DailyMed - TRAZODONE HYDROCHLORIDE tablet

NDC Code(s): 70771-1128-0, 70771-1128-1, 70771-1128-2, 70771-1128-3, view more
70771-1128-4, 70771-1128-5, 70771-1128-9, 70771-1129-0, 70771-1129-1, 70771-1129-2, 70771-1129-3, 70771-1129-4, 70771-1129-5, 70771-1129-9, 70771-1130-0, 70771-1130-1, 70771-1130-2, 70771-1130-3, 70771-1130-4, 70771-1130-5, 70771-1130-9, 70771-1131-0, 70771-1131-1, 70771-1131-2, 70771-1131-3, 70771-1131-4, 70771-1131-5, 70771-1131-9
Packager: Zydus Lifesciences Limited

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

Drug Label Information

Updated October 31, 2022

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SPL MEDGUIDE
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1128-1

Trazodone Hydrochloride Tablets USP, 50 mg

100 Tablets

Rx only

NDC 70771-1129-1

Trazodone Hydrochloride Tablets USP, 100 mg

100 Tablets

Rx only

NDC 70771-1130-1

Trazodone Hydrochloride Tablets USP, 150 mg

100 Tablets

Rx only

NDC 70771-1131-1

Trazodone Hydrochloride Tablets USP, 300 mg

100 Tablets

Rx only

INGREDIENTS AND APPEARANCE

TRAZODONE HYDROCHLORIDE
trazodone hydrochloride tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1128
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TRAZODONE HYDROCHLORIDE (UNII: 6E8ZO8LRNM) (TRAZODONE - UNII:YBK48BXK30)	TRAZODONE HYDROCHLORIDE	50 mg

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics
Color	WHITE (WHITE TO OFF-WHITE)	Score	2 pieces
Shape	ROUND (ROUND)	Size	8mm
Flavor		Imprint Code	8;05
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70771-1128-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	12/11/2017
2	NDC:70771-1128-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	12/11/2017
3	NDC:70771-1128-5	500 in 1 BOTTLE; Type 0: Not a Combination Product	12/11/2017
4	NDC:70771-1128-0	1000 in 1 BOTTLE; Type 0: Not a Combination Product	12/11/2017
5	NDC:70771-1128-4	10 in 1 CARTON	12/11/2017
5	NDC:70771-1128-2	10 in 1 BLISTER PACK; Type 0: Not a Combination Product
6	NDC:70771-1128-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	12/11/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA205253	12/11/2017

TRAZODONE HYDROCHLORIDE
trazodone hydrochloride tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1129
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TRAZODONE HYDROCHLORIDE (UNII: 6E8ZO8LRNM) (TRAZODONE - UNII:YBK48BXK30)	TRAZODONE HYDROCHLORIDE	100 mg

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics
Color	WHITE (WHITE TO OFF-WHITE)	Score	2 pieces
Shape	ROUND (ROUND)	Size	10mm
Flavor		Imprint Code	8;06
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70771-1129-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	12/11/2017
2	NDC:70771-1129-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	12/11/2017
3	NDC:70771-1129-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	12/11/2017
4	NDC:70771-1129-5	500 in 1 BOTTLE; Type 0: Not a Combination Product	12/11/2017
5	NDC:70771-1129-0	1000 in 1 BOTTLE; Type 0: Not a Combination Product	12/11/2017
6	NDC:70771-1129-4	10 in 1 CARTON	12/11/2017
6	NDC:70771-1129-2	10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA205253	12/11/2017

TRAZODONE HYDROCHLORIDE
trazodone hydrochloride tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1130
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TRAZODONE HYDROCHLORIDE (UNII: 6E8ZO8LRNM) (TRAZODONE - UNII:YBK48BXK30)	TRAZODONE HYDROCHLORIDE	150 mg

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics
Color	WHITE (WHITE TO OFF-WHITE)	Score	3 pieces
Shape	OVAL (OVAL)	Size	17mm
Flavor		Imprint Code	8;07
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70771-1130-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	12/11/2017
2	NDC:70771-1130-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	12/11/2017
3	NDC:70771-1130-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	12/11/2017
4	NDC:70771-1130-5	500 in 1 BOTTLE; Type 0: Not a Combination Product	12/11/2017
5	NDC:70771-1130-0	1000 in 1 BOTTLE; Type 0: Not a Combination Product	12/11/2017
6	NDC:70771-1130-4	10 in 1 CARTON	12/11/2017
6	NDC:70771-1130-2	10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA205253	12/11/2017

TRAZODONE HYDROCHLORIDE
trazodone hydrochloride tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1131
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TRAZODONE HYDROCHLORIDE (UNII: 6E8ZO8LRNM) (TRAZODONE - UNII:YBK48BXK30)	TRAZODONE HYDROCHLORIDE	300 mg

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics
Color	WHITE (WHITE TO OFF-WHITE)	Score	3 pieces
Shape	OVAL (OVAL)	Size	21mm
Flavor		Imprint Code	8;08
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70771-1131-3	30 in 1 BOTTLE; Type 1: Convenience Kit of Co-Package	12/11/2017
2	NDC:70771-1131-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	12/11/2017
3	NDC:70771-1131-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	12/11/2017
4	NDC:70771-1131-5	500 in 1 BOTTLE; Type 0: Not a Combination Product	12/11/2017
5	NDC:70771-1131-0	1000 in 1 BOTTLE; Type 0: Not a Combination Product	12/11/2017
6	NDC:70771-1131-4	10 in 1 CARTON	12/11/2017
6	NDC:70771-1131-2	10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA205253	12/11/2017

Labeler - Zydus Lifesciences Limited (918596198)

Registrant - Zydus Lifesciences Limited (918596198)

Name	Address	ID/FEI	Business Operations
Establishment
Zydus Lifesciences Limited		863362789	ANALYSIS(70771-1128, 70771-1129, 70771-1130, 70771-1131) , MANUFACTURE(70771-1128, 70771-1129, 70771-1130, 70771-1131)

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Published Date (What is this?)	Version	Files
Nov 8, 2022	5 (current)	download
Sep 24, 2020	4	download
Dec 20, 2019	3	download
Dec 28, 2018	2	download
Dec 12, 2017	1	download

	RxCUI	RxNorm NAME	RxTTY
1	856364	traZODone HCl 150 MG Oral Tablet	PSN
2	856364	trazodone hydrochloride 150 MG Oral Tablet	SCD
3	856369	traZODone HCl 300 MG Oral Tablet	PSN
4	856369	trazodone hydrochloride 300 MG Oral Tablet	SCD
5	856373	traZODone HCl 100 MG Oral Tablet	PSN
6	856373	trazodone hydrochloride 100 MG Oral Tablet	SCD
7	856377	traZODone HCl 50 MG Oral Tablet	PSN
8	856377	trazodone hydrochloride 50 MG Oral Tablet	SCD

Label: TRAZODONE HYDROCHLORIDE tablet

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	NDC
1	70771-1128-0
2	70771-1128-1
3	70771-1128-2
4	70771-1128-3
5	70771-1128-4
6	70771-1128-5
7	70771-1128-9
8	70771-1129-0
9	70771-1129-1
10	70771-1129-2
11	70771-1129-3
12	70771-1129-4
13	70771-1129-5
14	70771-1129-9
15	70771-1130-0
16	70771-1130-1
17	70771-1130-2
18	70771-1130-3
19	70771-1130-4
20	70771-1130-5
21	70771-1130-9
22	70771-1131-0
23	70771-1131-1
24	70771-1131-2
25	70771-1131-3
26	70771-1131-4
27	70771-1131-5
28	70771-1131-9

Label: TRAZODONE HYDROCHLORIDE tablet

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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

TRAZODONE HYDROCHLORIDE tablet

Number of versions: 5

TRAZODONE HYDROCHLORIDE tablet

TRAZODONE HYDROCHLORIDE tablet

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TRAZODONE HYDROCHLORIDE tablet

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