FDA.reportPublic FDA data

Prednisone

Product NDC
52959-127
11-digit product format
529590127
Labeler code
52959
Product ID
52959-127_0fbab6d8-b9d9-4e8a-8023-3df614071406
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisone
Dosage form
TABLET
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA040392
Marketing category
ANDA
Marketing start
2003-02-12
Marketing end
0000-00-00
Substance
PREDNISONE
Active strength
20 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
52959-127-072020-01-31C16284748780-19d75b9cf-d589-f424-e053-dadaa90a57cePredniSONE TABLETS, USP 20 mg
52959-127-102020-01-31C16284748780-19d75b9cf-d589-f424-e053-dadaa90a57cePredniSONE TABLETS, USP 20 mg
52959-127-112020-01-31C16284748780-19d75b9cf-d589-f424-e053-dadaa90a57cePredniSONE TABLETS, USP 20 mg
52959-127-122020-01-31C16284748780-19d75b9cf-d589-f424-e053-dadaa90a57cePredniSONE TABLETS, USP 20 mg
52959-127-152020-01-31C16284748780-19d75b9cf-d589-f424-e053-dadaa90a57cePredniSONE TABLETS, USP 20 mg
52959-127-182020-01-31C16284748780-19d75b9cf-d589-f424-e053-dadaa90a57cePredniSONE TABLETS, USP 20 mg
52959-127-202020-01-31C16284748780-19d75b9cf-d589-f424-e053-dadaa90a57cePredniSONE TABLETS, USP 20 mg
52959-127-212020-01-31C16284748780-19d75b9cf-d589-f424-e053-dadaa90a57cePredniSONE TABLETS, USP 20 mg
52959-127-252020-01-31C16284748780-19d75b9cf-d589-f424-e053-dadaa90a57cePredniSONE TABLETS, USP 20 mg
52959-127-302020-01-31C16284748780-19d75b9cf-d589-f424-e053-dadaa90a57cePredniSONE TABLETS, USP 20 mg
52959-127-372020-01-31C16284748780-19d75b9cf-d589-f424-e053-dadaa90a57cePredniSONE TABLETS, USP 20 mg
52959-127-422020-01-31C16284748780-19d75b9cf-d589-f424-e053-dadaa90a57cePredniSONE TABLETS, USP 20 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-127-07Prednisone7 in 1 BOTTLE, PLASTICTABLET72
52959-127-10Prednisone10 in 1 BOTTLE, PLASTICTABLET102
52959-127-11Prednisone11 in 1 BOTTLE, PLASTICTABLET112
52959-127-12Prednisone12 in 1 BOTTLE, PLASTICTABLET122
52959-127-15Prednisone15 in 1 BOTTLE, PLASTICTABLET152
52959-127-18Prednisone18 in 1 BOTTLE, PLASTICTABLET182
52959-127-20Prednisone20 in 1 BOTTLE, PLASTICTABLET202
52959-127-21Prednisone21 in 1 BOTTLE, PLASTICTABLET212
52959-127-25Prednisone25 in 1 BOTTLE, PLASTICTABLET252
52959-127-30Prednisone30 in 1 BOTTLE, PLASTICTABLET302
52959-127-37Prednisone37 in 1 BOTTLE, PLASTICTABLET372
52959-127-42Prednisone42 in 1 BOTTLE, PLASTICTABLET422

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-127-07EA - Each52959-127aca26bbc-86d7-4995-9691-70caf56d272912013-02-13
52959-127-10EA - Each52959-127c1690cb4-64ee-4ab1-8a46-1f12869cb36012013-02-13
52959-127-12EA - Each52959-12744909feb-cf4f-4497-92f4-ccc241f7b0a712013-02-13
52959-127-15EA - Each52959-127ec748118-0241-4e85-82a3-82152d7a99a112013-02-13
52959-127-18EA - Each52959-127d5398feb-b212-4eb6-9af7-5fce0fe451df12013-02-13
52959-127-20EA - Each52959-127805bc277-5455-4f1a-8444-7f21803b47bc12013-02-13
52959-127-21EA - Each52959-127c6e9c332-3295-44f4-93c4-982dc2502e7712013-02-13
52959-127-25EA - Each52959-12755dd82e0-559c-40e7-b8f8-edb44355e80b12013-02-13
52959-127-30EA - Each52959-127a9060540-80a4-4514-a78d-c193dad27e9b12013-02-13
52959-127-37EA - Each52959-1272d185549-01dc-4b54-8bef-6ced8af56e4d12013-02-13
52959-127-42EA - Each52959-127497eb4f9-ecb4-4ac4-a17b-5a6f9849ee7f12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PREDNISONEACTIVE INGREDIENTVB0R961HZTPREDNISONE TABLET [H.J. HARKINS COMPANY, INC.]2
PREDNISONEACTIVE MOIETYVB0R961HZTPREDNISONE TABLET [H.J. HARKINS COMPANY, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPREDNISONE TABLET [H.J. HARKINS COMPANY, INC.]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PREDNISONE TABLET [H.J. HARKINS COMPANY, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPREDNISONE TABLET [H.J. HARKINS COMPANY, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PREDNISONE TABLET [H.J. HARKINS COMPANY, INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PREDNISONE TABLET [H.J. HARKINS COMPANY, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-127PREDNISONE TABLET [H.J. HARKINS COMPANY, INC.]2Legacy NDC, 12 package rows20120830_dfb55c19-be0d-4c9f-8169-c63749da26c2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312615predniSONE 20 MG Oral TabletPSNdfb55c19-be0d-4c9f-8169-c63749da26c22
312615prednisone 20 MG Oral TabletSCDdfb55c19-be0d-4c9f-8169-c63749da26c22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-127-07529590127077 in 1 BOTTLE, PLASTICHistorical
52959-127-105295901271010 in 1 BOTTLE, PLASTICHistorical
52959-127-115295901271111 in 1 BOTTLE, PLASTICHistorical
52959-127-125295901271212 in 1 BOTTLE, PLASTICHistorical
52959-127-155295901271515 in 1 BOTTLE, PLASTICHistorical
52959-127-185295901271818 in 1 BOTTLE, PLASTICHistorical
52959-127-205295901272020 in 1 BOTTLE, PLASTICHistorical
52959-127-215295901272121 in 1 BOTTLE, PLASTICHistorical
52959-127-255295901272525 in 1 BOTTLE, PLASTICHistorical
52959-127-305295901273030 in 1 BOTTLE, PLASTICHistorical
52959-127-375295901273737 in 1 BOTTLE, PLASTICHistorical
52959-127-425295901274242 in 1 BOTTLE, PLASTICHistorical