FDA.reportPublic FDA data

Prednisone

Product NDC
33261-352
11-digit product format
332610352
Labeler code
33261
Product ID
33261-352_3c78a73d-80ef-4a71-8aeb-a101196947e6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisone
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
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
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
33261-352-002020-01-31C16284748780-19d75b9d0-d2b5-f424-e053-dadaa90a57cePredniSONE TABLETS, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg
33261-352-102020-01-31C16284748780-19d75b9d0-d2b5-f424-e053-dadaa90a57cePredniSONE TABLETS, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg
33261-352-122020-01-31C16284748780-19d75b9d0-d2b5-f424-e053-dadaa90a57cePredniSONE TABLETS, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg
33261-352-152020-01-31C16284748780-19d75b9d0-d2b5-f424-e053-dadaa90a57cePredniSONE TABLETS, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg
33261-352-202020-01-31C16284748780-19d75b9d0-d2b5-f424-e053-dadaa90a57cePredniSONE TABLETS, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg
33261-352-212020-01-31C16284748780-19d75b9d0-d2b5-f424-e053-dadaa90a57cePredniSONE TABLETS, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg
33261-352-272020-01-31C16284748780-19d75b9d0-d2b5-f424-e053-dadaa90a57cePredniSONE TABLETS, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg
33261-352-302020-01-31C16284748780-19d75b9d0-d2b5-f424-e053-dadaa90a57cePredniSONE TABLETS, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg
33261-352-402020-01-31C16284748780-19d75b9d0-d2b5-f424-e053-dadaa90a57cePredniSONE TABLETS, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg
33261-352-422020-01-31C16284748780-19d75b9d0-d2b5-f424-e053-dadaa90a57cePredniSONE TABLETS, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg
33261-352-482020-01-31C16284748780-19d75b9d0-d2b5-f424-e053-dadaa90a57cePredniSONE TABLETS, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg
33261-352-502020-01-31C16284748780-19d75b9d0-d2b5-f424-e053-dadaa90a57cePredniSONE TABLETS, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg
33261-352-602020-01-31C16284748780-19d75b9d0-d2b5-f424-e053-dadaa90a57cePredniSONE TABLETS, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg
33261-352-902020-01-31C16284748780-19d75b9d0-d2b5-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
33261-352-00Prednisone100 in 1 BOTTLE, PLASTICTABLET1002
33261-352-10Prednisone10 in 1 BOTTLE, PLASTICTABLET102
33261-352-12Prednisone12 in 1 BOTTLE, PLASTICTABLET122
33261-352-15Prednisone15 in 1 BOTTLE, PLASTICTABLET152
33261-352-20Prednisone20 in 1 BOTTLE, PLASTICTABLET202
33261-352-21Prednisone21 in 1 BOTTLE, PLASTICTABLET212
33261-352-27Prednisone27 in 1 BOTTLE, PLASTICTABLET272
33261-352-30Prednisone30 in 1 BOTTLE, PLASTICTABLET302
33261-352-40Prednisone40 in 1 BOTTLE, PLASTICTABLET402
33261-352-42Prednisone42 in 1 BOTTLE, PLASTICTABLET422
33261-352-48Prednisone48 in 1 BOTTLE, PLASTICTABLET482
33261-352-50Prednisone50 in 1 BOTTLE, PLASTICTABLET502
33261-352-60Prednisone60 in 1 BOTTLE, PLASTICTABLET602
33261-352-90Prednisone90 in 1 BOTTLE, PLASTICTABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-352-10EA - Each33261-352eb9b7902-8452-4c5f-9075-e945ae706ec312016-09-02
33261-352-40EA - Each33261-3529e8cebce-73bf-4d2c-bce1-471be752dd7712016-09-02
33261-352-42EA - Each33261-3522d91ada1-4904-43cb-bc12-448c4c57ba2e12016-09-02
33261-352-48EA - Each33261-3528e19931c-a23b-4682-9385-d2321a3aaf8712015-10-02
33261-352-50EA - Each33261-3525f1da712-0f42-493d-bd2c-eb8d9b8504bb12016-09-02
33261-352-60EA - Each33261-352833676d1-b05c-4f79-8953-e3231359c11c12015-10-02
33261-352-90EA - Each33261-3529355a84a-fce9-497c-950d-e7e070e00a5f12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PREDNISONEACTIVE INGREDIENTVB0R961HZTPREDNISONE TABLET [AIDAREX PHARMACEUTICALS LLC]2
PREDNISONEACTIVE MOIETYVB0R961HZTPREDNISONE TABLET [AIDAREX PHARMACEUTICALS LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPREDNISONE TABLET [AIDAREX PHARMACEUTICALS LLC]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PREDNISONE TABLET [AIDAREX PHARMACEUTICALS LLC]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPREDNISONE TABLET [AIDAREX PHARMACEUTICALS LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PREDNISONE TABLET [AIDAREX PHARMACEUTICALS LLC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PREDNISONE TABLET [AIDAREX PHARMACEUTICALS LLC]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PREDNISONE TABLET [AIDAREX PHARMACEUTICALS LLC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPREDNISONE TABLET [AIDAREX PHARMACEUTICALS LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-352PREDNISONE TABLET [AIDAREX PHARMACEUTICALS LLC]2Legacy NDC, 14 package rows20140402_3d2eb1e3-fc2b-4820-abc6-cae1228df4c2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198145predniSONE 10 MG Oral TabletPSN3d2eb1e3-fc2b-4820-abc6-cae1228df4c22
312615predniSONE 20 MG Oral TabletPSN3d2eb1e3-fc2b-4820-abc6-cae1228df4c22
312617predniSONE 5 MG Oral TabletPSN3d2eb1e3-fc2b-4820-abc6-cae1228df4c22
198145prednisone 10 MG Oral TabletSCD3d2eb1e3-fc2b-4820-abc6-cae1228df4c22
312615prednisone 20 MG Oral TabletSCD3d2eb1e3-fc2b-4820-abc6-cae1228df4c22
312617prednisone 5 MG Oral TabletSCD3d2eb1e3-fc2b-4820-abc6-cae1228df4c22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-352-0033261035200100 in 1 BOTTLE, PLASTICHistorical
33261-352-103326103521010 in 1 BOTTLE, PLASTICHistorical
33261-352-123326103521212 in 1 BOTTLE, PLASTICHistorical
33261-352-153326103521515 in 1 BOTTLE, PLASTICHistorical
33261-352-203326103522020 in 1 BOTTLE, PLASTICHistorical
33261-352-213326103522121 in 1 BOTTLE, PLASTICHistorical
33261-352-273326103522727 in 1 BOTTLE, PLASTICHistorical
33261-352-303326103523030 in 1 BOTTLE, PLASTICHistorical
33261-352-403326103524040 in 1 BOTTLE, PLASTICHistorical
33261-352-423326103524242 in 1 BOTTLE, PLASTICHistorical
33261-352-483326103524848 in 1 BOTTLE, PLASTICHistorical
33261-352-503326103525050 in 1 BOTTLE, PLASTICHistorical
33261-352-603326103526060 in 1 BOTTLE, PLASTICHistorical
33261-352-903326103529090 in 1 BOTTLE, PLASTICHistorical