FDA.reportPublic FDA data

Diethylpropion Hydrochloride

Product NDC
12634-530
11-digit product format
126340530
Labeler code
12634
Product ID
12634-530_46cc3fe9-641c-5efd-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diethylpropion hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Apotheca Inc.
Application
NDA011722
Marketing category
NDA
Marketing start
1959-08-06
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
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
12634-530-002022-07-29C16284748780-1e4f33bdf-a2c1-d8a0-e053-dadaa90a6e4eDiethylpropion HCl USP C-IV Immediate-Release 25 mg Tablets Rx only
12634-530-012022-07-29C16284748780-1e4f33bdf-a2c1-d8a0-e053-dadaa90a6e4eDiethylpropion HCl USP C-IV Immediate-Release 25 mg Tablets Rx only
12634-530-092022-07-29C16284748780-1e4f33bdf-a2c1-d8a0-e053-dadaa90a6e4eDiethylpropion HCl USP C-IV Immediate-Release 25 mg Tablets Rx only
12634-530-122022-07-29C16284748780-1e4f33bdf-a2c1-d8a0-e053-dadaa90a6e4eDiethylpropion HCl USP C-IV Immediate-Release 25 mg Tablets Rx only
12634-530-182022-07-29C16284748780-1e4f33bdf-a2c1-d8a0-e053-dadaa90a6e4eDiethylpropion HCl USP C-IV Immediate-Release 25 mg Tablets Rx only
12634-530-402022-07-29C16284748780-1e4f33bdf-a2c1-d8a0-e053-dadaa90a6e4eDiethylpropion HCl USP C-IV Immediate-Release 25 mg Tablets Rx only
12634-530-422022-07-29C16284748780-1e4f33bdf-a2c1-d8a0-e053-dadaa90a6e4eDiethylpropion HCl USP C-IV Immediate-Release 25 mg Tablets Rx only
12634-530-452022-07-29C16284748780-1e4f33bdf-a2c1-d8a0-e053-dadaa90a6e4eDiethylpropion HCl USP C-IV Immediate-Release 25 mg Tablets Rx only
12634-530-502022-07-29C16284748780-1e4f33bdf-a2c1-d8a0-e053-dadaa90a6e4eDiethylpropion HCl USP C-IV Immediate-Release 25 mg Tablets Rx only
12634-530-522022-07-29C16284748780-1e4f33bdf-a2c1-d8a0-e053-dadaa90a6e4eDiethylpropion HCl USP C-IV Immediate-Release 25 mg Tablets Rx only
12634-530-542022-07-29C16284748780-1e4f33bdf-a2c1-d8a0-e053-dadaa90a6e4eDiethylpropion HCl USP C-IV Immediate-Release 25 mg Tablets Rx only
12634-530-572022-07-29C16284748780-1e4f33bdf-a2c1-d8a0-e053-dadaa90a6e4eDiethylpropion HCl USP C-IV Immediate-Release 25 mg Tablets Rx only
12634-530-592022-07-29C16284748780-1e4f33bdf-a2c1-d8a0-e053-dadaa90a6e4eDiethylpropion HCl USP C-IV Immediate-Release 25 mg Tablets Rx only
12634-530-602022-07-29C16284748780-1e4f33bdf-a2c1-d8a0-e053-dadaa90a6e4eDiethylpropion HCl USP C-IV Immediate-Release 25 mg Tablets Rx only
12634-530-612022-07-29C16284748780-1e4f33bdf-a2c1-d8a0-e053-dadaa90a6e4eDiethylpropion HCl USP C-IV Immediate-Release 25 mg Tablets Rx only
12634-530-632022-07-29C16284748780-1e4f33bdf-a2c1-d8a0-e053-dadaa90a6e4eDiethylpropion HCl USP C-IV Immediate-Release 25 mg Tablets Rx only
12634-530-662022-07-29C16284748780-1e4f33bdf-a2c1-d8a0-e053-dadaa90a6e4eDiethylpropion HCl USP C-IV Immediate-Release 25 mg Tablets Rx only
12634-530-672022-07-29C16284748780-1e4f33bdf-a2c1-d8a0-e053-dadaa90a6e4eDiethylpropion HCl USP C-IV Immediate-Release 25 mg Tablets Rx only
12634-530-692022-07-29C16284748780-1e4f33bdf-a2c1-d8a0-e053-dadaa90a6e4eDiethylpropion HCl USP C-IV Immediate-Release 25 mg Tablets Rx only
12634-530-712022-07-29C16284748780-1e4f33bdf-a2c1-d8a0-e053-dadaa90a6e4eDiethylpropion HCl USP C-IV Immediate-Release 25 mg Tablets Rx only
12634-530-742022-07-29C16284748780-1e4f33bdf-a2c1-d8a0-e053-dadaa90a6e4eDiethylpropion HCl USP C-IV Immediate-Release 25 mg Tablets Rx only
12634-530-782022-07-29C16284748780-1e4f33bdf-a2c1-d8a0-e053-dadaa90a6e4eDiethylpropion HCl USP C-IV Immediate-Release 25 mg Tablets Rx only
12634-530-792022-07-29C16284748780-1e4f33bdf-a2c1-d8a0-e053-dadaa90a6e4eDiethylpropion HCl USP C-IV Immediate-Release 25 mg Tablets Rx only
12634-530-802022-07-29C16284748780-1e4f33bdf-a2c1-d8a0-e053-dadaa90a6e4eDiethylpropion HCl USP C-IV Immediate-Release 25 mg Tablets Rx only
12634-530-812022-07-29C16284748780-1e4f33bdf-a2c1-d8a0-e053-dadaa90a6e4eDiethylpropion HCl USP C-IV Immediate-Release 25 mg Tablets Rx only
12634-530-822022-07-29C16284748780-1e4f33bdf-a2c1-d8a0-e053-dadaa90a6e4eDiethylpropion HCl USP C-IV Immediate-Release 25 mg Tablets Rx only
12634-530-842022-07-29C16284748780-1e4f33bdf-a2c1-d8a0-e053-dadaa90a6e4eDiethylpropion HCl USP C-IV Immediate-Release 25 mg Tablets Rx only
12634-530-852022-07-29C16284748780-1e4f33bdf-a2c1-d8a0-e053-dadaa90a6e4eDiethylpropion HCl USP C-IV Immediate-Release 25 mg Tablets Rx only
12634-530-902022-07-29C16284748780-1e4f33bdf-a2c1-d8a0-e053-dadaa90a6e4eDiethylpropion HCl USP C-IV Immediate-Release 25 mg Tablets Rx only
12634-530-912022-07-29C16284748780-1e4f33bdf-a2c1-d8a0-e053-dadaa90a6e4eDiethylpropion HCl USP C-IV Immediate-Release 25 mg Tablets Rx only
12634-530-922022-07-29C16284748780-1e4f33bdf-a2c1-d8a0-e053-dadaa90a6e4eDiethylpropion HCl USP C-IV Immediate-Release 25 mg Tablets Rx only
12634-530-932022-07-29C16284748780-1e4f33bdf-a2c1-d8a0-e053-dadaa90a6e4eDiethylpropion HCl USP C-IV Immediate-Release 25 mg Tablets Rx only
12634-530-942022-07-29C16284748780-1e4f33bdf-a2c1-d8a0-e053-dadaa90a6e4eDiethylpropion HCl USP C-IV Immediate-Release 25 mg Tablets Rx only
12634-530-952022-07-29C16284748780-1e4f33bdf-a2c1-d8a0-e053-dadaa90a6e4eDiethylpropion HCl USP C-IV Immediate-Release 25 mg Tablets Rx only
12634-530-962022-07-29C16284748780-1e4f33bdf-a2c1-d8a0-e053-dadaa90a6e4eDiethylpropion HCl USP C-IV Immediate-Release 25 mg Tablets Rx only
12634-530-972022-07-29C16284748780-1e4f33bdf-a2c1-d8a0-e053-dadaa90a6e4eDiethylpropion HCl USP C-IV Immediate-Release 25 mg Tablets Rx only
12634-530-982022-07-29C16284748780-1e4f33bdf-a2c1-d8a0-e053-dadaa90a6e4eDiethylpropion HCl USP C-IV Immediate-Release 25 mg Tablets Rx only
12634-530-992022-07-29C16284748780-1e4f33bdf-a2c1-d8a0-e053-dadaa90a6e4eDiethylpropion HCl USP C-IV Immediate-Release 25 mg Tablets Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12634-530-00Diethylpropion Hydrochloride10 in 1 BOTTLETABLET103
12634-530-01Diethylpropion Hydrochloride100 in 1 BOTTLETABLET1003
12634-530-09Diethylpropion Hydrochloride35 in 1 BOTTLETABLET353
12634-530-12Diethylpropion Hydrochloride120 in 1 BOTTLETABLET1203
12634-530-18Diethylpropion Hydrochloride180 in 1 BOTTLETABLET1803
12634-530-40Diethylpropion Hydrochloride40 in 1 BOTTLETABLET403
12634-530-42Diethylpropion Hydrochloride42 in 1 BOTTLETABLET423
12634-530-45Diethylpropion Hydrochloride45 in 1 BOTTLETABLET453
12634-530-50Diethylpropion Hydrochloride50 in 1 BOTTLETABLET503
12634-530-52Diethylpropion Hydrochloride12 in 1 BLISTER PACKTABLET123
12634-530-54Diethylpropion Hydrochloride14 in 1 BLISTER PACKTABLET143
12634-530-57Diethylpropion Hydrochloride20 in 1 BLISTER PACKTABLET203
12634-530-59Diethylpropion Hydrochloride30 in 1 BLISTER PACKTABLET303
12634-530-60Diethylpropion Hydrochloride60 in 1 BOTTLETABLET603
12634-530-61Diethylpropion Hydrochloride10 in 1 BLISTER PACKTABLET103
12634-530-63Diethylpropion Hydrochloride3 in 1 BLISTER PACKTABLET33
12634-530-66Diethylpropion Hydrochloride6 in 1 BLISTER PACKTABLET63
12634-530-67Diethylpropion Hydrochloride7 in 1 BLISTER PACKTABLET73
12634-530-69Diethylpropion Hydrochloride9 in 1 BLISTER PACKTABLET93
12634-530-71Diethylpropion Hydrochloride30 in 1 BOTTLETABLET303
12634-530-74Diethylpropion Hydrochloride24 in 1 BOTTLETABLET243
12634-530-78Diethylpropion Hydrochloride28 in 1 BOTTLETABLET283
12634-530-79Diethylpropion Hydrochloride25 in 1 BOTTLETABLET253
12634-530-80Diethylpropion Hydrochloride20 in 1 BOTTLETABLET203
12634-530-81Diethylpropion Hydrochloride21 in 1 BOTTLETABLET213
12634-530-82Diethylpropion Hydrochloride12 in 1 BOTTLETABLET123
12634-530-84Diethylpropion Hydrochloride14 in 1 BOTTLETABLET143
12634-530-85Diethylpropion Hydrochloride15 in 1 BOTTLETABLET153
12634-530-90Diethylpropion Hydrochloride90 in 1 BOTTLETABLET903
12634-530-91Diethylpropion Hydrochloride1 in 1 BLISTER PACKTABLET13
12634-530-92Diethylpropion Hydrochloride2 in 1 BOTTLETABLET23
12634-530-93Diethylpropion Hydrochloride3 in 1 BOTTLETABLET33
12634-530-94Diethylpropion Hydrochloride4 in 1 BOTTLETABLET43
12634-530-95Diethylpropion Hydrochloride5 in 1 BOTTLETABLET53
12634-530-96Diethylpropion Hydrochloride6 in 1 BOTTLETABLET63
12634-530-97Diethylpropion Hydrochloride7 in 1 BOTTLETABLET73
12634-530-98Diethylpropion Hydrochloride8 in 1 BOTTLETABLET83
12634-530-99Diethylpropion Hydrochloride9 in 1 BOTTLETABLET93

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIETHYLPROPION HYDROCHLORIDEACTIVE INGREDIENT19V2PL39NGDIETHYLPROPION HYDROCHLORIDE TABLET DIETHYLPROPION HYDROCHLORIDE ER TABLET [APOTHECA INC]1
DIETHYLPROPIONACTIVE MOIETYQ94YYU22B8DIETHYLPROPION HYDROCHLORIDE TABLET DIETHYLPROPION HYDROCHLORIDE ER TABLET [APOTHECA INC]1
CARBOMER 934INACTIVE INGREDIENTZ135WT9208DIETHYLPROPION HYDROCHLORIDE TABLET DIETHYLPROPION HYDROCHLORIDE ER TABLET [APOTHECA INC]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GDIETHYLPROPION HYDROCHLORIDE TABLET DIETHYLPROPION HYDROCHLORIDE ER TABLET [APOTHECA INC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIETHYLPROPION HYDROCHLORIDE TABLET DIETHYLPROPION HYDROCHLORIDE ER TABLET [APOTHECA INC]1
MANNITOLINACTIVE INGREDIENT3OWL53L36ADIETHYLPROPION HYDROCHLORIDE TABLET DIETHYLPROPION HYDROCHLORIDE ER TABLET [APOTHECA INC]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EDIETHYLPROPION HYDROCHLORIDE TABLET DIETHYLPROPION HYDROCHLORIDE ER TABLET [APOTHECA INC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDIETHYLPROPION HYDROCHLORIDE TABLET DIETHYLPROPION HYDROCHLORIDE ER TABLET [APOTHECA INC]1
TALCINACTIVE INGREDIENT7SEV7J4R1UDIETHYLPROPION HYDROCHLORIDE TABLET DIETHYLPROPION HYDROCHLORIDE ER TABLET [APOTHECA INC]1
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HDIETHYLPROPION HYDROCHLORIDE TABLET DIETHYLPROPION HYDROCHLORIDE ER TABLET [APOTHECA INC]1
ZINC STEARATEINACTIVE INGREDIENTH92E6QA4FVDIETHYLPROPION HYDROCHLORIDE TABLET DIETHYLPROPION HYDROCHLORIDE ER TABLET [APOTHECA INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12634-530DIETHYLPROPION HYDROCHLORIDE TABLET [APOTHECA INC.]3Legacy NDC, 38 package rows20170124_0971fa2e-d660-48b0-9fbb-96a2db167b92.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978654diethylpropion HCl 25 MG Oral TabletPSN0971fa2e-d660-48b0-9fbb-96a2db167b923
978654diethylpropion hydrochloride 25 MG Oral TabletSCD0971fa2e-d660-48b0-9fbb-96a2db167b923

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
12634-530-001263405300010 TABLET in 1 BOTTLE (12634-530-00) 10 tablet2017-01-230000-00-00NoNoCurrent
12634-530-0112634053001100 TABLET in 1 BOTTLE (12634-530-01) 100 tablet2017-01-230000-00-00NoNoCurrent
12634-530-091263405300935 TABLET in 1 BOTTLE (12634-530-09) 35 tablet2017-01-230000-00-00NoNoCurrent
12634-530-1212634053012120 TABLET in 1 BOTTLE (12634-530-12) 120 tablet2017-01-230000-00-00NoNoCurrent
12634-530-1812634053018180 TABLET in 1 BOTTLE (12634-530-18) 180 tablet2017-01-230000-00-00NoNoCurrent
12634-530-401263405304040 TABLET in 1 BOTTLE (12634-530-40) 40 tablet2017-01-230000-00-00NoNoCurrent
12634-530-421263405304242 TABLET in 1 BOTTLE (12634-530-42) 42 tablet2017-01-230000-00-00NoNoCurrent
12634-530-451263405304545 TABLET in 1 BOTTLE (12634-530-45) 45 tablet2017-01-230000-00-00NoNoCurrent
12634-530-501263405305050 TABLET in 1 BOTTLE (12634-530-50) 50 tablet2017-01-230000-00-00NoNoCurrent
12634-530-521263405305212 TABLET in 1 BLISTER PACK (12634-530-52) 12 tablet2017-01-230000-00-00NoNoCurrent
12634-530-541263405305414 TABLET in 1 BLISTER PACK (12634-530-54) 14 tablet2017-01-230000-00-00NoNoCurrent
12634-530-571263405305720 TABLET in 1 BLISTER PACK (12634-530-57) 20 tablet2017-01-230000-00-00NoNoCurrent
12634-530-591263405305930 TABLET in 1 BLISTER PACK (12634-530-59) 30 tablet2017-01-230000-00-00NoNoCurrent
12634-530-601263405306060 TABLET in 1 BOTTLE (12634-530-60) 60 tablet2017-01-230000-00-00NoNoCurrent
12634-530-611263405306110 TABLET in 1 BLISTER PACK (12634-530-61) 10 tablet2017-01-230000-00-00NoNoCurrent
12634-530-63126340530633 TABLET in 1 BLISTER PACK (12634-530-63) 3 tablet2017-01-230000-00-00NoNoCurrent
12634-530-66126340530666 TABLET in 1 BLISTER PACK (12634-530-66) 6 tablet2017-01-230000-00-00NoNoCurrent
12634-530-67126340530677 TABLET in 1 BLISTER PACK (12634-530-67) 7 tablet2017-01-230000-00-00NoNoCurrent
12634-530-69126340530699 TABLET in 1 BLISTER PACK (12634-530-69) 9 tablet2017-01-230000-00-00NoNoCurrent
12634-530-711263405307130 TABLET in 1 BOTTLE (12634-530-71) 30 tablet2017-01-230000-00-00NoNoCurrent
12634-530-741263405307424 TABLET in 1 BOTTLE (12634-530-74) 24 tablet2017-01-230000-00-00NoNoCurrent
12634-530-781263405307828 TABLET in 1 BOTTLE (12634-530-78) 28 tablet2017-01-230000-00-00NoNoCurrent
12634-530-791263405307925 TABLET in 1 BOTTLE (12634-530-79) 25 tablet2017-01-230000-00-00NoNoCurrent
12634-530-801263405308020 TABLET in 1 BOTTLE (12634-530-80) 20 tablet2017-01-230000-00-00NoNoCurrent
12634-530-811263405308121 TABLET in 1 BOTTLE (12634-530-81) 21 tablet2017-01-230000-00-00NoNoCurrent
12634-530-821263405308212 TABLET in 1 BOTTLE (12634-530-82) 12 tablet2017-01-230000-00-00NoNoCurrent
12634-530-841263405308414 TABLET in 1 BOTTLE (12634-530-84) 14 tablet2017-01-230000-00-00NoNoCurrent
12634-530-851263405308515 TABLET in 1 BOTTLE (12634-530-85) 15 tablet2017-01-230000-00-00NoNoCurrent
12634-530-901263405309090 TABLET in 1 BOTTLE (12634-530-90) 90 tablet2017-01-230000-00-00NoNoCurrent
12634-530-91126340530911 TABLET in 1 BLISTER PACK (12634-530-91) 1 tablet2017-01-230000-00-00NoNoCurrent
12634-530-92126340530922 TABLET in 1 BOTTLE (12634-530-92) 2 tablet2017-01-230000-00-00NoNoCurrent
12634-530-93126340530933 TABLET in 1 BOTTLE (12634-530-93) 3 tablet2017-01-230000-00-00NoNoCurrent
12634-530-94126340530944 TABLET in 1 BOTTLE (12634-530-94) 4 tablet2017-01-230000-00-00NoNoCurrent
12634-530-95126340530955 TABLET in 1 BOTTLE (12634-530-95) 5 tablet2017-01-230000-00-00NoNoCurrent
12634-530-96126340530966 TABLET in 1 BOTTLE (12634-530-96) 6 tablet2017-01-230000-00-00NoNoCurrent
12634-530-97126340530977 TABLET in 1 BOTTLE (12634-530-97) 7 tablet2017-01-230000-00-00NoNoCurrent
12634-530-98126340530988 TABLET in 1 BOTTLE (12634-530-98) 8 tablet2017-01-230000-00-00NoNoCurrent
12634-530-99126340530999 TABLET in 1 BOTTLE (12634-530-99) 9 tablet2017-01-230000-00-00NoNoCurrent