FDA.reportPublic FDA data

Prednisone

Product NDC
66267-172
11-digit product format
662670172
Labeler code
66267
Product ID
66267-172_10f56bf8-3a4b-81e4-e063-6294a90aef03
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
5 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
PREDNISONE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVB0R961HZT

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
66267-172-102023-12-06C16284748780-1f386c64a-0071-0266-e053-dadaa90a7c1aPredniSONE Tablets, USP Rx only
66267-172-152023-12-06C16284748780-1f386c64a-0071-0266-e053-dadaa90a7c1aPredniSONE Tablets, USP Rx only
66267-172-202023-12-06C16284748780-1f386c64a-0071-0266-e053-dadaa90a7c1aPredniSONE Tablets, USP Rx only
66267-172-212023-12-06C16284748780-1f386c64a-0071-0266-e053-dadaa90a7c1aPredniSONE Tablets, USP Rx only
66267-172-302023-12-06C16284748780-1f386c64a-0071-0266-e053-dadaa90a7c1aPredniSONE Tablets, USP Rx only
66267-172-402023-12-06C16284748780-1f386c64a-0071-0266-e053-dadaa90a7c1aPredniSONE Tablets, USP Rx only
66267-172-102023-01-30C16284748780-1f386c64a-0071-0266-e053-dadaa90a7c1aPredniSONE Tablets, USP Rx only
66267-172-152023-01-30C16284748780-1f386c64a-0071-0266-e053-dadaa90a7c1aPredniSONE Tablets, USP Rx only
66267-172-202023-01-30C16284748780-1f386c64a-0071-0266-e053-dadaa90a7c1aPredniSONE Tablets, USP Rx only
66267-172-212023-01-30C16284748780-1f386c64a-0071-0266-e053-dadaa90a7c1aPredniSONE Tablets, USP Rx only
66267-172-302023-01-30C16284748780-1f386c64a-0071-0266-e053-dadaa90a7c1aPredniSONE Tablets, USP Rx only
66267-172-402023-01-30C16284748780-1f386c64a-0071-0266-e053-dadaa90a7c1aPredniSONE Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66267-172-06Prednisone6 in 1 BOTTLETABLET69
66267-172-08Prednisone8 in 1 BOTTLETABLET89
66267-172-10Prednisone10 in 1 BOTTLETABLET109
66267-172-14Prednisone14 in 1 BOTTLETABLET149
66267-172-15Prednisone15 in 1 BOTTLETABLET159
66267-172-20Prednisone20 in 1 BOTTLETABLET209
66267-172-21Prednisone21 in 1 BOTTLETABLET219
66267-172-30Prednisone30 in 1 BOTTLETABLET309
66267-172-40Prednisone40 in 1 BOTTLETABLET409

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66267-172-10EA - Each66267-172b22d33c0-9323-4e40-bba0-7be5faa4885a12018-02-20
66267-172-15EA - Each66267-17291deb63b-d0ff-4f88-8986-d1f16461ffac12018-02-20
66267-172-20EA - Each66267-172915efc0f-26c3-4b0d-b73a-4aa112b578e212018-02-20
66267-172-30EA - Each66267-17206366a8f-00d1-4a02-9099-b389888f622412018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66267-172PREDNISONE TABLET [NUCARE PHARMACEUTICALS,INC.]9Current NDC, Legacy NDC, 9 package rows20240210_63102d75-9b2b-84a9-e053-2a91aa0a317d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66267-172-06662670172066 TABLET in 1 BOTTLE (66267-172-06) 6 tablet2018-01-18NoNoHistorical
66267-172-08662670172088 TABLET in 1 BOTTLE (66267-172-08) 8 tablet2018-01-18NoNoHistorical
66267-172-106626701721010 TABLET in 1 BOTTLE (66267-172-10) 10 tablet2018-01-180000-00-00NoNoCurrent
66267-172-146626701721414 TABLET in 1 BOTTLE (66267-172-14) 14 tablet2018-01-18NoNoHistorical
66267-172-156626701721515 TABLET in 1 BOTTLE (66267-172-15) 15 tablet2018-01-180000-00-00NoNoCurrent
66267-172-206626701722020 TABLET in 1 BOTTLE (66267-172-20) 20 tablet2018-01-180000-00-00NoNoCurrent
66267-172-216626701722121 TABLET in 1 BOTTLE (66267-172-21) 21 tablet2018-01-180000-00-00NoNoCurrent
66267-172-306626701723030 TABLET in 1 BOTTLE (66267-172-30) 30 tablet2018-01-180000-00-00NoNoCurrent
66267-172-406626701724040 TABLET in 1 BOTTLE (66267-172-40) 40 tablet2018-01-180000-00-00NoNoCurrent