239fb887b0612024-07-12
71610-834-80EA - Each71610-8341d3b6564-70b0-4bc8-abc0-3e37fa93564112024-09-09

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312617predniSONE 5 MG Oral TabletPSN18818282-68aa-82e9-e063-6394a90aef543
312617prednisone 5 MG Oral TabletSCD18818282-68aa-82e9-e063-6394a90aef543

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-834-307161008343030 TABLET in 1 BOTTLE (71610-834-30) 30 tablet2024-05-13NoNoHistorical
71610-834-537161008345360 TABLET in 1 BOTTLE (71610-834-53) 60 tablet2024-05-13NoNoHistorical
71610-834-607161008346090 TABLET in 1 BOTTLE (71610-834-60) 90 tablet2024-05-13NoNoHistorical
71610-834-8071610083480180 TABLET in 1 BOTTLE (71610-834-80) 180 tablet2024-07-18NoNoHistorical