Label: TRAZODONE HYDROCHLORIDE tablet
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NDC Code(s):
70771-1128-0,
70771-1128-1,
70771-1128-2,
70771-1128-3, view more70771-1128-4, 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, 70771-1938-0, 70771-1938-1, 70771-1938-5, 70771-1939-0, 70771-1939-1, 70771-1939-5
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated January 23, 2026
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Trazodone Hydrochloride Tablets USP, 50 mg
100 Tablets
Rx only
Trazodone Hydrochloride Tablets USP, 100 mg
100 Tablets
Rx only
Trazodone Hydrochloride Tablets USP, 150 mg
100 Tablets
Rx only
Trazodone Hydrochloride Tablets USP, 300 mg
100 Tablets
Rx only
Trazodone Hydrochloride Tablets USP, 50 mg
100 Tablets
Rx only
Trazodone Hydrochloride Tablets USP, 100 mg
100 Tablets
Rx only
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INGREDIENTS AND APPEARANCE
TRAZODONE HYDROCHLORIDE
trazodone hydrochloride tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1128 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRAZODONE HYDROCHLORIDE (UNII: 6E8ZO8LRNM) (TRAZODONE - UNII:YBK48BXK30) TRAZODONE HYDROCHLORIDE 50 mg Inactive Ingredients Ingredient Name Strength 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 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1128-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 12/11/2017 12/31/2028 2 NDC:70771-1128-0 1000 in 1 BOTTLE; Type 0: Not a Combination Product 12/11/2017 12/31/2028 3 NDC:70771-1128-4 10 in 1 CARTON 12/11/2017 12/31/2028 3 NDC:70771-1128-2 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 4 NDC:70771-1128-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 12/11/2017 12/31/2028 5 NDC:70771-1128-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 12/11/2017 12/31/2028 6 NDC:70771-1128-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 12/11/2017 12/31/2028 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA205253 12/11/2017 12/31/2028 TRAZODONE HYDROCHLORIDE
trazodone hydrochloride tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1129 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRAZODONE HYDROCHLORIDE (UNII: 6E8ZO8LRNM) (TRAZODONE - UNII:YBK48BXK30) TRAZODONE HYDROCHLORIDE 100 mg Inactive Ingredients Ingredient Name Strength 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 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1129-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 12/11/2017 12/31/2028 2 NDC:70771-1129-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 12/11/2017 12/31/2028 3 NDC:70771-1129-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 12/11/2017 12/31/2028 4 NDC:70771-1129-0 1000 in 1 BOTTLE; Type 0: Not a Combination Product 12/11/2017 12/31/2028 5 NDC:70771-1129-4 10 in 1 CARTON 12/11/2017 12/31/2028 5 NDC:70771-1129-2 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 6 NDC:70771-1129-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 12/11/2017 12/31/2028 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA205253 12/11/2017 12/31/2028 TRAZODONE HYDROCHLORIDE
trazodone hydrochloride tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1130 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRAZODONE HYDROCHLORIDE (UNII: 6E8ZO8LRNM) (TRAZODONE - UNII:YBK48BXK30) TRAZODONE HYDROCHLORIDE 150 mg Inactive Ingredients Ingredient Name Strength 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 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA205253 12/11/2017 TRAZODONE HYDROCHLORIDE
trazodone hydrochloride tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1131 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRAZODONE HYDROCHLORIDE (UNII: 6E8ZO8LRNM) (TRAZODONE - UNII:YBK48BXK30) TRAZODONE HYDROCHLORIDE 300 mg Inactive Ingredients Ingredient Name Strength 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 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA205253 12/11/2017 TRAZODONE HYDROCHLORIDE
trazodone hydrochloride tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1938 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRAZODONE HYDROCHLORIDE (UNII: 6E8ZO8LRNM) (TRAZODONE - UNII:YBK48BXK30) TRAZODONE HYDROCHLORIDE 50 mg Inactive Ingredients Ingredient Name Strength 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 05 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1938-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 01/22/2026 2 NDC:70771-1938-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 01/22/2026 3 NDC:70771-1938-0 1000 in 1 BOTTLE; Type 0: Not a Combination Product 01/22/2026 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA205253 01/22/2026 TRAZODONE HYDROCHLORIDE
trazodone hydrochloride tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1939 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRAZODONE HYDROCHLORIDE (UNII: 6E8ZO8LRNM) (TRAZODONE - UNII:YBK48BXK30) TRAZODONE HYDROCHLORIDE 100 mg Inactive Ingredients Ingredient Name Strength 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 06 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1939-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 01/22/2026 2 NDC:70771-1939-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 01/22/2026 3 NDC:70771-1939-0 1000 in 1 BOTTLE; Type 0: Not a Combination Product 01/22/2026 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA205253 01/22/2026 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 863362789 ANALYSIS(70771-1128, 70771-1129, 70771-1130, 70771-1131) , MANUFACTURE(70771-1128, 70771-1129, 70771-1130, 70771-1131) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 677605858 ANALYSIS(70771-1128, 70771-1129, 70771-1130, 70771-1131, 70771-1938, 70771-1939) , MANUFACTURE(70771-1128, 70771-1129, 70771-1130, 70771-1131, 70771-1938, 70771-1939) Establishment Name Address ID/FEI Business Operations Zydus Pharmaceuticals Limited 650173735 MANUFACTURE(70771-1130, 70771-1131, 70771-1938, 70771-1938) , ANALYSIS(70771-1130, 70771-1131, 70771-1938, 70771-1938)