Label: AMITRIPTYLINE HYDROCHLORIDE tablet, film coated
-
NDC Code(s):
70771-1173-0,
70771-1173-1,
70771-1174-0,
70771-1174-1, view more70771-1175-0, 70771-1175-1, 70771-1176-0, 70771-1176-1, 70771-1177-0, 70771-1177-1, 70771-1178-0, 70771-1178-1
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
Drug Label Information
Updated September 20, 2023
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Medication Guide: HTML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- SPL MEDGUIDE
-
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 70771-1173-1 in bottle of 100 Tablets
Amitriptyline Hydrochloride Tablets USP, 10 mg
Rx only
100 Tablets
NDC 70771-1174-1 in bottle of 100 Tablets
Amitriptyline Hydrochloride Tablets USP, 25 mg
Rx only
100 Tablets
NDC 70771-1175-1 in bottle of 100 Tablets
Amitriptyline Hydrochloride Tablets USP, 50 mg
Rx only
100 Tablets
NDC 70771-1176-1 in bottle of 100 Tablets
Amitriptyline Hydrochloride Tablets USP, 75 mg
Rx only
100 Tablets
NDC 70771-1177-1 in bottle of 100 Tablets
Amitriptyline Hydrochloride Tablets USP, 100 mg
Rx only
100 Tablets
NDC 70771-1178-1 in bottle of 100 Tablets
Amitriptyline Hydrochloride Tablets USP, 150 mg
Rx only
100 Tablets
-
INGREDIENTS AND APPEARANCE
AMITRIPTYLINE HYDROCHLORIDE
amitriptyline hydrochloride tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1173 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMITRIPTYLINE HYDROCHLORIDE (UNII: 26LUD4JO9K) (AMITRIPTYLINE - UNII:1806D8D52K) AMITRIPTYLINE HYDROCHLORIDE 10 mg Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) STARCH, CORN (UNII: O8232NY3SJ) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MAGNESIUM STEARATE (UNII: 70097M6I30) HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6) POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color WHITE (OFF-WHITE) Score no score Shape ROUND (ROUND) Size 5mm Flavor Imprint Code ZA;1 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1173-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 12/26/2017 2 NDC:70771-1173-0 1000 in 1 BOTTLE; Type 0: Not a Combination Product 12/26/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA210086 12/26/2017 AMITRIPTYLINE HYDROCHLORIDE
amitriptyline hydrochloride tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1174 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMITRIPTYLINE HYDROCHLORIDE (UNII: 26LUD4JO9K) (AMITRIPTYLINE - UNII:1806D8D52K) AMITRIPTYLINE HYDROCHLORIDE 25 mg Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) STARCH, CORN (UNII: O8232NY3SJ) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MAGNESIUM STEARATE (UNII: 70097M6I30) HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6) POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TALC (UNII: 7SEV7J4R1U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) ALUMINUM OXIDE (UNII: LMI26O6933) Product Characteristics Color GREEN (LIGHT GREEN) Score no score Shape ROUND (ROUND) Size 6mm Flavor Imprint Code ZA;2 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1174-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 12/26/2017 2 NDC:70771-1174-0 1000 in 1 BOTTLE; Type 0: Not a Combination Product 12/26/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA210086 12/26/2017 AMITRIPTYLINE HYDROCHLORIDE
amitriptyline hydrochloride tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1175 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMITRIPTYLINE HYDROCHLORIDE (UNII: 26LUD4JO9K) (AMITRIPTYLINE - UNII:1806D8D52K) AMITRIPTYLINE HYDROCHLORIDE 50 mg Inactive Ingredients Ingredient Name Strength ALUMINUM OXIDE (UNII: LMI26O6933) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, CORN (UNII: O8232NY3SJ) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color BROWN (BROWN) Score no score Shape ROUND (ROUND) Size 8mm Flavor Imprint Code ZA;3 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1175-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 12/26/2017 2 NDC:70771-1175-0 1000 in 1 BOTTLE; Type 0: Not a Combination Product 12/26/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA210086 12/26/2017 AMITRIPTYLINE HYDROCHLORIDE
amitriptyline hydrochloride tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1176 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMITRIPTYLINE HYDROCHLORIDE (UNII: 26LUD4JO9K) (AMITRIPTYLINE - UNII:1806D8D52K) AMITRIPTYLINE HYDROCHLORIDE 75 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, CORN (UNII: O8232NY3SJ) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color BLUE (LIGHT BLUE) Score no score Shape ROUND (ROUND) Size 11mm Flavor Imprint Code 12;28 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1176-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 12/26/2017 2 NDC:70771-1176-0 1000 in 1 BOTTLE; Type 0: Not a Combination Product 12/26/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA210086 12/26/2017 AMITRIPTYLINE HYDROCHLORIDE
amitriptyline hydrochloride tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1177 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMITRIPTYLINE HYDROCHLORIDE (UNII: 26LUD4JO9K) (AMITRIPTYLINE - UNII:1806D8D52K) AMITRIPTYLINE HYDROCHLORIDE 100 mg Inactive Ingredients Ingredient Name Strength ALUMINUM OXIDE (UNII: LMI26O6933) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, CORN (UNII: O8232NY3SJ) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color ORANGE (ORANGE) Score no score Shape ROUND (ROUND) Size 11mm Flavor Imprint Code 12;29 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1177-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 12/26/2017 2 NDC:70771-1177-0 1000 in 1 BOTTLE; Type 0: Not a Combination Product 12/26/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA210086 12/26/2017 AMITRIPTYLINE HYDROCHLORIDE
amitriptyline hydrochloride tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1178 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMITRIPTYLINE HYDROCHLORIDE (UNII: 26LUD4JO9K) (AMITRIPTYLINE - UNII:1806D8D52K) AMITRIPTYLINE HYDROCHLORIDE 150 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, CORN (UNII: O8232NY3SJ) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE (CREAM TO BEIGE) Score no score Shape CAPSULE (MODIFIED CAPSULE) Size 17mm Flavor Imprint Code 1230 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1178-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 12/26/2017 2 NDC:70771-1178-0 1000 in 1 BOTTLE; Type 0: Not a Combination Product 12/26/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA210086 12/26/2017 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 863362789 ANALYSIS(70771-1173, 70771-1174, 70771-1175, 70771-1176, 70771-1177, 70771-1178) , MANUFACTURE(70771-1173, 70771-1174, 70771-1175, 70771-1176, 70771-1177, 70771-1178)