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: 0615-7620
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 ( UNII: 2G86QN327L)
Polyethylene glycol 400 ( UNII: B697894SGQ)
Povidone k30 ( UNII: U725QWY32X)
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)

Product Characteristics

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

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA076565 USA

Labeler - NCS HealthCare of KY, Inc dba Vangard Labs( 050052943)

Establishment

Name ID/FEI Business Operations
NCS HealthCare of KY, Inc dba Vangard Labs 050052943 REPACK( 0615-7620)
Supine Systolic Blood Pressure
Supine Diastolic Blood Pressure
Two of the major depressive disorder studies were flexible dose and one was fixed dose.
In U.S. placebo-controlled trials for major depressive disorder, the following were also common events leading to discontinuation and were considered to be drug-related for venlafaxine hydrochloride extended-release capsule-treated patients (% venlafaxine hydrochloride extended-release capsules [n = 192], % Placebo [n = 202]): hypertension (1%, < 1%); diarrhea (1%, 0%); paresthesia (1%, 0%); tremor (1%, 0%); abnormal vision, mostly blurred vision (1%, 0%); and abnormal, mostly delayed, ejaculation (1%, 0%).
Incidence, rounded to the nearest %, for events reported by at least 2% of patients treated with venlafaxine hydrochloride extended-release capsules, except the following events which had an incidence equal to or less than placebo: abdominal pain, accidental injury, anxiety, back pain, bronchitis, diarrhea, dysmenorrhea, dyspepsia, flu syndrome, headache, infection, pain, palpitation, rhinitis, and sinusitis.
< 1% indicates an incidence greater than zero but less than 1%.
Mostly hot flashes.
Mostly vivid dreams, nightmares, and increased dreaming.
Mostly blurred vision and difficulty focusing eyes.
Mostly delayed ejaculation.
Incidence is based on the number of male patients.
Mostly delayed orgasm or anorgasmia.
Incidence is based on the number of female patients.