FDA.reportPublic FDA data

Prednisone

Product NDC
52959-126
11-digit product format
529590126
Labeler code
52959
Product ID
52959-126_65be80e7-696c-4442-a683-38bbb6eddcba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisone
Dosage form
TABLET
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA040256
Marketing category
ANDA
Marketing start
2002-07-12
Marketing end
0000-00-00
Substance
PREDNISONE
Active strength
10 mg/1
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

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
52959-126-002020-01-31C16284748780-19d75b9d0-9799-f424-e053-dadaa90a57cePredniSONE TABLETS, USP 10 mg
52959-126-052020-01-31C16284748780-19d75b9d0-9799-f424-e053-dadaa90a57cePredniSONE TABLETS, USP 10 mg
52959-126-072020-01-31C16284748780-19d75b9d0-9799-f424-e053-dadaa90a57cePredniSONE TABLETS, USP 10 mg
52959-126-102020-01-31C16284748780-19d75b9d0-9799-f424-e053-dadaa90a57cePredniSONE TABLETS, USP 10 mg
52959-126-122020-01-31C16284748780-19d75b9d0-9799-f424-e053-dadaa90a57cePredniSONE TABLETS, USP 10 mg
52959-126-142020-01-31C16284748780-19d75b9d0-9799-f424-e053-dadaa90a57cePredniSONE TABLETS, USP 10 mg
52959-126-152020-01-31C16284748780-19d75b9d0-9799-f424-e053-dadaa90a57cePredniSONE TABLETS, USP 10 mg
52959-126-182020-01-31C16284748780-19d75b9d0-9799-f424-e053-dadaa90a57cePredniSONE TABLETS, USP 10 mg
52959-126-202020-01-31C16284748780-19d75b9d0-9799-f424-e053-dadaa90a57cePredniSONE TABLETS, USP 10 mg
52959-126-212020-01-31C16284748780-19d75b9d0-9799-f424-e053-dadaa90a57cePredniSONE TABLETS, USP 10 mg
52959-126-252020-01-31C16284748780-19d75b9d0-9799-f424-e053-dadaa90a57cePredniSONE TABLETS, USP 10 mg
52959-126-302020-01-31C16284748780-19d75b9d0-9799-f424-e053-dadaa90a57cePredniSONE TABLETS, USP 10 mg
52959-126-372020-01-31C16284748780-19d75b9d0-9799-f424-e053-dadaa90a57cePredniSONE TABLETS, USP 10 mg
52959-126-402020-01-31C16284748780-19d75b9d0-9799-f424-e053-dadaa90a57cePredniSONE TABLETS, USP 10 mg
52959-126-422020-01-31C16284748780-19d75b9d0-9799-f424-e053-dadaa90a57cePredniSONE TABLETS, USP 10 mg
52959-126-442020-01-31C16284748780-19d75b9d0-9799-f424-e053-dadaa90a57cePredniSONE TABLETS, USP 10 mg
52959-126-452020-01-31C16284748780-19d75b9d0-9799-f424-e053-dadaa90a57cePredniSONE TABLETS, USP 10 mg
52959-126-502020-01-31C16284748780-19d75b9d0-9799-f424-e053-dadaa90a57cePredniSONE TABLETS, USP 10 mg
52959-126-602020-01-31C16284748780-19d75b9d0-9799-f424-e053-dadaa90a57cePredniSONE TABLETS, USP 10 mg
52959-126-702020-01-31C16284748780-19d75b9d0-9799-f424-e053-dadaa90a57cePredniSONE TABLETS, USP 10 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-126-00Prednisone100 in 1 BOTTLE, PLASTICTABLET1001
52959-126-05Prednisone5 in 1 BOTTLE, PLASTICTABLET51
52959-126-07Prednisone7 in 1 BOTTLE, PLASTICTABLET71
52959-126-10Prednisone10 in 1 BOTTLE, PLASTICTABLET101
52959-126-12Prednisone12 in 1 BOTTLE, PLASTICTABLET121
52959-126-14Prednisone14 in 1 BOTTLE, PLASTICTABLET141
52959-126-15Prednisone15 in 1 BOTTLE, PLASTICTABLET151
52959-126-18Prednisone18 in 1 BOTTLE, PLASTICTABLET181
52959-126-20Prednisone20 in 1 BOTTLE, PLASTICTABLET201
52959-126-21Prednisone21 in 1 BOTTLE, PLASTICTABLET211
52959-126-25Prednisone25 in 1 BOTTLE, PLASTICTABLET251
52959-126-30Prednisone30 in 1 BOTTLE, PLASTICTABLET301
52959-126-37Prednisone37 in 1 BOTTLE, PLASTICTABLET371
52959-126-40Prednisone40 in 1 BOTTLE, PLASTICTABLET401
52959-126-42Prednisone42 in 1 BOTTLE, PLASTICTABLET421
52959-126-44Prednisone44 in 1 BOTTLE, PLASTICTABLET441
52959-126-45Prednisone45 in 1 BOTTLE, PLASTICTABLET451
52959-126-50Prednisone50 in 1 BOTTLE, PLASTICTABLET501
52959-126-60Prednisone60 in 1 BOTTLE, PLASTICTABLET601
52959-126-70Prednisone70 in 1 BOTTLE, PLASTICTABLET701

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-126-00EA - Each52959-1264d465693-daf2-4753-9c7f-d3e4f5a0e85f12012-07-24
52959-126-05EA - Each52959-126d9a5449c-dd8a-496a-ae34-885450b9077112012-07-24
52959-126-07EA - Each52959-1261093db4e-dc57-49c4-83ea-875a5f3cd26612012-07-24
52959-126-10EA - Each52959-1266d2831fd-9a1c-441f-8434-11c2906bf2f312012-07-24
52959-126-12EA - Each52959-126e47b0d26-40f3-47fd-84f6-707965e8c27812012-07-24
52959-126-15EA - Each52959-126387ec11c-9116-458e-9540-9be644598ec112012-07-24
52959-126-18EA - Each52959-126ae8b07d1-d725-47e2-ba30-370abb130a9f12012-07-24
52959-126-20EA - Each52959-126b2783fa7-fd05-45c4-87a0-ab337ad0e5ce12012-07-24
52959-126-21EA - Each52959-12606112439-a0df-4cf2-ab95-85c0cd7e575c12012-07-24
52959-126-25EA - Each52959-12614071112-beea-4645-a342-6edb9e40a9c512012-07-24
52959-126-30EA - Each52959-1262182ef4b-82b9-4b87-b973-7173176e40c012012-07-24
52959-126-37EA - Each52959-126051f11dd-bffb-4f15-9213-83d809fe34cf12012-07-24
52959-126-40EA - Each52959-126f935c871-a7a6-4557-8905-6488d3de459612012-07-24
52959-126-42EA - Each52959-126e8977569-6b04-404c-bee8-101c6c9944b412012-07-24
52959-126-44EA - Each52959-126a3a52d48-723e-4e61-a8f8-0e5672ad528812012-07-24
52959-126-45EA - Each52959-126f4c413c3-0d40-4ae2-bb52-8d0ff431586512015-10-02
52959-126-50EA - Each52959-1266bbf30bb-1e4e-46f4-9d34-7cf9bb023b9f12012-07-24
52959-126-60EA - Each52959-1262990e913-4b4a-4293-9023-8f32997efb6b12012-07-24
52959-126-70EA - Each52959-12621ed64ce-b7de-40d6-92fa-ce4a7491857112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PREDNISONEACTIVE INGREDIENTVB0R961HZTPREDNISONE TABLET [H.J. HARKINS COMPANY, INC.]1
PREDNISONEACTIVE MOIETYVB0R961HZTPREDNISONE TABLET [H.J. HARKINS COMPANY, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPREDNISONE TABLET [H.J. HARKINS COMPANY, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PREDNISONE TABLET [H.J. HARKINS COMPANY, INC.]1
SILICON DIOXIDE, COLLOIDALINACTIVE INGREDIENTETJ7Z6XBU4PREDNISONE TABLET [H.J. HARKINS COMPANY, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PREDNISONE TABLET [H.J. HARKINS COMPANY, INC.]1
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJPREDNISONE TABLET [H.J. HARKINS COMPANY, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-126PREDNISONE TABLET [H.J. HARKINS COMPANY, INC.]1Legacy NDC, 20 package rows20111118_b44702ca-0f0f-4180-9462-3e5c932c999e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198145predniSONE 10 MG Oral TabletPSNb44702ca-0f0f-4180-9462-3e5c932c999e1
198145prednisone 10 MG Oral TabletSCDb44702ca-0f0f-4180-9462-3e5c932c999e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-126-0052959012600100 in 1 BOTTLE, PLASTICHistorical
52959-126-05529590126055 in 1 BOTTLE, PLASTICHistorical
52959-126-07529590126077 in 1 BOTTLE, PLASTICHistorical
52959-126-105295901261010 in 1 BOTTLE, PLASTICHistorical
52959-126-125295901261212 in 1 BOTTLE, PLASTICHistorical
52959-126-145295901261414 in 1 BOTTLE, PLASTICHistorical
52959-126-155295901261515 in 1 BOTTLE, PLASTICHistorical
52959-126-185295901261818 in 1 BOTTLE, PLASTICHistorical
52959-126-205295901262020 in 1 BOTTLE, PLASTICHistorical
52959-126-215295901262121 in 1 BOTTLE, PLASTICHistorical
52959-126-255295901262525 in 1 BOTTLE, PLASTICHistorical
52959-126-305295901263030 in 1 BOTTLE, PLASTICHistorical
52959-126-375295901263737 in 1 BOTTLE, PLASTICHistorical
52959-126-405295901264040 in 1 BOTTLE, PLASTICHistorical
52959-126-425295901264242 in 1 BOTTLE, PLASTICHistorical
52959-126-445295901264444 in 1 BOTTLE, PLASTICHistorical
52959-126-455295901264545 in 1 BOTTLE, PLASTICHistorical
52959-126-505295901265050 in 1 BOTTLE, PLASTICHistorical
52959-126-605295901266060 in 1 BOTTLE, PLASTICHistorical
52959-126-705295901267070 in 1 BOTTLE, PLASTICHistorical