FDA.reportPublic FDA data

Diethylpropion Hydrochloride

Product NDC
0527-1475
11-digit product format
005271475
Labeler code
0527
Product ID
0527-1475_cafa73c7-2476-42ab-b1ac-2217aedd9e04
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diethylpropion Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Lannett Company, Inc.
Application
ANDA200177
Marketing category
ANDA
Marketing start
2011-07-18
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Diethylpropion Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIETHYLPROPION HYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii19V2PL39NG
Rxcui978654

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
0029c986-f448-4e26-865d-441bd9700d12Product name120201013
a29cb53e-8fe0-4754-9013-e084b50c1c66Product name120170614
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0527-1475-012024-01-30C16284748780-11030e365-3bb4-111a-e063-dadaa90a10e2Diethylpropion Hydrochloride Tablets USP, 25 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0527-1475-01Diethylpropion Hydrochloride100 in 1 BOTTLE, PLASTICTABLET10014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0527-1475-01EA - Each0527-14757b1ced33-e44f-4682-ad5b-11e11f0d102312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIETHYLPROPION HYDROCHLORIDEACTIVE INGREDIENT19V2PL39NGDIETHYLPROPION HYDROCHLORIDE TABLET [LANNETT COMPANY, INC.]3
DIETHYLPROPIONACTIVE MOIETYQ94YYU22B8DIETHYLPROPION HYDROCHLORIDE TABLET [LANNETT COMPANY, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIETHYLPROPION HYDROCHLORIDE TABLET [LANNETT COMPANY, INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDIETHYLPROPION HYDROCHLORIDE TABLET [LANNETT COMPANY, INC.]3
MANNITOLINACTIVE INGREDIENT3OWL53L36ADIETHYLPROPION HYDROCHLORIDE TABLET [LANNETT COMPANY, INC.]3
POVIDONEINACTIVE INGREDIENTFZ989GH94EDIETHYLPROPION HYDROCHLORIDE TABLET [LANNETT COMPANY, INC.]3
TALCINACTIVE INGREDIENT7SEV7J4R1UDIETHYLPROPION HYDROCHLORIDE TABLET [LANNETT COMPANY, INC.]3
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HDIETHYLPROPION HYDROCHLORIDE TABLET [LANNETT COMPANY, INC.]3
ZINC STEARATEINACTIVE INGREDIENTH92E6QA4FVDIETHYLPROPION HYDROCHLORIDE TABLET [LANNETT COMPANY, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0527-1475DIETHYLPROPION HYDROCHLORIDE TABLET [LANNETT COMPANY, INC.]14Current NDC, Legacy NDC, 1 package rows20240704_4fdbc049-6497-4ea0-8788-d2b2963328f7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978654diethylpropion HCl 25 MG Oral TabletPSN5777eed8-c63d-49c4-9dd1-9d087906c36819
978654diethylpropion hydrochloride 25 MG Oral TabletSCD5777eed8-c63d-49c4-9dd1-9d087906c36819
978654diethylpropion HCl 25 MG Oral TabletPSN4fdbc049-6497-4ea0-8788-d2b2963328f714
978654diethylpropion hydrochloride 25 MG Oral TabletSCD4fdbc049-6497-4ea0-8788-d2b2963328f714
978654diethylpropion HCl 25 MG Oral TabletPSN7f4eca5b-f850-44fc-88b4-4d9bcdf2ba4410
978654diethylpropion hydrochloride 25 MG Oral TabletSCD7f4eca5b-f850-44fc-88b4-4d9bcdf2ba4410
978654diethylpropion HCl 25 MG Oral TabletPSN2a2fbc1b-6430-485b-b581-10fbfca0af884
978654diethylpropion HCl 25 MG Oral TabletPSN54655904-7ce2-49d5-9acf-81ad9680d2154
978654diethylpropion hydrochloride 25 MG Oral TabletSCD2a2fbc1b-6430-485b-b581-10fbfca0af884
978654diethylpropion hydrochloride 25 MG Oral TabletSCD54655904-7ce2-49d5-9acf-81ad9680d2154
978654diethylpropion HCl 25 MG Oral TabletPSN66b079af-5764-413e-ab00-aa6a9b07d0b62
978654diethylpropion hydrochloride 25 MG Oral TabletSCD66b079af-5764-413e-ab00-aa6a9b07d0b62
978654diethylpropion HCl 25 MG Oral TabletPSN90ffecff-dd4d-4325-b3d9-ba39d36329191
978654diethylpropion hydrochloride 25 MG Oral TabletSCD90ffecff-dd4d-4325-b3d9-ba39d36329191

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0527-1475-0100527147501100 TABLET in 1 BOTTLE, PLASTIC (0527-1475-01) 100 tablet2011-07-180000-00-00NoNoCurrent