Venlafaxine hydrochloride capsule, extended release

Ingredients and appearance - Product information

Venlafaxine hydrochloride capsule, extended release- Venlafaxine hydrochloride

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 50090-1214
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Venlafaxine hydrochloride ( UNII: 7D7RX5A8MO)( Venlafaxine - UNII: GRZ5RCB1QG ) 75 mgin 1

Inactive Ingredients

Ingredient Name Code
Ferrosoferric oxide ( UNII: XM0M87F357)
Dibutyl sebacate ( UNII: 4W5IH7FLNY)
Ethylcellulose (7 mpa.s) ( UNII: H3UP11403C)
Gelatin, unspecified ( UNII: 2G86QN327L)
Polyethylene glycol 400 ( UNII: B697894SGQ)
Povidone k30 ( UNII: U725QWY32X)
Propylene glycol ( UNII: 6DC9Q167V3)
Shellac ( UNII: 46N107B71O)
Sucrose ( UNII: C151H8M554)
Starch, corn ( UNII: O8232NY3SJ)
Fd&c yellow no. 6 ( UNII: H77VEI93A8)
Talc ( UNII: 7SEV7J4R1U)
Titanium dioxide ( UNII: 15FIX9V2JP)
D&c yellow no. 10 ( UNII: 35SW5USQ3G)
Potassium hydroxide ( UNII: WZH3C48M4T)

Product Characteristics

Color BROWN (buff) Imprint Code 93;7385;93;7385
Score 1 Shape CAPSULE
Size 19 mm

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 50090-1214-0 30 in 1 BOTTLE 2014/11/28
2 NDC: 50090-1214-1 90 in 1 BOTTLE 2014/11/28

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA076565 USA 2014/11/28

Venlafaxine hydrochloride capsule, extended release- Venlafaxine hydrochloride

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 50090-1216
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Venlafaxine hydrochloride ( UNII: 7D7RX5A8MO)( Venlafaxine - UNII: GRZ5RCB1QG ) 150 mgin 1

Inactive Ingredients

Ingredient Name Code
Ferrosoferric oxide ( UNII: XM0M87F357)
Dibutyl sebacate ( UNII: 4W5IH7FLNY)
Ethylcellulose (7 mpa.s) ( UNII: H3UP11403C)
Gelatin, unspecified ( UNII: 2G86QN327L)
Polyethylene glycol 400 ( UNII: B697894SGQ)
Povidone k30 ( UNII: U725QWY32X)
Propylene glycol ( UNII: 6DC9Q167V3)
Shellac ( UNII: 46N107B71O)
Sucrose ( UNII: C151H8M554)
Starch, corn ( UNII: O8232NY3SJ)
Fd&c yellow no. 6 ( UNII: H77VEI93A8)
Talc ( UNII: 7SEV7J4R1U)
Titanium dioxide ( UNII: 15FIX9V2JP)
Potassium hydroxide ( UNII: WZH3C48M4T)

Product Characteristics

Color ORANGE (light-orange) Size 23 mm
Shape CAPSULE Score 1
Imprint Code 93;7386;93;7386

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 50090-1216-0 30 in 1 BOTTLE 2014/11/28
2 NDC: 50090-1216-1 90 in 1 BOTTLE 2014/11/28

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA076565 USA 2014/11/28

Venlafaxine hydrochloride capsule, extended release- Venlafaxine hydrochloride

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 50090-1406
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Venlafaxine hydrochloride ( UNII: 7D7RX5A8MO)( Venlafaxine - UNII: GRZ5RCB1QG ) 37.5 mgin 1

Inactive Ingredients

Ingredient Name Code
Ferrosoferric oxide ( UNII: XM0M87F357)
Dibutyl sebacate ( UNII: 4W5IH7FLNY)
Ethylcellulose (7 mpa.s) ( UNII: H3UP11403C)
Gelatin, unspecified ( UNII: 2G86QN327L)
Polyethylene glycol 400 ( UNII: B697894SGQ)
Povidone k30 ( UNII: U725QWY32X)
Propylene glycol ( UNII: 6DC9Q167V3)
Shellac ( UNII: 46N107B71O)
Sucrose ( UNII: C151H8M554)
Starch, corn ( UNII: O8232NY3SJ)
Fd&c yellow no. 6 ( UNII: H77VEI93A8)
Talc ( UNII: 7SEV7J4R1U)
Titanium dioxide ( UNII: 15FIX9V2JP)
D&c yellow no. 10 ( UNII: 35SW5USQ3G)
Potassium hydroxide ( UNII: WZH3C48M4T)

Product Characteristics

Color BROWN (buff) Size 18 mm
Shape CAPSULE Score 1
Imprint Code 93;7384;93;7384

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 50090-1406-0 30 in 1 BOTTLE 2014/11/28

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA076565 USA 2014/11/28

Labeler - A-S Medication Solutions( 830016429)

Establishment

Name ID/FEI Business Operations
A-S Medication Solutions 830016429 RELABEL( 50090-1214, 50090-1216, 50090-1406), REPACK( 50090-1214, 50090-1216, 50090-1406)

Venlafaxine hydrochloride

Venlafaxine hydrochloride

Venlafaxine hydrochloride

p < 0.001 versus placebo
p = 0.041
The discontinuation rates for weight loss were 0.7% for patients receiving either venlafaxine hydrochloride extended-release capsules or placebo.
In addition, in the premarketing assessment of venlafaxine tablets, multiple doses were administered to 2,897 patients in studies for MDD.
Percentages based on the number of men (venlafaxine hydrochloride extended-release capsules, n = 1,440; placebo, n = 923)
Percentages based on the number of women (venlafaxine hydrochloride extended-release capsules, n = 2,118; placebo, n = 1,274)
In addition, in the premarketing assessment of venlafaxine tablets (immediate release), 12% (357/2,897) of patients were 65 years of age.
Difference (drug minus placebo) in least-squares mean change from baseline
Doses statistically significantly superior to placebo.
Difference (drug minus placebo) in least-squares mean change from baseline
Difference (drug minus placebo) in least-squares mean change from baseline
Odds ratio (drug to placebo) in terms of probability of free of full-symptom panic attacks based on logistic regression model.

95%CI: 95% confidence interval without adjusting for multiple dose arms.
Doses statistically significantly superior to placebo.