FDA.reportPublic FDA data

Prednisone

Product NDC
66267-860
11-digit product format
662670860
Labeler code
66267
Product ID
66267-860_1fa773d7-02b1-11c3-e063-6394a90ac730
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisone
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA040362
Marketing category
ANDA
Marketing start
2001-08-29
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66267-860-032023-06-01C16284748780-1f386c64a-3c05-0266-e053-dadaa90a7c1aPredniSONE Tablets, USP Rx only
66267-860-062023-06-01C16284748780-1f386c64a-3c05-0266-e053-dadaa90a7c1aPredniSONE Tablets, USP Rx only
66267-860-102023-06-01C16284748780-1f386c64a-3c05-0266-e053-dadaa90a7c1aPredniSONE Tablets, USP Rx only
66267-860-032023-01-30C16284748780-1f386c64a-3c05-0266-e053-dadaa90a7c1aPredniSONE Tablets, USP Rx only
66267-860-062023-01-30C16284748780-1f386c64a-3c05-0266-e053-dadaa90a7c1aPredniSONE Tablets, USP Rx only
66267-860-102023-01-30C16284748780-1f386c64a-3c05-0266-e053-dadaa90a7c1aPredniSONE Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66267-860-03Prednisone3 in 1 BOTTLETABLET38
66267-860-04Prednisone4 in 1 BOTTLETABLET48
66267-860-06Prednisone6 in 1 BOTTLETABLET68
66267-860-10Prednisone10 in 1 BOTTLETABLET108

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66267-860-04EA - Each66267-86046b46bbd-4792-4f15-b422-227debe8604512023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66267-860PREDNISONE TABLET [NUCARE PHARMACEUTICALS,INC.]8Current NDC, Legacy NDC, 4 package rows20240816_62fdf3c2-cfa9-d573-e053-2a91aa0a833b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312615predniSONE 20 MG Oral TabletPSN62fdf3c2-cfa9-d573-e053-2a91aa0a833b8
312615prednisone 20 MG Oral TabletSCD62fdf3c2-cfa9-d573-e053-2a91aa0a833b8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66267-860-03662670860033 TABLET in 1 BOTTLE (66267-860-03) 3 tablet2018-01-170000-00-00NoNoCurrent
66267-860-04662670860044 TABLET in 1 BOTTLE (66267-860-04) 4 tablet2018-01-17NoNoHistorical
66267-860-06662670860066 TABLET in 1 BOTTLE (66267-860-06) 6 tablet2018-01-170000-00-00NoNoCurrent
66267-860-106626708601010 TABLET in 1 BOTTLE (66267-860-10) 10 tablet2018-01-170000-00-00NoNoCurrent