Diethylpropion HCl Controlled-Release
70025263Diethylpropion HCl USP C-IVImmediate-Release25 mg TabletsDiethylpropion HCl USP C-IVControlled-Release75 mg TabletsRx onlyRev. March 2014
Approved
Approval ID
6c57f874-73b4-4769-8947-0b0b3c5dac1d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 9, 2018
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
Products 2
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 Code50090-0121
Application NumberNDA012546
Product Classification
M
Marketing Category
C73594
G
Generic Name
Diethylpropion hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJuly 10, 2014
FDA Product Classification
INGREDIENTS (6)
DIETHYLPROPION HYDROCHLORIDEActive
Quantity: 75 mg in 1 1
Code: 19V2PL39NG
Classification: ACTIB
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)Inactive
Code: Z135WT9208
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
ZINC STEARATEInactive
Code: H92E6QA4FV
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
TARTARIC ACIDInactive
Code: W4888I119H
Classification: IACT
Diethylpropion hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50090-0326
Application NumberNDA011722
Product Classification
M
Marketing Category
C73594
G
Generic Name
Diethylpropion hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJuly 10, 2014
FDA Product Classification
INGREDIENTS (6)
DIETHYLPROPION HYDROCHLORIDEActive
Quantity: 25 mg in 1 1
Code: 19V2PL39NG
Classification: ACTIB
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TARTARIC ACIDInactive
Code: W4888I119H
Classification: IACT