Benzonatate (Page 2 of 2)

PRINCIPAL DISPLAY PANEL — 100 mg Capsule Bottle Label

BIONPHARMA

NDC 69452-143-20

Benzonatate Capsules, USP

100 mg

Protect from Light

Rx only

100 Soft Gelatin Capsules

PRINCIPAL DISPLAY PANEL — 200 mg Capsule Bottle Label

BIONPHARMA

NDC 69452-144-20

Benzonatate Capsules, USP

200 mg

Protect from Light

Rx only

100 Soft Gelatin Capsules

BENZONATATE benzonatate capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69452-143 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzonatate (Benzonatate) Benzonatate 100 mg

Inactive Ingredients Ingredient Name Strength D&C YELLOW NO. 10 GELATIN GLYCERIN WATER

Product Characteristics Color YELLOW Score no score Shape OVAL (CAPSULE) Size 9mm Flavor Imprint Code PA46 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:69452-143-20 100 CAPSULE in 1 BOTTLE, PLASTIC None 2 NDC:69452-143-30 500 CAPSULE in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA081297 08/15/2016

BENZONATATE benzonatate capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69452-144 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzonatate (Benzonatate) Benzonatate 200 mg

Inactive Ingredients Ingredient Name Strength D&C YELLOW NO. 10 GELATIN GLYCERIN WATER

Product Characteristics Color YELLOW Score no score Shape OVAL (CAPSULE) Size 9mm Flavor Imprint Code PA83 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:69452-144-20 100 CAPSULE in 1 BOTTLE, PLASTIC None 2 NDC:69452-144-30 500 CAPSULE in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA081297 08/15/2016

Labeler — Bionpharma Inc. (079637826)

Establishment
Name	Address	ID/FEI	Operations
Patheon Softgels Inc.		002193829	MANUFACTURE (69452-143), MANUFACTURE (69452-144)

Revised: 03/2018 Bionpharma Inc.