FDA.reportPublic FDA data

DIETHYLPROPION HYDROCHLORIDE

Product NDC
43063-348
11-digit product format
430630348
Labeler code
43063
Product ID
43063-348_41379e71-36e8-db5a-e063-6394a90a63ae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DIETHYLPROPION HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA201212
Marketing category
ANDA
Marketing start
2010-12-27
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
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
0029c986-f448-4e26-865d-441bd9700d12Product name120201013
a29cb53e-8fe0-4754-9013-e084b50c1c66Product name120170614

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43063-348-01DIETHYLPROPION HYDROCHLORIDE100 in 1 BOTTLE, PLASTICTABLET10019
43063-348-07DIETHYLPROPION HYDROCHLORIDE7 in 1 BOTTLE, PLASTICTABLET719
43063-348-14DIETHYLPROPION HYDROCHLORIDE14 in 1 BOTTLE, PLASTICTABLET1419
43063-348-21DIETHYLPROPION HYDROCHLORIDE21 in 1 BOTTLE, PLASTICTABLET2119
43063-348-28DIETHYLPROPION HYDROCHLORIDE28 in 1 BOTTLE, PLASTICTABLET2819
43063-348-30DIETHYLPROPION HYDROCHLORIDE30 in 1 BOTTLE, PLASTICTABLET3019
43063-348-56DIETHYLPROPION HYDROCHLORIDE56 in 1 BOTTLE, PLASTICTABLET5619
43063-348-60DIETHYLPROPION HYDROCHLORIDE60 in 1 BOTTLE, PLASTICTABLET6019
43063-348-90DIETHYLPROPION HYDROCHLORIDE90 in 1 BOTTLE, PLASTICTABLET9019
43063-348-93DIETHYLPROPION HYDROCHLORIDE180 in 1 BOTTLE, PLASTICTABLET18019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-348-01EA - Each43063-348fc029aee-aa43-477d-985f-935307b73a4212012-07-24
43063-348-07EA - Each43063-3489c78bb8b-c2e2-4dee-96bb-022a3467291e12012-07-24
43063-348-14EA - Each43063-3483b53a422-9778-475e-b963-a080179ae5a312012-07-24
43063-348-21EA - Each43063-348e0c0d6b4-085e-4e02-9cef-1972f056a9d812012-07-24
43063-348-28EA - Each43063-34870a3f6dd-3e76-4460-b2ef-c51e2af69adc12012-07-24
43063-348-30EA - Each43063-348936242e4-e863-4b2d-bcb3-d1e7a1b2ebdc12012-07-24
43063-348-56EA - Each43063-348e224bd1e-0fce-4ff1-be54-0b53ada66a6312012-07-24
43063-348-60EA - Each43063-348f883b9f8-b277-4e3a-abab-34a35ce8333212012-07-24
43063-348-90EA - Each43063-348675bb5fe-1a48-4b18-975b-c3f3384da7a012012-07-24
43063-348-93EA - Each43063-3487750d5e6-9a35-4f17-b3ff-b0a180a0599f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIETHYLPROPION HYDROCHLORIDEACTIVE INGREDIENT19V2PL39NGDIETHYLPROPION HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]6
DIETHYLPROPIONACTIVE MOIETYQ94YYU22B8DIETHYLPROPION HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]6
CROSPOVIDONEINACTIVE INGREDIENT68401960MKDIETHYLPROPION HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]6
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GDIETHYLPROPION HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIETHYLPROPION HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]6
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDIETHYLPROPION HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]6
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HDIETHYLPROPION HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-348DIETHYLPROPION HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]18Current NDC, Legacy NDC, 10 package rows20240809_ad0c3dc9-ae13-4853-bc8c-a66e2a69cc10.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978654diethylpropion HCl 25 MG Oral TabletPSNad0c3dc9-ae13-4853-bc8c-a66e2a69cc1019
978654diethylpropion hydrochloride 25 MG Oral TabletSCDad0c3dc9-ae13-4853-bc8c-a66e2a69cc1019

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-348-0143063034801100 TABLET in 1 BOTTLE, PLASTIC (43063-348-01) 100 tablet2012-03-070000-00-00NoNoCurrent
43063-348-07430630348077 TABLET in 1 BOTTLE, PLASTIC (43063-348-07) 7 tablet2012-03-070000-00-00NoNoCurrent
43063-348-144306303481414 TABLET in 1 BOTTLE, PLASTIC (43063-348-14) 14 tablet2012-03-070000-00-00NoNoCurrent
43063-348-214306303482121 TABLET in 1 BOTTLE, PLASTIC (43063-348-21) 21 tablet2012-03-070000-00-00NoNoCurrent
43063-348-284306303482828 TABLET in 1 BOTTLE, PLASTIC (43063-348-28) 28 tablet2012-03-070000-00-00NoNoCurrent
43063-348-304306303483030 TABLET in 1 BOTTLE, PLASTIC (43063-348-30) 30 tablet2012-03-070000-00-00NoNoCurrent
43063-348-564306303485656 TABLET in 1 BOTTLE, PLASTIC (43063-348-56) 56 tablet2012-03-070000-00-00NoNoCurrent
43063-348-604306303486060 TABLET in 1 BOTTLE, PLASTIC (43063-348-60) 60 tablet2012-03-070000-00-00NoNoCurrent
43063-348-904306303489090 TABLET in 1 BOTTLE, PLASTIC (43063-348-90) 90 tablet2012-03-070000-00-00NoNoCurrent
43063-348-9343063034893180 TABLET in 1 BOTTLE, PLASTIC (43063-348-93) 180 tablet2012-03-070000-00-00NoNoCurrent