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

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.