Label: DOXEPIN HYDROCHLORIDE capsule
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NDC Code(s):
70771-1390-1,
70771-1390-2,
70771-1390-4,
70771-1390-5, view more70771-1390-7
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated July 3, 2024
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DOXEPIN HYDROCHLORIDE
doxepin hydrochloride capsuleProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1390 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DOXEPIN HYDROCHLORIDE (UNII: 3U9A0FE9N5) (DOXEPIN - UNII:5ASJ6HUZ7D) DOXEPIN 150 mg Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) AMMONIA (UNII: 5138Q19F1X) BUTYL ALCOHOL (UNII: 8PJ61P6TS3) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) FERROSOFERRIC OXIDE (UNII: XM0M87F357) GELATIN (UNII: 2G86QN327L) ISOPROPYL ALCOHOL (UNII: ND2M416302) MAGNESIUM STEARATE (UNII: 70097M6I30) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM LAURYL SULFATE (UNII: 368GB5141J) STARCH, CORN (UNII: O8232NY3SJ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) Product Characteristics Color WHITE (OPAQUE WHITE BODY) , BLUE (OPAQUE BLUE CAP) Score no score Shape CAPSULE Size 21mm Flavor Imprint Code 1301 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1390-7 50 in 1 BOTTLE; Type 0: Not a Combination Product 03/01/2024 2 NDC:70771-1390-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 03/01/2024 3 NDC:70771-1390-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 03/01/2024 4 NDC:70771-1390-4 10 in 1 CARTON 03/01/2024 4 NDC:70771-1390-2 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 ANDA210140 03/01/2024 Labeler - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 918596198 ANALYSIS(70771-1390) , MANUFACTURE(70771-1390)
