FDA.reportPublic FDA data

Diethylpropion Hydrochloride

Product NDC
0527-1477
11-digit product format
005271477
Labeler code
0527
Product ID
0527-1477_425fc6fb-0240-4af6-83e4-3c7cb54c50e3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diethylpropion Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Lannett Company, Inc.
Application
ANDA091680
Marketing category
ANDA
Marketing start
2011-10-24
Substance
DIETHYLPROPION HYDROCHLORIDE
Active strength
75 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
Brand name suffix
ER
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIETHYLPROPION HYDROCHLORIDE75 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii19V2PL39NG
Rxcui978668

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
0527-1477-012024-01-30C16284748780-11030e365-35b0-111a-e063-dadaa90a10e2Diethylpropion Hydrochloride Extended Release Tablets, 75 mg CIV Rx only
0527-1477-252024-01-30C16284748780-11030e365-35b0-111a-e063-dadaa90a10e2Diethylpropion Hydrochloride Extended Release Tablets, 75 mg CIV Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0527-1477-01Diethylpropion HydrochlorideER100 in 1 BOTTLETABLET, EXTENDED RELEASE10018
0527-1477-25Diethylpropion HydrochlorideER250 in 1 BOTTLETABLET, EXTENDED RELEASE25018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0527-1477-01EA - Each0527-14779958ad64-0793-4723-8686-b4bee9f16faa12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIETHYLPROPION HYDROCHLORIDEACTIVE INGREDIENT19V2PL39NGDIETHYLPROPION HYDROCHLORIDE ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]12
DIETHYLPROPIONACTIVE MOIETYQ94YYU22B8DIETHYLPROPION HYDROCHLORIDE ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]12
CARBOMER HOMOPOLYMER TYPE AINACTIVE INGREDIENTF68VH75CJCDIETHYLPROPION HYDROCHLORIDE ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]12
HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MM2/S)INACTIVE INGREDIENT6N003M473WDIETHYLPROPION HYDROCHLORIDE ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]12
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIETHYLPROPION HYDROCHLORIDE ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]12
MANNITOLINACTIVE INGREDIENT3OWL53L36ADIETHYLPROPION HYDROCHLORIDE ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]12
POVIDONE K30INACTIVE INGREDIENTU725QWY32XDIETHYLPROPION HYDROCHLORIDE ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]12
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HDIETHYLPROPION HYDROCHLORIDE ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]12
DIETHYLPROPION HYDROCHLORIDEACTIVE INGREDIENT19V2PL39NGDIETHYLPROPION HYDROCHLORIDE ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [LANNETT COMPANY, INC.]10
DIETHYLPROPIONACTIVE MOIETYQ94YYU22B8DIETHYLPROPION HYDROCHLORIDE ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [LANNETT COMPANY, INC.]10
CARBOMER HOMOPOLYMER TYPE AINACTIVE INGREDIENTF68VH75CJCDIETHYLPROPION HYDROCHLORIDE ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [LANNETT COMPANY, INC.]10
HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MM2/S)INACTIVE INGREDIENT6N003M473WDIETHYLPROPION HYDROCHLORIDE ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [LANNETT COMPANY, INC.]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIETHYLPROPION HYDROCHLORIDE ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [LANNETT COMPANY, INC.]10
MANNITOLINACTIVE INGREDIENT3OWL53L36ADIETHYLPROPION HYDROCHLORIDE ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [LANNETT COMPANY, INC.]10
POVIDONE K30INACTIVE INGREDIENTU725QWY32XDIETHYLPROPION HYDROCHLORIDE ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [LANNETT COMPANY, INC.]10
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HDIETHYLPROPION HYDROCHLORIDE ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [LANNETT COMPANY, INC.]10
DIETHYLPROPION HYDROCHLORIDEACTIVE INGREDIENT19V2PL39NGDIETHYLPROPION HYDROCHLORIDE ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS LLC]1
DIETHYLPROPION HYDROCHLORIDEACTIVE INGREDIENT19V2PL39NGDIETHYLPROPION HYDROCHLORIDEER ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
DIETHYLPROPIONACTIVE MOIETYQ94YYU22B8DIETHYLPROPION HYDROCHLORIDE ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS LLC]1
DIETHYLPROPIONACTIVE MOIETYQ94YYU22B8DIETHYLPROPION HYDROCHLORIDEER ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
CARBOMER HOMOPOLYMER TYPE AINACTIVE INGREDIENTF68VH75CJCDIETHYLPROPION HYDROCHLORIDE ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS LLC]1
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENTF68VH75CJCDIETHYLPROPION HYDROCHLORIDEER ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MM2/S)INACTIVE INGREDIENT6N003M473WDIETHYLPROPION HYDROCHLORIDEER ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MM2/S)INACTIVE INGREDIENT6N003M473WDIETHYLPROPION HYDROCHLORIDE ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIETHYLPROPION HYDROCHLORIDEER ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIETHYLPROPION HYDROCHLORIDE ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS LLC]1
MANNITOLINACTIVE INGREDIENT3OWL53L36ADIETHYLPROPION HYDROCHLORIDEER ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
MANNITOLINACTIVE INGREDIENT3OWL53L36ADIETHYLPROPION HYDROCHLORIDE ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS LLC]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XDIETHYLPROPION HYDROCHLORIDEER ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XDIETHYLPROPION HYDROCHLORIDE ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS LLC]1
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HDIETHYLPROPION HYDROCHLORIDEER ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HDIETHYLPROPION HYDROCHLORIDE ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0527-1477DIETHYLPROPION HYDROCHLORIDE ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [LANNETT COMPANY, INC.]18Current NDC, Legacy NDC, 2 package rows20240704_dab53f4f-68d4-4477-a2b6-ad44a956332b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978668diethylpropion HCl 75 MG 24HR Extended Release Oral TabletPSN04f1a804-00f1-48f5-acfa-0ed1a854478429
97866824 HR diethylpropion hydrochloride 75 MG Extended Release Oral TabletSCD04f1a804-00f1-48f5-acfa-0ed1a854478429
978668diethylpropion hydrochloride 75 MG 24 HR Extended Release Oral TabletSY04f1a804-00f1-48f5-acfa-0ed1a854478429
978668diethylpropion HCl 75 MG 24HR Extended Release Oral TabletPSN0d213a24-ebbf-41df-8f32-de44a572829e28
97866824 HR diethylpropion hydrochloride 75 MG Extended Release Oral TabletSCD0d213a24-ebbf-41df-8f32-de44a572829e28
978668diethylpropion hydrochloride 75 MG 24 HR Extended Release Oral TabletSY0d213a24-ebbf-41df-8f32-de44a572829e28
978668diethylpropion HCl 75 MG 24HR Extended Release Oral TabletPSNdab53f4f-68d4-4477-a2b6-ad44a956332b18
97866824 HR diethylpropion hydrochloride 75 MG Extended Release Oral TabletSCDdab53f4f-68d4-4477-a2b6-ad44a956332b18
978668diethylpropion hydrochloride 75 MG 24 HR Extended Release Oral TabletSYdab53f4f-68d4-4477-a2b6-ad44a956332b18
978668diethylpropion HCl 75 MG 24HR Extended Release Oral TabletPSN89306917-a65b-40d4-9c51-d59ac0ad201710
97866824 HR diethylpropion hydrochloride 75 MG Extended Release Oral TabletSCD89306917-a65b-40d4-9c51-d59ac0ad201710
978668diethylpropion hydrochloride 75 MG 24 HR Extended Release Oral TabletSY89306917-a65b-40d4-9c51-d59ac0ad201710
978668diethylpropion HCl 75 MG 24HR Extended Release Oral TabletPSN02478358-f606-4e58-a6eb-fa54bb77b9122
978668diethylpropion HCl 75 MG 24HR Extended Release Oral TabletPSNd44e23db-381a-cfc3-e053-2995a90a13c82
978668diethylpropion HCl 75 MG 24HR Extended Release Oral TabletPSNd6cde8cc-26ae-4087-8eac-b11192749cc52
978668diethylpropion HCl 75 MG 24HR Extended Release Oral TabletPSN15110f70-6602-4e05-a4b5-716a86dcaed52
97866824 HR diethylpropion hydrochloride 75 MG Extended Release Oral TabletSCDd6cde8cc-26ae-4087-8eac-b11192749cc52
97866824 HR diethylpropion hydrochloride 75 MG Extended Release Oral TabletSCD15110f70-6602-4e05-a4b5-716a86dcaed52
97866824 HR diethylpropion hydrochloride 75 MG Extended Release Oral TabletSCD02478358-f606-4e58-a6eb-fa54bb77b9122
97866824 HR diethylpropion hydrochloride 75 MG Extended Release Oral TabletSCDd44e23db-381a-cfc3-e053-2995a90a13c82
978668diethylpropion hydrochloride 75 MG 24 HR Extended Release Oral TabletSYd6cde8cc-26ae-4087-8eac-b11192749cc52
978668diethylpropion hydrochloride 75 MG 24 HR Extended Release Oral TabletSY02478358-f606-4e58-a6eb-fa54bb77b9122
978668diethylpropion hydrochloride 75 MG 24 HR Extended Release Oral TabletSYd44e23db-381a-cfc3-e053-2995a90a13c82
978668diethylpropion hydrochloride 75 MG 24 HR Extended Release Oral TabletSY15110f70-6602-4e05-a4b5-716a86dcaed52
978668diethylpropion HCl 75 MG 24HR Extended Release Oral TabletPSN335265e0-1d5d-31fb-e063-6394a90a2e751
978668diethylpropion HCl 75 MG 24HR Extended Release Oral TabletPSN19cfb2fd-f657-4f97-9494-43b909967cfa1
97866824 HR diethylpropion hydrochloride 75 MG Extended Release Oral TabletSCD335265e0-1d5d-31fb-e063-6394a90a2e751
97866824 HR diethylpropion hydrochloride 75 MG Extended Release Oral TabletSCD19cfb2fd-f657-4f97-9494-43b909967cfa1
978668diethylpropion hydrochloride 75 MG 24 HR Extended Release Oral TabletSY335265e0-1d5d-31fb-e063-6394a90a2e751
978668diethylpropion hydrochloride 75 MG 24 HR Extended Release Oral TabletSY19cfb2fd-f657-4f97-9494-43b909967cfa1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0527-1477-0100527147701100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0527-1477-01) 2011-10-240000-00-00NoNoCurrent
0527-1477-2500527147725250 TABLET, EXTENDED RELEASE in 1 BOTTLE (0527-1477-25) 2011-10-240000-00-00NoNoCurrent