Diethylpropion hcl controlled-release tablet

Ingredients and appearance - Product information

Diethylpropion hcl controlled-release tablet- Diethylpropion hydrochloride

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 50090-0121
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Diethylpropion hydrochloride ( UNII: 19V2PL39NG)( Diethylpropion - UNII: Q94YYU22B8 ) 75 mgin 1

Inactive Ingredients

Ingredient Name Code
Carbomer homopolymer type b (allyl sucrose crosslinked) ( UNII: Z135WT9208)
Mannitol ( UNII: 3OWL53L36A)
Povidone, unspecified ( UNII: FZ989GH94E)
Tartaric acid ( UNII: W4888I119H)
Zinc stearate ( UNII: H92E6QA4FV)

Product Characteristics

Color WHITE Imprint Code Watson;782
Score 1 Shape OVAL (capsule-shaped)
Size 19 mm

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 50090-0121-0 30 in 1 BOTTLE 2014/11/28
2 NDC: 50090-0121-1 15 in 1 BOTTLE 2013/09/06
3 NDC: 50090-0121-4 7 in 1 BOTTLE 2013/10/16

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
NDA NDA012546 USA 2013/10/16

Diethylpropion hcl immediate-release tablet- Diethylpropion hydrochloride

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 50090-0326
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Diethylpropion hydrochloride ( UNII: 19V2PL39NG)( Diethylpropion - UNII: Q94YYU22B8 ) 25 mgin 1

Inactive Ingredients

Ingredient Name Code
Starch, corn ( UNII: O8232NY3SJ)
Lactose, unspecified form ( UNII: J2B2A4N98G)
Magnesium stearate ( UNII: 70097M6I30)
Talc ( UNII: 7SEV7J4R1U)
Tartaric acid ( UNII: W4888I119H)

Product Characteristics

Color WHITE Imprint Code Watson;783
Score 1 Shape ROUND
Size 10 mm

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 50090-0326-4 28 in 1 BOTTLE 2014/11/28
2 NDC: 50090-0326-5 90 in 1 BOTTLE 2014/11/28
3 NDC: 50090-0326-7 60 in 1 BOTTLE 2014/11/28
4 NDC: 50090-0326-8 30 in 1 BOTTLE 2014/11/28
5 NDC: 50090-0326-3 14 in 1 BOTTLE 2014/11/28

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
NDA NDA011722 USA 2014/11/28

Labeler - A-S Medication Solutions( 830016429)

Establishment

Name ID/FEI Business Operations
A-S Medication Solutions 830016429 RELABEL( 50090-0121, 50090-0326), REPACK( 50090-0121, 50090-0326)

Diethylpropion hydrochloride

Diethylpropion hydrochloride