FDA.reportPublic FDA data

DIETHYLPROPION HYDROCHLORIDE

Product NDC
33261-353
11-digit product format
332610353
Labeler code
33261
Product ID
33261-353_9af69fd4-964e-4666-88da-0bc5697e11c1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DIETHYLPROPION HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA201212
Marketing category
ANDA
Marketing start
2010-12-27
Marketing end
0000-00-00
Substance
DIETHYLPROPION HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]
DEA schedule
CIV
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
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
0029c986-f448-4e26-865d-441bd9700d12Product name120201013
a29cb53e-8fe0-4754-9013-e084b50c1c66Product name120170614

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
33261-353-142020-01-31C16284748780-19d75b9cf-f1eb-f424-e053-dadaa90a57ceDiethylpropion HCl USP CIV 25 mg Tablets
33261-353-282020-01-31C16284748780-19d75b9cf-f1eb-f424-e053-dadaa90a57ceDiethylpropion HCl USP CIV 25 mg Tablets
33261-353-302020-01-31C16284748780-19d75b9cf-f1eb-f424-e053-dadaa90a57ceDiethylpropion HCl USP CIV 25 mg Tablets
33261-353-602020-01-31C16284748780-19d75b9cf-f1eb-f424-e053-dadaa90a57ceDiethylpropion HCl USP CIV 25 mg Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-353-14DIETHYLPROPION HYDROCHLORIDE14 in 1 BOTTLE, PLASTICTABLET141
33261-353-28DIETHYLPROPION HYDROCHLORIDE28 in 1 BOTTLE, PLASTICTABLET281
33261-353-30DIETHYLPROPION HYDROCHLORIDE30 in 1 BOTTLE, PLASTICTABLET301
33261-353-60DIETHYLPROPION HYDROCHLORIDE60 in 1 BOTTLE, PLASTICTABLET601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-353-14EA - Each33261-35306960b59-1302-4e9c-94c3-a8d1050bb49812015-10-02
33261-353-28EA - Each33261-35305b3ef1d-8d6e-4368-aa35-9c4219a8214c12015-10-02
33261-353-30EA - Each33261-35387e9c959-84d8-4c0b-9aeb-4add7a16e74012015-10-02
33261-353-60EA - Each33261-3537bdb9f02-5dce-4463-8e8f-15633cd62a3d12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIETHYLPROPION HYDROCHLORIDEACTIVE INGREDIENT19V2PL39NGDIETHYLPROPION HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
DIETHYLPROPIONACTIVE MOIETYQ94YYU22B8DIETHYLPROPION HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKDIETHYLPROPION HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GDIETHYLPROPION HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIETHYLPROPION HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDIETHYLPROPION HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HDIETHYLPROPION HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-353DIETHYLPROPION HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 4 package rows20140106_f9db1711-d3b3-42dc-a5c5-621ab774df20.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978654diethylpropion HCl 25 MG Oral TabletPSNf9db1711-d3b3-42dc-a5c5-621ab774df201
978654diethylpropion hydrochloride 25 MG Oral TabletSCDf9db1711-d3b3-42dc-a5c5-621ab774df201

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-353-143326103531414 in 1 BOTTLE, PLASTICHistorical
33261-353-283326103532828 in 1 BOTTLE, PLASTICHistorical
33261-353-303326103533030 in 1 BOTTLE, PLASTICHistorical
33261-353-603326103536060 in 1 BOTTLE, PLASTICHistorical