FDA.reportPublic FDA data

PREDNISONE

Product NDC
52959-220
11-digit product format
529590220
Labeler code
52959
Product ID
52959-220_5fb1c200-5919-6699-e053-2a91aa0a5208
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
2017-11-16
Marketing end
0000-00-00
Substance
PREDNISONE
Active strength
5 mg/1
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
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
52959-220-002020-01-31C16284748780-19d75b9d0-13e4-f424-e053-dadaa90a57cePredniSONE TABLETS, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg
52959-220-052020-01-31C16284748780-19d75b9cf-eb85-f424-e053-dadaa90a57ce5fb1c200-5918-6699-e053-2a91aa0a5208
52959-220-062020-01-31C16284748780-19d75b9cf-eb85-f424-e053-dadaa90a57ce5fb1c200-5918-6699-e053-2a91aa0a5208
52959-220-102020-01-31C16284748780-19d75b9d0-13e4-f424-e053-dadaa90a57cePredniSONE TABLETS, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg
52959-220-122020-01-31C16284748780-19d75b9d0-13e4-f424-e053-dadaa90a57cePredniSONE TABLETS, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg
52959-220-202020-01-31C16284748780-19d75b9d0-13e4-f424-e053-dadaa90a57cePredniSONE TABLETS, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg
52959-220-212020-01-31C16284748780-19d75b9d0-13e4-f424-e053-dadaa90a57cePredniSONE TABLETS, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg
52959-220-232020-01-31C16284748780-19d75b9cf-eb85-f424-e053-dadaa90a57ce5fb1c200-5918-6699-e053-2a91aa0a5208
52959-220-302020-01-31C16284748780-19d75b9d0-13e4-f424-e053-dadaa90a57cePredniSONE TABLETS, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg
52959-220-362020-01-31C16284748780-19d75b9d0-13e4-f424-e053-dadaa90a57cePredniSONE TABLETS, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg
52959-220-402020-01-31C16284748780-19d75b9d0-13e4-f424-e053-dadaa90a57cePredniSONE TABLETS, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg
52959-220-602020-01-31C16284748780-19d75b9d0-13e4-f424-e053-dadaa90a57cePredniSONE TABLETS, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg
52959-220-752020-01-31C16284748780-19d75b9d0-13e4-f424-e053-dadaa90a57cePredniSONE TABLETS, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-220-00Prednisone100 in 1 BOTTLE, PLASTICTABLET1001
52959-220-05PREDNISONE5 in 1 BOTTLETABLET51
52959-220-06PREDNISONE6 in 1 BOTTLETABLET61
52959-220-10Prednisone10 in 1 BOTTLE, PLASTICTABLET101
52959-220-12Prednisone12 in 1 BOTTLE, PLASTICTABLET121
52959-220-20Prednisone20 in 1 BOTTLE, PLASTICTABLET201
52959-220-21Prednisone21 in 1 BOTTLE, PLASTICTABLET211
52959-220-23PREDNISONE23 in 1 BOTTLETABLET231
52959-220-30Prednisone30 in 1 BOTTLE, PLASTICTABLET301
52959-220-36Prednisone36 in 1 BOTTLE, PLASTICTABLET361
52959-220-40Prednisone40 in 1 BOTTLE, PLASTICTABLET401
52959-220-60Prednisone60 in 1 BOTTLE, PLASTICTABLET601
52959-220-75Prednisone75 in 1 BOTTLE, PLASTICTABLET751

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-220-00EA - Each52959-220a771ad47-883e-48aa-befd-de7714da828212013-02-13
52959-220-10EA - Each52959-2205fcf4346-49ca-4109-a16e-6c69cbb2124012013-02-13
52959-220-20EA - Each52959-220bd2da0da-8a07-482a-b51b-224381215b7a12013-02-13
52959-220-21EA - Each52959-220a99d206f-c476-43eb-af8c-bcde4917ad2212013-02-13
52959-220-30EA - Each52959-2204460aa67-53b8-45ff-a0e4-0cb12bf56d7912013-02-13
52959-220-36EA - Each52959-2209cb9f0a6-3acc-4a8d-8e22-b88b8901634412013-02-13
52959-220-40EA - Each52959-220e0ca6027-a736-4096-8427-61aa55691cf312013-02-13
52959-220-60EA - Each52959-220f603a5b0-e989-4bb1-ac05-658b730b81fc12013-02-13
52959-220-75EA - Each52959-22004705dd7-ae94-42fa-9303-ea536a3cf38b12013-02-13

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
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PREDNISONE 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
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
52959-220PREDNISONE TABLET [H. J. HARKINS COMPANY INC.]1Legacy NDC, 3 package rows20171207_5fb1c200-5918-6699-e053-2a91aa0a5208.zip
52959-220PREDNISONE TABLET [H.J. HARKINS COMPANY, INC.]1Legacy NDC, 10 package rows20120827_e63df4be-b3d3-4873-92e3-d7fbc84d1dc4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312617predniSONE 5 MG Oral TabletPSN5fb1c200-5918-6699-e053-2a91aa0a52081
312617predniSONE 5 MG Oral TabletPSNe63df4be-b3d3-4873-92e3-d7fbc84d1dc41
312617prednisone 5 MG Oral TabletSCD5fb1c200-5918-6699-e053-2a91aa0a52081
312617prednisone 5 MG Oral TabletSCDe63df4be-b3d3-4873-92e3-d7fbc84d1dc41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-220-0052959022000100 in 1 BOTTLE, PLASTICHistorical
52959-220-05529590220055 in 1 BOTTLEHistorical
52959-220-06529590220066 in 1 BOTTLEHistorical
52959-220-105295902201010 in 1 BOTTLE, PLASTICHistorical
52959-220-125295902201212 in 1 BOTTLE, PLASTICHistorical
52959-220-205295902202020 in 1 BOTTLE, PLASTICHistorical
52959-220-215295902202121 in 1 BOTTLE, PLASTICHistorical
52959-220-235295902202323 in 1 BOTTLEHistorical
52959-220-305295902203030 in 1 BOTTLE, PLASTICHistorical
52959-220-365295902203636 in 1 BOTTLE, PLASTICHistorical
52959-220-405295902204040 in 1 BOTTLE, PLASTICHistorical
52959-220-605295902206060 in 1 BOTTLE, PLASTICHistorical
52959-220-755295902207575 in 1 BOTTLE, PLASTICHistorical