Label: DOXEPIN tablet
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NDC Code(s):
70771-1528-0,
70771-1528-1,
70771-1528-3,
70771-1528-4, view more70771-1528-5, 70771-1528-9, 70771-1529-0, 70771-1529-1, 70771-1529-3, 70771-1529-4, 70771-1529-5, 70771-1529-9
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated September 18, 2023
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INGREDIENTS AND APPEARANCE
DOXEPIN
doxepin tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1528 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DOXEPIN HYDROCHLORIDE (UNII: 3U9A0FE9N5) (DOXEPIN - UNII:5ASJ6HUZ7D) DOXEPIN 3 mg Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 1 (UNII: H3R47K3TBD) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STARCH, CORN (UNII: O8232NY3SJ) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color BLUE (LIGHT BLUE) Score no score Shape ROUND (ROUND) Size 6mm Flavor Imprint Code 393 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1528-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 08/25/2023 2 NDC:70771-1528-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 08/25/2023 3 NDC:70771-1528-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 08/25/2023 4 NDC:70771-1528-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 08/25/2023 5 NDC:70771-1528-0 1000 in 1 BOTTLE; Type 0: Not a Combination Product 08/25/2023 6 NDC:70771-1528-4 10 in 1 CARTON 08/25/2023 6 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 ANDA202761 08/25/2023 DOXEPIN
doxepin tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1529 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DOXEPIN HYDROCHLORIDE (UNII: 3U9A0FE9N5) (DOXEPIN - UNII:5ASJ6HUZ7D) DOXEPIN 6 mg Inactive Ingredients Ingredient Name Strength D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) TALC (UNII: 7SEV7J4R1U) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color GREEN (LIGHT GREEN) Score no score Shape ROUND (ROUND) Size 6mm Flavor Imprint Code 394 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1529-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 08/25/2023 2 NDC:70771-1529-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 08/25/2023 3 NDC:70771-1529-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 08/25/2023 4 NDC:70771-1529-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 08/25/2023 5 NDC:70771-1529-0 1000 in 1 BOTTLE; Type 0: Not a Combination Product 08/25/2023 6 NDC:70771-1529-4 10 in 1 CARTON 08/25/2023 6 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 ANDA202761 08/25/2023 Labeler - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 863362789 ANALYSIS(70771-1528, 70771-1529) , MANUFACTURE(70771-1528, 70771-1529)
