FDA.reportPublic FDA data

Diethylpropion Hydrochloride

Product NDC
63187-947
11-digit product format
631870947
Labeler code
63187
Product ID
63187-947_0ca25f66-ddce-4617-be6e-69e3d8ad7844
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diethylpropion Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-947-21Diethylpropion Hydrochloride21 in 1 BOTTLE, PLASTICTABLET214
63187-947-30Diethylpropion Hydrochloride30 in 1 BOTTLE, PLASTICTABLET304
63187-947-60Diethylpropion Hydrochloride60 in 1 BOTTLE, PLASTICTABLET604
63187-947-90Diethylpropion Hydrochloride90 in 1 BOTTLE, PLASTICTABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-947-21EA - Each63187-947cc99d813-4935-4120-ac5e-a3fcd43ba49d12018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-947DIETHYLPROPION HYDROCHLORIDE TABLET [PROFICIENT RX LP]4Current NDC, Legacy NDC, 4 package rows20201031_2a2fbc1b-6430-485b-b581-10fbfca0af88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978654diethylpropion HCl 25 MG Oral TabletPSN2a2fbc1b-6430-485b-b581-10fbfca0af884
978654diethylpropion hydrochloride 25 MG Oral TabletSCD2a2fbc1b-6430-485b-b581-10fbfca0af884

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-947-216318709472121 TABLET in 1 BOTTLE, PLASTIC (63187-947-21) 21 tablet2018-01-010000-00-00NoNoCurrent
63187-947-306318709473030 TABLET in 1 BOTTLE, PLASTIC (63187-947-30) 30 tablet2018-01-010000-00-00NoNoCurrent
63187-947-606318709476060 TABLET in 1 BOTTLE, PLASTIC (63187-947-60) 60 tablet2018-01-010000-00-00NoNoCurrent
63187-947-906318709479090 TABLET in 1 BOTTLE, PLASTIC (63187-947-90) 90 tablet2018-01-010000-00-00NoNoCurrent