Silodosin (Page 5 of 5)

16 HOW SUPPLIED/STORAGE AND HANDLING

Blue / White opaque, hard gelatin 8 mg capsules. Cap is imprinted with “ap” in black ink. Body is imprinted with “SLN 8” in black ink. 8 mg capsules are supplied in unit of use HDPE bottles of:

• 30 capsules (NDC 27241-145-01)
• 90 capsules (NDC 27241-145-03)

Bottles of 30 and 90 capsules are supplied with child-resistant closures.

White, opaque, hard gelatin 4 mg capsules. Cap is imprinted with “ap” in black ink. Body is imprinted with “SLN 4” in black ink. 4 mg capsules are supplied in unit of use HDPE bottles of:

• 30 capsules (NDC 27241-144-01)

Bottles of 30 capsules are supplied with child-resistant closures.

Storage

Store 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]. Protect from light and moisture.
Keep out of reach of children.

17 PATIENT COUNSELING INFORMATION

Advise patients to take silodosin capsules once daily with a meal [see Dosage and Administration (2.1)].
Advise patients about the possible occurrence of symptoms related to postural hypotension (such as dizziness), and should be cautioned about driving, operating machinery, or performing hazardous tasks until they know how silodosin capsules will affect them. This is especially important for those with low blood pressure or who are taking antihypertensive medications [see Warnings and Precautions (5.1)].

Counsel patients on that the most common side effect seen with silodosin capsules are an orgasm with reduced or no semen. This side effect does not pose a safety concern and is reversible with discontinuation of the product [see Adverse Reactions (6.1)].

Counsel patients to tell their ophthalmologist about the use of silodosin capsules before cataract surgery or other procedures involving the eyes, even if the patient is no longer taking silodosin capsules [see Warnings and Precautions (5.7)].

Marketed by:

Ajanta Pharma USA Inc.

Bridgewater, NJ 08807.

Made in INDIA
Revised: 08/2021

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 27241-144-01
30 Capsules
Silodosin Capsules
4 mg
Rx Onlyajanta

NDC 27241-145-01
30 Capsules
Silodosin Capsules
8 mg
Rx Onlyajanta

NDC 27241-145-03
90 Capsules
Silodosin Capsules
8 mg
Rx Only
ajanta

SILODOSIN silodosin capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:27241-145 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SILODOSIN (SILODOSIN) SILODOSIN 8 mg

Inactive Ingredients Ingredient Name Strength MANNITOL STARCH, CORN SODIUM LAURYL SULFATE SODIUM STEARYL FUMARATE FD&C BLUE NO. 1 FD&C RED NO. 3 FD&C RED NO. 40 TITANIUM DIOXIDE GELATIN SHELLAC ALCOHOL ISOPROPYL ALCOHOL BUTYL ALCOHOL PROPYLENE GLYCOL AMMONIA FERROSOFERRIC OXIDE POTASSIUM HYDROXIDE

Product Characteristics Color BLUE, WHITE (opaque) Score no score Shape CAPSULE Size 19mm Flavor Imprint Code ap;SLN8 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:27241-145-01 30 CAPSULE in 1 BOTTLE None 2 NDC:27241-145-03 90 CAPSULE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA211060 12/03/2018

SILODOSIN silodosin capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:27241-144 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SILODOSIN (SILODOSIN) SILODOSIN 4 mg

Inactive Ingredients Ingredient Name Strength MANNITOL STARCH, CORN SODIUM LAURYL SULFATE SODIUM STEARYL FUMARATE TITANIUM DIOXIDE GELATIN SHELLAC ALCOHOL ISOPROPYL ALCOHOL BUTYL ALCOHOL PROPYLENE GLYCOL AMMONIA FERROSOFERRIC OXIDE POTASSIUM HYDROXIDE

Product Characteristics Color WHITE (opaque) Score no score Shape CAPSULE Size 16mm Flavor Imprint Code ap;SLN4 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:27241-144-01 30 CAPSULE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA211060 12/03/2018

Labeler — Ajanta Pharma USA Inc. (557554156)

Registrant — Ajanta Pharma Limited (918594859)

Establishment
Name	Address	ID/FEI	Operations
Ajanta Pharma Ltd., Dahej		862199968	MANUFACTURE (27241-144), MANUFACTURE (27241-145)

Revised: 11/2021 Ajanta Pharma USA Inc.