Droxidopa by Cadila Healthcare Limited DROXIDOPA capsule

Droxidopa by

Drug Labeling and Warnings

Droxidopa by is a Prescription medication manufactured, distributed, or labeled by Cadila Healthcare Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 70771-1609-9

Droxidopa Capsules, 100 mg

90 Capsules

Rx only

NDC: 70771-1610-9

Droxidopa Capsules, 200 mg

90 Capsules

Rx only

NDC: 70771-1611-9

Droxidopa Capsules, 300 mg

90 Capsules

Rx only

INGREDIENTS AND APPEARANCE

DROXIDOPA 
droxidopa capsule

Product 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 capsule

Product 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 capsule

Product 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)