DROXIDOPA (Page 4 of 4)

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

Droxidopa capsules are supplied in the following dosage strengths:

100 mg: Hard gelatin, size ‘4’ capsules with opaque white body and opaque light blue cap, imprinted with “733” in black ink on cap and “100 mg” in black ink on body, containing off white to light brown powder.

200 mg: Hard gelatin, size 2 capsule, with an opaque white body and opaque light yellow cap, imprinted with “734” in black ink on cap and “200 mg” in black ink on body, containing off white to light brown powder.

300 mg: Hard gelatin, size 1 capsule, with an opaque white body and opaque light green cap, imprinted with “735” in black ink on cap and “300 mg” in black ink on body, containing off white to light brown powder

100 mg 90-count bottle (NDC code# 69452-256-19)

200 mg 90-count bottle (NDC code# 69452-257-19)

300 mg 90-count bottle (NDC code# 69452-258-19)

Dispense in a tight, Light-resistant container. Do not use if the printed seal under the cap is broken or missing.

16.2 Storage and Handling

Droxidopa capsules should be stored at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

17 PATIENT COUNSELING INFORMATION

Elevations in Blood Pressure

Counsel patients that Droxidopa capsule causes elevations in blood pressure and increases the risk of supine hypertension, which could lead to strokes, heart attacks, and death. Instruct patients to rest and sleep in an upper-body elevated position and monitor blood pressure. Instruct patients how to manage observed blood pressure elevations. To reduce the risk of supine hypertension, in addition to raising the upper body, the late afternoon dose of Droxidopa capsule should be taken at least three hours before bedtime [see Warnings and Precautions (5.1)].

Concomitant Treatments

Counsel patients about the concomitant use of drugs to treat other conditions that may have an additive effect with Droxidopa capsule [see Drug Interactions (7)].

Allergic Reactions

Counsel patients to discontinue Droxidopa capsule and seek immediate medical attention if any signs or symptoms of a hypersensitivity reaction such as anaphylaxis, angioedema, bronchospasm, urticaria or rash occur [see Warnings and Precautions (5.4)].

Lactation

Advise women not to breastfeed during treatment with Droxidopa capsule [see Use in Specific Populations (8.2)].

Food

Patients should take Droxidopa capsule the same way each time, either with food or without food [see Dosage and Administration (2.1)].

Missed Dose

If a dose is missed, patients should take the next dose at the regularly scheduled time and should not double the dose.

Distributed by:

Bionpharma Inc.

600 Alexander Road,

Princeton, NJ 08540.

Revised: 10/2019

Container Label for 100 mg, 200 mg and 300 mg Capsule

containerlabel100mg
(click image for full-size original)

containerlabel200mg
(click image for full-size original)
containerlabel300mg
(click image for full-size original)
DROXIDOPA
droxidopa capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69452-256
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DROXIDOPA (DROXIDOPA) DROXIDOPA 100 mg
Inactive Ingredients
Ingredient Name Strength
MANNITOL
STARCH, CORN
MAGNESIUM STEARATE
SHELLAC
ALCOHOL
ISOPROPYL ALCOHOL
BUTYL ALCOHOL
PROPYLENE GLYCOL
AMMONIA
FERROSOFERRIC OXIDE
POTASSIUM HYDROXIDE
WATER
GELATIN
TITANIUM DIOXIDE
FD&C BLUE NO. 2
FERRIC OXIDE RED
SODIUM LAURYL SULFATE
Product Characteristics
Color white (opaque white body) , blue (opaque light blue cap) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code 733;100mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69452-256-19 90 CAPSULE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA213033 10/01/2021
DROXIDOPA
droxidopa capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69452-257
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DROXIDOPA (DROXIDOPA) DROXIDOPA 200 mg
Inactive Ingredients
Ingredient Name Strength
MANNITOL
STARCH, CORN
MAGNESIUM STEARATE
SHELLAC
ALCOHOL
ISOPROPYL ALCOHOL
BUTYL ALCOHOL
PROPYLENE GLYCOL
AMMONIA
FERROSOFERRIC OXIDE
FERRIC OXIDE YELLOW
POTASSIUM HYDROXIDE
WATER
GELATIN
TITANIUM DIOXIDE
FD&C BLUE NO. 2
SODIUM LAURYL SULFATE
Product Characteristics
Color white (opaque white body) , yellow (opaque light yellow cap) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code 734;200mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69452-257-19 90 CAPSULE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA213033 10/01/2021
DROXIDOPA
droxidopa capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69452-258
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DROXIDOPA (DROXIDOPA) DROXIDOPA 300 mg
Inactive Ingredients
Ingredient Name Strength
MANNITOL
STARCH, CORN
MAGNESIUM STEARATE
SHELLAC
ALCOHOL
ISOPROPYL ALCOHOL
BUTYL ALCOHOL
PROPYLENE GLYCOL
AMMONIA
FERROSOFERRIC OXIDE
POTASSIUM HYDROXIDE
WATER
GELATIN
TITANIUM DIOXIDE
FD&C BLUE NO. 1
FD&C YELLOW NO. 5
FD&C RED NO. 40
SODIUM LAURYL SULFATE
Product Characteristics
Color white (opaque white body) , green (opaque light green cap) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code 735;300mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69452-258-19 90 CAPSULE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA213033 10/01/2021
Labeler — Bionpharma Inc. (079637826)
Registrant — Bionpharma Inc. (079637826)
Establishment
Name Address ID/FEI Operations
Appco Pharma LLC (Unit-II) 078510186 manufacture (69452-256), manufacture (69452-257), manufacture (69452-258)

Revised: 06/2021 Bionpharma Inc.

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