DailyMed - VENLAFAXINE tablet, extended release

NDC Code(s): 70771-1649-1, 70771-1649-3, 70771-1649-9, 70771-1650-1, view more
70771-1650-3, 70771-1650-9, 70771-1651-1, 70771-1651-3, 70771-1651-9, 70771-1652-1, 70771-1652-3, 70771-1652-9
Packager: Zydus Lifesciences Limited

Category: HUMAN PRESCRIPTION DRUG LABEL
DEA Schedule: None
Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated September 28, 2023

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SPL UNCLASSIFIED SECTION
SPL MEDGUIDE
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Venlafaxine extended-release tablets, 37.5 mg

NDC 70771-1649-3

30 Tablets

Rx only

Venlafaxine extended-release tablets, 75 mg

NDC 70771-1650-3

30 Tablets

Rx only

Venlafaxine extended-release tablets, 150 mg

NDC 70771-1651-3

30 Tablets

Rx only

Venlafaxine extended-release tablets, 225 mg

NDC 70771-1652-3

30 Tablets

Rx only

INGREDIENTS AND APPEARANCE

VENLAFAXINE
venlafaxine tablet, extended release

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1649
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
VENLAFAXINE HYDROCHLORIDE (UNII: 7D7RX5A8MO) (VENLAFAXINE - UNII:GRZ5RCB1QG)	VENLAFAXINE	37.5 mg

Ingredient Name	Strength
Inactive Ingredients
CELLULOSE ACETATE (UNII: 3J2P07GVB6)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POVIDONE K90 (UNII: RDH86HJV5Z)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHELLAC (UNII: 46N107B71O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	WHITE (off-white)	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	1348
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70771-1649-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2022
2	NDC:70771-1649-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2022
3	NDC:70771-1649-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA215622	09/01/2022

VENLAFAXINE
venlafaxine tablet, extended release

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1650
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
VENLAFAXINE HYDROCHLORIDE (UNII: 7D7RX5A8MO) (VENLAFAXINE - UNII:GRZ5RCB1QG)	VENLAFAXINE	75 mg

Ingredient Name	Strength
Inactive Ingredients
CELLULOSE ACETATE (UNII: 3J2P07GVB6)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POVIDONE K90 (UNII: RDH86HJV5Z)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHELLAC (UNII: 46N107B71O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	WHITE (off-white)	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	1349
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70771-1650-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2022
2	NDC:70771-1650-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2022
3	NDC:70771-1650-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA215622	09/01/2022

VENLAFAXINE
venlafaxine tablet, extended release

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1651
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
VENLAFAXINE HYDROCHLORIDE (UNII: 7D7RX5A8MO) (VENLAFAXINE - UNII:GRZ5RCB1QG)	VENLAFAXINE	150 mg

Ingredient Name	Strength
Inactive Ingredients
CELLULOSE ACETATE (UNII: 3J2P07GVB6)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POVIDONE K90 (UNII: RDH86HJV5Z)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHELLAC (UNII: 46N107B71O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	WHITE (off-white)	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	1350
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70771-1651-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2022
2	NDC:70771-1651-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2022
3	NDC:70771-1651-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA215622	09/01/2022

VENLAFAXINE
venlafaxine tablet, extended release

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1652
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
VENLAFAXINE HYDROCHLORIDE (UNII: 7D7RX5A8MO) (VENLAFAXINE - UNII:GRZ5RCB1QG)	VENLAFAXINE	225 mg

Ingredient Name	Strength
Inactive Ingredients
CELLULOSE ACETATE (UNII: 3J2P07GVB6)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POVIDONE K90 (UNII: RDH86HJV5Z)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHELLAC (UNII: 46N107B71O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	WHITE (off-white)	Score	no score
Shape	ROUND	Size	12mm
Flavor		Imprint Code	1352
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70771-1652-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2022
2	NDC:70771-1652-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2022
3	NDC:70771-1652-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA215622	09/01/2022

Labeler - Zydus Lifesciences Limited (918596198)

Name	Address	ID/FEI	Business Operations
Establishment
Zydus Lifesciences Limited		863362789	ANALYSIS(70771-1649, 70771-1650, 70771-1651, 70771-1652) , MANUFACTURE(70771-1649, 70771-1650, 70771-1651, 70771-1652)

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Published Date (What is this?)	Version	Files
Oct 5, 2023	2 (current)	download
Oct 11, 2022	1	download

	RxCUI	RxNorm NAME	RxTTY
1	808744	venlafaxine HCl 150 MG 24HR Extended Release Oral Tablet	PSN
2	808744	24 HR venlafaxine 150 MG Extended Release Oral Tablet	SCD
3	808744	venlafaxine 150 MG 24 HR Extended Release Oral Tablet	SY
4	808744	venlafaxine 150 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral Tablet	SY
5	808748	venlafaxine HCl 225 MG 24HR Extended Release Oral Tablet	PSN
6	808748	24 HR venlafaxine 225 MG Extended Release Oral Tablet	SCD
7	808748	venlafaxine 225 MG 24 HR Extended Release Oral Tablet	SY
8	808748	venlafaxine 225 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral Tablet	SY
9	808751	venlafaxine HCl 37.5 MG 24HR Extended Release Oral Tablet	PSN
10	808751	24 HR venlafaxine 37.5 MG Extended Release Oral Tablet	SCD
11	808751	venlafaxine 37.5 MG 24 HR Extended Release Oral Tablet	SY
12	808751	venlafaxine 37.5 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral Tablet	SY
13	808753	venlafaxine HCl 75 MG 24HR Extended Release Oral Tablet	PSN
14	808753	24 HR venlafaxine 75 MG Extended Release Oral Tablet	SCD
15	808753	venlafaxine 75 MG 24 HR Extended Release Oral Tablet	SY
16	808753	venlafaxine 75 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral Tablet	SY

Label: VENLAFAXINE tablet, extended release

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	NDC
1	70771-1649-1
2	70771-1649-3
3	70771-1649-9
4	70771-1650-1
5	70771-1650-3
6	70771-1650-9
7	70771-1651-1
8	70771-1651-3
9	70771-1651-9
10	70771-1652-1
11	70771-1652-3
12	70771-1652-9

Label: VENLAFAXINE tablet, extended release

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Drug Label Info

Safety

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More Info For This Drug

Drug Label Information

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Safety

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More Info on this Drug

VENLAFAXINE tablet, extended release

Number of versions: 2

VENLAFAXINE tablet, extended release

VENLAFAXINE tablet, extended release

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VENLAFAXINE tablet, extended release

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.