Venlafaxine hydrochloride tablet, extended release

Ingredients and appearance - Product information

Venlafaxine hydrochloride tablet, extended release- Venlafaxine hydrochloride

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 29033-045
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
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Hypromelloses ( UNII: 3NXW29V3WO)
Lactose monohydrate ( UNII: EWQ57Q8I5X)
Magnesium stearate ( UNII: 70097M6I30)
Maltodextrin ( UNII: 7CVR7L4A2D)
Cellulose, microcrystalline ( UNII: OP1R32D61U)
Polyethylene glycol, unspecified ( UNII: 3WJQ0SDW1A)
Ethylcelluloses ( UNII: 7Z8S9VYZ4B)
Talc ( UNII: 7SEV7J4R1U)
Titanium dioxide ( UNII: 15FIX9V2JP)
Triacetin ( UNII: XHX3C3X673)
Xanthan gum ( UNII: TTV12P4NEE)

Product Characteristics

Color WHITE Imprint Code NV3
Score 1 Shape ROUND
Size 11 mm

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA205468 USA

Venlafaxine hydrochloride tablet, extended release- Venlafaxine hydrochloride

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 29033-046
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Venlafaxine hydrochloride ( UNII: 7D7RX5A8MO)( Venlafaxine - UNII: GRZ5RCB1QG ) 225 mgin 1

Inactive Ingredients

Ingredient Name Code
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Hypromelloses ( UNII: 3NXW29V3WO)
Lactose monohydrate ( UNII: EWQ57Q8I5X)
Magnesium stearate ( UNII: 70097M6I30)
Maltodextrin ( UNII: 7CVR7L4A2D)
Cellulose, microcrystalline ( UNII: OP1R32D61U)
Polyethylene glycol, unspecified ( UNII: 3WJQ0SDW1A)
Ethylcelluloses ( UNII: 7Z8S9VYZ4B)
Talc ( UNII: 7SEV7J4R1U)
Titanium dioxide ( UNII: 15FIX9V2JP)
Triacetin ( UNII: XHX3C3X673)
Xanthan gum ( UNII: TTV12P4NEE)

Product Characteristics

Color WHITE Imprint Code NV4
Score 1 Shape ROUND
Size 12 mm

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA205468 USA

Labeler - Nostrum Laboratories, Inc.( 791142354)

Establishment

Name ID/FEI Business Operations
Nostrum Laboratories, Inc. 791142354 MANUFACTURE( 29033-045, 29033-046), ANALYSIS( 29033-045, 29033-046), pack( 29033-045, 29033-046), label( 29033-045, 29033-046)
Supine Systolic Blood Pressure
Supine Diastolic Blood Pressure
Incidence, rounded to the nearest %, for reactions reported by at least 2% of patients treated with venlafaxine hydrochloride extended-release capsules, except for reactions which had an incidence equal to or less than placebo.
<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.
Adverse reactions for which the venlafaxine hydrochloride extended-release capsules reporting rate was less than or equal to the placebo rate are not included.
<1% means greater than zero but less than 1%.
Mostly "hot flashes."
Mostly "decreased appetite" and "loss of appetite."
Mostly "vivid dreams," "nightmares," and "increased dreaming."
Mostly "blurred vision."
Includes "delayed ejaculation" and "anorgasmia."
Percentage based on the number of males (venlafaxine hydrochloride extended-release capsules = 158, placebo = 153).
Includes "abnormal orgasm" and "anorgasmia."
Percentage based on the number of females (venlafaxine hydrochloride extended-release capsules = 119, placebo = 121).
Based on the number of men and women as appropriate.