MedPath

Diethylpropion Hydrochloride

Diethylpropion HCl USP C-IV Immediate-Release 25 mg Tablets Rx only

Approved
Approval ID

0971fa2e-d660-48b0-9fbb-96a2db167b92

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 23, 2017

Manufacturers
FDA

Apotheca Inc.

DUNS: 051457844

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Diethylpropion hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code12634-530
Application NumberNDA011722
Product Classification
M
Marketing Category
C73594
G
Generic Name
Diethylpropion hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 23, 2017
FDA Product Classification

INGREDIENTS (6)

STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TARTARIC ACIDInactive
Code: W4888I119H
Classification: IACT
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
DIETHYLPROPION HYDROCHLORIDEActive
Quantity: 25 mg in 1 1
Code: 19V2PL39NG
Classification: ACTIB

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Diethylpropion Hydrochloride - FDA Drug Approval Details