FDA.reportPublic FDA data

Prednisone

Product NDC
63629-1605
11-digit product format
636291605
Labeler code
63629
Product ID
63629-1605_aeb416b3-5b23-47cc-9c0e-2aae45798f94
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisone
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA040256
Marketing category
ANDA
Marketing start
2002-07-12
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
Rxcui312617

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
63629-1605-02022-02-15C16284748780-19d75b9d0-da11-f424-e053-dadaa90a57cePredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
63629-1605-12022-02-15C16284748780-19d75b9d0-da11-f424-e053-dadaa90a57cePredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
63629-1605-22022-02-15C16284748780-19d75b9d0-da11-f424-e053-dadaa90a57cePredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
63629-1605-32022-02-15C16284748780-19d75b9d0-da11-f424-e053-dadaa90a57cePredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
63629-1605-42022-02-15C16284748780-19d75b9d0-da11-f424-e053-dadaa90a57cePredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
63629-1605-52022-02-15C16284748780-19d75b9d0-da11-f424-e053-dadaa90a57cePredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
63629-1605-62022-02-15C16284748780-19d75b9d0-da11-f424-e053-dadaa90a57cePredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
63629-1605-72022-02-15C16284748780-19d75b9d0-da11-f424-e053-dadaa90a57cePredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
63629-1605-82022-02-15C16284748780-19d75b9d0-da11-f424-e053-dadaa90a57cePredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
63629-1605-92022-02-15C16284748780-19d75b9d0-da11-f424-e053-dadaa90a57cePredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
63629-1605-02020-01-31C16284748780-19d75b9d0-da11-f424-e053-dadaa90a57cePredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
63629-1605-12020-01-31C16284748780-19d75b9d0-da11-f424-e053-dadaa90a57cePredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
63629-1605-22020-01-31C16284748780-19d75b9d0-da11-f424-e053-dadaa90a57cePredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
63629-1605-32020-01-31C16284748780-19d75b9d0-da11-f424-e053-dadaa90a57cePredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
63629-1605-42020-01-31C16284748780-19d75b9d0-da11-f424-e053-dadaa90a57cePredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
63629-1605-52020-01-31C16284748780-19d75b9d0-da11-f424-e053-dadaa90a57cePredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
63629-1605-62020-01-31C16284748780-19d75b9d0-da11-f424-e053-dadaa90a57cePredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
63629-1605-72020-01-31C16284748780-19d75b9d0-da11-f424-e053-dadaa90a57cePredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
63629-1605-82020-01-31C16284748780-19d75b9d0-da11-f424-e053-dadaa90a57cePredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
63629-1605-92020-01-31C16284748780-19d75b9d0-da11-f424-e053-dadaa90a57cePredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-1605-0Prednisone42 in 1 BOTTLETABLET429
63629-1605-1Prednisone30 in 1 BOTTLETABLET309
63629-1605-2Prednisone78 in 1 BOTTLETABLET789
63629-1605-3Prednisone36 in 1 BOTTLETABLET369
63629-1605-4Prednisone21 in 1 BOTTLETABLET219
63629-1605-5Prednisone15 in 1 BOTTLETABLET159
63629-1605-6Prednisone100 in 1 BOTTLETABLET1009
63629-1605-7Prednisone20 in 1 BOTTLETABLET209
63629-1605-8Prednisone10 in 1 BOTTLETABLET109
63629-1605-9Prednisone90 in 1 BOTTLETABLET909

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1605-0EA - Each63629-16053473df04-1e9e-4b27-ac9d-30719d1205b912015-02-02
63629-1605-1EA - Each63629-1605023c150e-a42b-44bc-9551-c5f76c65cd5012012-07-24
63629-1605-2EA - Each63629-16053d748d1b-8fad-4916-8165-1171455061d712012-07-24
63629-1605-3EA - Each63629-16059179d126-7d0e-4a7e-a095-b06f54b21d2312012-07-24
63629-1605-4EA - Each63629-1605ffc98649-056d-4516-ae0e-e710b4a667dd12012-07-24
63629-1605-5EA - Each63629-16058cecedfb-b099-4b73-8428-15a34701d14b12012-07-24
63629-1605-6EA - Each63629-1605fdcc48ec-b4bf-49c0-b159-73593b49512312012-07-24
63629-1605-7EA - Each63629-1605da1ba240-b13b-43e7-aea6-fc9cfd426aaf12012-07-24
63629-1605-8EA - Each63629-1605e9beccef-cde7-4d3c-bba1-fb30413a6b9a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PREDNISONEACTIVE INGREDIENTVB0R961HZTPREDNISONE TABLET [BRYANT RANCH PREPACK]2
PREDNISONEACTIVE MOIETYVB0R961HZTPREDNISONE TABLET [BRYANT RANCH PREPACK]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPREDNISONE TABLET [BRYANT RANCH PREPACK]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PREDNISONE TABLET [BRYANT RANCH PREPACK]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PREDNISONE TABLET [BRYANT RANCH PREPACK]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PREDNISONE TABLET [BRYANT RANCH PREPACK]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPREDNISONE TABLET [BRYANT RANCH PREPACK]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-1605PREDNISONE TABLET [BRYANT RANCH PREPACK]9Current NDC, Legacy NDC, 10 package rows20241017_290a91e5-22ae-4d62-ab34-39a3117002e2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312617predniSONE 5 MG Oral TabletPSN290a91e5-22ae-4d62-ab34-39a3117002e29
312617prednisone 5 MG Oral TabletSCD290a91e5-22ae-4d62-ab34-39a3117002e29

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-1605-06362916050042 TABLET in 1 BOTTLE (63629-1605-0) 42 tablet2010-06-080000-00-00NoNoCurrent
63629-1605-16362916050130 TABLET in 1 BOTTLE (63629-1605-1) 30 tablet2004-12-070000-00-00NoNoCurrent
63629-1605-26362916050278 TABLET in 1 BOTTLE (63629-1605-2) 78 tablet2005-03-180000-00-00NoNoCurrent
63629-1605-36362916050336 TABLET in 1 BOTTLE (63629-1605-3) 36 tablet2010-03-120000-00-00NoNoCurrent
63629-1605-46362916050421 TABLET in 1 BOTTLE (63629-1605-4) 21 tablet2005-01-100000-00-00NoNoCurrent
63629-1605-56362916050515 TABLET in 1 BOTTLE (63629-1605-5) 15 tablet2005-02-110000-00-00NoNoCurrent
63629-1605-663629160506100 TABLET in 1 BOTTLE (63629-1605-6) 100 tablet2008-09-150000-00-00NoNoCurrent
63629-1605-76362916050720 TABLET in 1 BOTTLE (63629-1605-7) 20 tablet2009-06-150000-00-00NoNoCurrent
63629-1605-86362916050810 TABLET in 1 BOTTLE (63629-1605-8) 10 tablet2010-01-180000-00-00NoNoCurrent
63629-1605-96362916050990 TABLET in 1 BOTTLE (63629-1605-9) 90 tablet2010-04-200000-00-00NoNoCurrent