FDA.reportPublic FDA data

Prednisone

Product NDC
33261-351
11-digit product format
332610351
Labeler code
33261
Product ID
33261-351_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
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
33261-351-002020-01-31C16284748780-19d75b9d0-d2b5-f424-e053-dadaa90a57cePredniSONE TABLETS, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg
33261-351-102020-01-31C16284748780-19d75b9d0-d2b5-f424-e053-dadaa90a57cePredniSONE TABLETS, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg
33261-351-122020-01-31C16284748780-19d75b9d0-d2b5-f424-e053-dadaa90a57cePredniSONE TABLETS, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg
33261-351-152020-01-31C16284748780-19d75b9d0-d2b5-f424-e053-dadaa90a57cePredniSONE TABLETS, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg
33261-351-202020-01-31C16284748780-19d75b9d0-d2b5-f424-e053-dadaa90a57cePredniSONE TABLETS, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg
33261-351-212020-01-31C16284748780-19d75b9d0-d2b5-f424-e053-dadaa90a57cePredniSONE TABLETS, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg
33261-351-272020-01-31C16284748780-19d75b9d0-d2b5-f424-e053-dadaa90a57cePredniSONE TABLETS, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg
33261-351-302020-01-31C16284748780-19d75b9d0-d2b5-f424-e053-dadaa90a57cePredniSONE TABLETS, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg
33261-351-402020-01-31C16284748780-19d75b9d0-d2b5-f424-e053-dadaa90a57cePredniSONE TABLETS, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg
33261-351-422020-01-31C16284748780-19d75b9d0-d2b5-f424-e053-dadaa90a57cePredniSONE TABLETS, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg
33261-351-482020-01-31C16284748780-19d75b9d0-d2b5-f424-e053-dadaa90a57cePredniSONE TABLETS, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg
33261-351-502020-01-31C16284748780-19d75b9d0-d2b5-f424-e053-dadaa90a57cePredniSONE TABLETS, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg
33261-351-602020-01-31C16284748780-19d75b9d0-d2b5-f424-e053-dadaa90a57cePredniSONE TABLETS, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg
33261-351-902020-01-31C16284748780-19d75b9d0-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
33261-351-00Prednisone100 in 1 BOTTLE, PLASTICTABLET1002
33261-351-10Prednisone10 in 1 BOTTLE, PLASTICTABLET102
33261-351-12Prednisone12 in 1 BOTTLE, PLASTICTABLET122
33261-351-15Prednisone15 in 1 BOTTLE, PLASTICTABLET152
33261-351-20Prednisone20 in 1 BOTTLE, PLASTICTABLET202
33261-351-21Prednisone21 in 1 BOTTLE, PLASTICTABLET212
33261-351-27Prednisone27 in 1 BOTTLE, PLASTICTABLET272
33261-351-30Prednisone30 in 1 BOTTLE, PLASTICTABLET302
33261-351-40Prednisone40 in 1 BOTTLE, PLASTICTABLET402
33261-351-42Prednisone42 in 1 BOTTLE, PLASTICTABLET422
33261-351-48Prednisone48 in 1 BOTTLE, PLASTICTABLET482
33261-351-50Prednisone50 in 1 BOTTLE, PLASTICTABLET502
33261-351-60Prednisone60 in 1 BOTTLE, PLASTICTABLET602
33261-351-90Prednisone90 in 1 BOTTLE, PLASTICTABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-351-00EA - Each33261-351fbbf53f8-f1d8-492e-912d-ba2a2532c40212016-09-02
33261-351-12EA - Each33261-35118e61653-b8a5-4afb-9882-b02cf011bcd612016-09-02
33261-351-15EA - Each33261-351a2a2af95-d7c2-491b-a8b3-eb0824c7030012016-09-02
33261-351-20EA - Each33261-3512d9f6d50-1f1e-4d36-9995-50e53a3956d612015-10-02
33261-351-21EA - Each33261-351d7d0d3dc-2ecb-492c-8f22-d3ee8a57f69112015-10-02
33261-351-30EA - Each33261-3513ab14cc1-a6cf-4f86-baaf-33660ccdc7bc12015-10-02
33261-351-40EA - Each33261-3511a90962b-6a51-4f73-b34f-35d3a9af2e8412015-10-02
33261-351-50EA - Each33261-3515cf0cb53-1c1d-458c-a9d4-18d0a64cdb4712016-09-02
33261-351-60EA - Each33261-351dbcfad6c-db64-46dc-91bb-5c63ad5cb45512015-10-02
33261-351-90EA - Each33261-3515d71179e-a24a-441b-b23d-078353a8167d12016-04-04

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
33261-351PREDNISONE 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
33261-351-0033261035100100 in 1 BOTTLE, PLASTICHistorical
33261-351-103326103511010 in 1 BOTTLE, PLASTICHistorical
33261-351-123326103511212 in 1 BOTTLE, PLASTICHistorical
33261-351-153326103511515 in 1 BOTTLE, PLASTICHistorical
33261-351-203326103512020 in 1 BOTTLE, PLASTICHistorical
33261-351-213326103512121 in 1 BOTTLE, PLASTICHistorical
33261-351-273326103512727 in 1 BOTTLE, PLASTICHistorical
33261-351-303326103513030 in 1 BOTTLE, PLASTICHistorical
33261-351-403326103514040 in 1 BOTTLE, PLASTICHistorical
33261-351-423326103514242 in 1 BOTTLE, PLASTICHistorical
33261-351-483326103514848 in 1 BOTTLE, PLASTICHistorical
33261-351-503326103515050 in 1 BOTTLE, PLASTICHistorical
33261-351-603326103516060 in 1 BOTTLE, PLASTICHistorical
33261-351-903326103519090 in 1 BOTTLE, PLASTICHistorical