FDA.reportPublic FDA data

Diethylpropion Hydrochloride

Product NDC
50090-0120
11-digit product format
500900120
Labeler code
50090
Product ID
50090-0120_13ef5b9d-dc03-4d36-9219-861ff7acffd8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diethylpropion Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
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
2027-12-31

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
50090-0120-02023-02-07C16284748780-1f386c649-b474-0266-e053-dadaa90a7c1aDiethylpropion Hydrochloride Extended Release Tablets, 75 mg CIV Rx only
50090-0120-02023-02-07C16284748780-1f386c649-b474-0266-e053-dadaa90a7c1aDiethylpropion Hydrochloride Extended Release Tablets, 75 mg CIV Rx only
50090-0120-12023-02-07C16284748780-1f386c649-b474-0266-e053-dadaa90a7c1aDiethylpropion Hydrochloride Extended Release Tablets, 75 mg CIV Rx only
50090-0120-12023-02-07C16284748780-1f386c649-b474-0266-e053-dadaa90a7c1aDiethylpropion Hydrochloride Extended Release Tablets, 75 mg CIV Rx only
50090-0120-42023-02-07C16284748780-1f386c649-b474-0266-e053-dadaa90a7c1aDiethylpropion Hydrochloride Extended Release Tablets, 75 mg CIV Rx only
50090-0120-42023-02-07C16284748780-1f386c649-b474-0266-e053-dadaa90a7c1aDiethylpropion Hydrochloride Extended Release Tablets, 75 mg CIV Rx only
50090-0120-52023-02-07C16284748780-1f386c649-b474-0266-e053-dadaa90a7c1aDiethylpropion Hydrochloride Extended Release Tablets, 75 mg CIV Rx only
50090-0120-52023-02-07C16284748780-1f386c649-b474-0266-e053-dadaa90a7c1aDiethylpropion Hydrochloride Extended Release Tablets, 75 mg CIV Rx only
50090-0120-02023-01-30C16284748780-1f386c649-b474-0266-e053-dadaa90a7c1aDiethylpropion Hydrochloride Extended Release Tablets, 75 mg CIV Rx only
50090-0120-02023-01-30C16284748780-1f386c649-b474-0266-e053-dadaa90a7c1aDiethylpropion Hydrochloride Extended Release Tablets, 75 mg CIV Rx only
50090-0120-12023-01-30C16284748780-1f386c649-b474-0266-e053-dadaa90a7c1aDiethylpropion Hydrochloride Extended Release Tablets, 75 mg CIV Rx only
50090-0120-12023-01-30C16284748780-1f386c649-b474-0266-e053-dadaa90a7c1aDiethylpropion Hydrochloride Extended Release Tablets, 75 mg CIV Rx only
50090-0120-42023-01-30C16284748780-1f386c649-b474-0266-e053-dadaa90a7c1aDiethylpropion Hydrochloride Extended Release Tablets, 75 mg CIV Rx only
50090-0120-42023-01-30C16284748780-1f386c649-b474-0266-e053-dadaa90a7c1aDiethylpropion Hydrochloride Extended Release Tablets, 75 mg CIV Rx only
50090-0120-52023-01-30C16284748780-1f386c649-b474-0266-e053-dadaa90a7c1aDiethylpropion Hydrochloride Extended Release Tablets, 75 mg CIV Rx only
50090-0120-52023-01-30C16284748780-1f386c649-b474-0266-e053-dadaa90a7c1aDiethylpropion Hydrochloride Extended Release Tablets, 75 mg CIV Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0120-0Diethylpropion HydrochlorideER30 in 1 BOTTLETABLET, EXTENDED RELEASE3027
50090-0120-1Diethylpropion HydrochlorideER15 in 1 BOTTLETABLET, EXTENDED RELEASE1527
50090-0120-4Diethylpropion HydrochlorideER7 in 1 BOTTLETABLET, EXTENDED RELEASE727
50090-0120-5Diethylpropion HydrochlorideER28 in 1 BOTTLETABLET, EXTENDED RELEASE2827

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0120-0EA - Each50090-01201e72a94c-f781-42e9-94ab-f977ef5c4f7112021-05-05
50090-0120-5EA - Each50090-012060efe552-bbc6-4dd7-a622-8c7369491a7012021-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIETHYLPROPION HYDROCHLORIDEACTIVE INGREDIENT19V2PL39NGDIETHYLPROPION HYDROCHLORIDE ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS LLC]1
DIETHYLPROPIONACTIVE MOIETYQ94YYU22B8DIETHYLPROPION HYDROCHLORIDE ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS LLC]1
CARBOMER HOMOPOLYMER TYPE AINACTIVE INGREDIENTF68VH75CJCDIETHYLPROPION HYDROCHLORIDE ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS 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 HYDROCHLORIDE ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS LLC]1
MANNITOLINACTIVE INGREDIENT3OWL53L36ADIETHYLPROPION HYDROCHLORIDE ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS LLC]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XDIETHYLPROPION HYDROCHLORIDE ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS 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
50090-0120DIETHYLPROPION HYDROCHLORIDE ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]27Current NDC, Legacy NDC, 4 package rows20230306_04f1a804-00f1-48f5-acfa-0ed1a8544784.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-0120-05009001200030 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-0120-0) 2014-11-280000-00-00NoNoCurrent
50090-0120-15009001200115 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-0120-1) 2014-11-280000-00-00NoNoCurrent
50090-0120-4500900120047 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-0120-4) 2014-11-280000-00-00NoNoCurrent
50090-0120-55009001200528 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-0120-5) 2018-07-260000-00-00NoNoCurrent