Label: DROXIDOPA capsule
- NDC Code(s): 70771-1609-9, 70771-1610-9, 70771-1611-9
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated August 25, 2022
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INGREDIENTS AND APPEARANCE
DROXIDOPA
droxidopa capsuleProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1609 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DROXIDOPA (UNII: J7A92W69L7) (DROXIDOPA - UNII:J7A92W69L7) DROXIDOPA 100 mg Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) FERROSOFERRIC OXIDE (UNII: XM0M87F357) GELATIN (UNII: 2G86QN327L) MAGNESIUM STEARATE (UNII: 70097M6I30) MANNITOL (UNII: 3OWL53L36A) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) SODIUM LAURYL SULFATE (UNII: 368GB5141J) STARCH, CORN (UNII: O8232NY3SJ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) Product Characteristics Color BLUE (opaque blue cap) , WHITE (opaque white body) Score no score Shape CAPSULE Size 16mm Flavor Imprint Code 1389 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1609-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 02/19/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA211818 02/19/2021 DROXIDOPA
droxidopa capsuleProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1610 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DROXIDOPA (UNII: J7A92W69L7) (DROXIDOPA - UNII:J7A92W69L7) DROXIDOPA 200 mg Inactive Ingredients Ingredient Name Strength FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) GELATIN (UNII: 2G86QN327L) MAGNESIUM STEARATE (UNII: 70097M6I30) MANNITOL (UNII: 3OWL53L36A) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) SODIUM LAURYL SULFATE (UNII: 368GB5141J) STARCH, CORN (UNII: O8232NY3SJ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) Product Characteristics Color YELLOW (opaque yellow cap) , WHITE (opaque white body) Score no score Shape CAPSULE Size 18mm Flavor Imprint Code 1390 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1610-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 02/19/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA211818 02/19/2021 DROXIDOPA
droxidopa capsuleProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1611 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DROXIDOPA (UNII: J7A92W69L7) (DROXIDOPA - UNII:J7A92W69L7) DROXIDOPA 300 mg Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) GELATIN (UNII: 2G86QN327L) MAGNESIUM STEARATE (UNII: 70097M6I30) MANNITOL (UNII: 3OWL53L36A) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) SODIUM LAURYL SULFATE (UNII: 368GB5141J) STARCH, CORN (UNII: O8232NY3SJ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) Product Characteristics Color GREEN (opaque green cap) , WHITE (opaque white body) Score no score Shape CAPSULE Size 20mm Flavor Imprint Code 1391 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1611-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 02/19/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA211818 02/19/2021 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (863362789) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 863362789 ANALYSIS(70771-1609, 70771-1610, 70771-1611) , MANUFACTURE(70771-1609, 70771-1610, 70771-1611)
