FDA.reportPublic FDA data

Prednisone

Product NDC
33261-129
11-digit product format
332610129
Labeler code
33261
Product ID
33261-129_3c78a73d-80ef-4a71-8aeb-a101196947e6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisone
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
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
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
33261-129-002020-01-31C16284748780-19d75b9d0-d2b5-f424-e053-dadaa90a57cePredniSONE TABLETS, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg
33261-129-102020-01-31C16284748780-19d75b9d0-d2b5-f424-e053-dadaa90a57cePredniSONE TABLETS, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg
33261-129-122020-01-31C16284748780-19d75b9d0-d2b5-f424-e053-dadaa90a57cePredniSONE TABLETS, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg
33261-129-152020-01-31C16284748780-19d75b9d0-d2b5-f424-e053-dadaa90a57cePredniSONE TABLETS, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg
33261-129-202020-01-31C16284748780-19d75b9d0-d2b5-f424-e053-dadaa90a57cePredniSONE TABLETS, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg
33261-129-212020-01-31C16284748780-19d75b9d0-d2b5-f424-e053-dadaa90a57cePredniSONE TABLETS, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg
33261-129-272020-01-31C16284748780-19d75b9d0-d2b5-f424-e053-dadaa90a57cePredniSONE TABLETS, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg
33261-129-302020-01-31C16284748780-19d75b9d0-d2b5-f424-e053-dadaa90a57cePredniSONE TABLETS, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg
33261-129-402020-01-31C16284748780-19d75b9d0-d2b5-f424-e053-dadaa90a57cePredniSONE TABLETS, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg
33261-129-422020-01-31C16284748780-19d75b9d0-d2b5-f424-e053-dadaa90a57cePredniSONE TABLETS, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg
33261-129-482020-01-31C16284748780-19d75b9d0-d2b5-f424-e053-dadaa90a57cePredniSONE TABLETS, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg
33261-129-502020-01-31C16284748780-19d75b9d0-d2b5-f424-e053-dadaa90a57cePredniSONE TABLETS, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg
33261-129-602020-01-31C16284748780-19d75b9d0-d2b5-f424-e053-dadaa90a57cePredniSONE TABLETS, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg
33261-129-902020-01-31C16284748780-19d75b9d0-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
33261-129-00Prednisone100 in 1 BOTTLE, PLASTICTABLET1002
33261-129-10Prednisone10 in 1 BOTTLE, PLASTICTABLET102
33261-129-12Prednisone12 in 1 BOTTLE, PLASTICTABLET122
33261-129-15Prednisone15 in 1 BOTTLE, PLASTICTABLET152
33261-129-20Prednisone20 in 1 BOTTLE, PLASTICTABLET202
33261-129-21Prednisone21 in 1 BOTTLE, PLASTICTABLET212
33261-129-27Prednisone27 in 1 BOTTLE, PLASTICTABLET272
33261-129-30Prednisone30 in 1 BOTTLE, PLASTICTABLET302
33261-129-40Prednisone40 in 1 BOTTLE, PLASTICTABLET402
33261-129-42Prednisone42 in 1 BOTTLE, PLASTICTABLET422
33261-129-48Prednisone48 in 1 BOTTLE, PLASTICTABLET482
33261-129-50Prednisone50 in 1 BOTTLE, PLASTICTABLET502
33261-129-60Prednisone60 in 1 BOTTLE, PLASTICTABLET602
33261-129-90Prednisone90 in 1 BOTTLE, PLASTICTABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-129-10EA - Each33261-12949dc9a16-5a47-4d39-b0dd-7242f448c6db12015-10-02
33261-129-12EA - Each33261-12925e20e05-fedc-4496-b3f8-f01262ca175d12015-10-02
33261-129-15EA - Each33261-129736d7406-38f3-4af8-af86-d1466151332d12016-09-02
33261-129-20EA - Each33261-12914c3a6c5-1e27-4965-b61d-273a219d2dc712015-10-02
33261-129-21EA - Each33261-129af66c021-3111-46ce-a850-84d9fc5db5ae12015-10-02
33261-129-30EA - Each33261-129e58f4e65-fb85-4413-92a1-e8abc1336c7d12015-10-02
33261-129-60EA - Each33261-129882945c3-b781-482b-9d8e-1f5a4903b9f712015-10-02
33261-129-90EA - Each33261-129a5e68a6c-e2f8-4c2e-84c8-d18b0ab7b20412015-10-02

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
33261-129PREDNISONE 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
33261-129-0033261012900100 in 1 BOTTLE, PLASTICHistorical
33261-129-103326101291010 in 1 BOTTLE, PLASTICHistorical
33261-129-123326101291212 in 1 BOTTLE, PLASTICHistorical
33261-129-153326101291515 in 1 BOTTLE, PLASTICHistorical
33261-129-203326101292020 in 1 BOTTLE, PLASTICHistorical
33261-129-213326101292121 in 1 BOTTLE, PLASTICHistorical
33261-129-273326101292727 in 1 BOTTLE, PLASTICHistorical
33261-129-303326101293030 in 1 BOTTLE, PLASTICHistorical
33261-129-403326101294040 in 1 BOTTLE, PLASTICHistorical
33261-129-423326101294242 in 1 BOTTLE, PLASTICHistorical
33261-129-483326101294848 in 1 BOTTLE, PLASTICHistorical
33261-129-503326101295050 in 1 BOTTLE, PLASTICHistorical
33261-129-603326101296060 in 1 BOTTLE, PLASTICHistorical
33261-129-903326101299090 in 1 BOTTLE, PLASTICHistorical