Dexamethasone (Page 4 of 4)

HOW SUPPLIED

Dexamethasone Tablets, USP are available as follows:

1.5 mg tablets are supplied as a pink, round, shallow, biconvex tablet, scored on one side and debossed with “N 401” on the other side.

NDC 70954-401-10: Bottle of 100 Tablets

2 mg tablets are supplied as a white to off white, round, shallow, biconvex tablet, scored on one side and debossed with “N 402” on the other side.

NDC 70954-402-10: Bottle of 100 Tablets

4 mg tablets are supplied as a green, round, shallow, biconvex tablet, scored on one side and debossed with “N 403” on the other side.

NDC 70954-403-10: Bottle of 100 Tablets

NDC 70954-403-30: Unit dose blister packages of 100 (10 cards of 10 tablets each)

6 mg tablets are supplied as an aqua, round, shallow, biconvex tablet, scored on one side and debossed with “N 404” on the other side.

NDC 70954-404-10: Bottle of 100 Tablets

Store and Dispense

Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Dispense in a tight light- resistant, child-resistant container as defined in the USP/NF.

All trademarks are the property of their respective owners.

Manufactured by:

Novitium Pharma LLC

70 Lake Drive, East Windsor

New Jersey 08520

Issued: 04/2023

LB4336-01

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dexamethasone Tablets, USP 1.5 mg

NDC 70954-401-10: Bottle of 100 Tablets

Dexamethasone Tablets, USP 2 mg

NDC 70954-402-10: Bottle of 100 Tablets

Dexamethasone Tablets, USP 4 mg

NDC 70954-403-10: Bottle of 100 Tablets

NDC 70954-403-30: Unit dose blister packages of 100 (10 cards of 10 tablets each)

Dexamethasone Tablets, USP 6 mg

NDC 70954-404-10: Bottle of 100 Tablets

DEXAMETHASONE dexamethasone tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70954-401 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXAMETHASONE (DEXAMETHASONE) DEXAMETHASONE 1.5 mg

Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE ANHYDROUS LACTOSE CROSCARMELLOSE SODIUM MAGNESIUM STEARATE D&C RED NO. 27 FD&C RED NO. 40 D&C YELLOW NO. 10

Product Characteristics Color PINK Score 2 pieces Shape ROUND Size 6mm Flavor Imprint Code N401 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:70954-401-10 100 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA215604 08/08/2022

DEXAMETHASONE dexamethasone tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70954-403 Route of Administration ORAL DEA Schedule

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

Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE ANHYDROUS LACTOSE CROSCARMELLOSE SODIUM MAGNESIUM STEARATE FD&C YELLOW NO. 5 FD&C BLUE NO. 1

Product Characteristics Color GREEN Score 2 pieces Shape ROUND Size 6mm Flavor Imprint Code N403 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:70954-403-10 100 TABLET in 1 BOTTLE None 2 NDC:70954-403-30 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK (70954-403-20) 2 NDC:70954-403-20 1 TABLET in 1 BLISTER PACK This package is contained within the CARTON (70954-403-30)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA215604 08/08/2022

DEXAMETHASONE dexamethasone tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70954-404 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXAMETHASONE (DEXAMETHASONE) DEXAMETHASONE 6 mg

Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE ANHYDROUS LACTOSE CROSCARMELLOSE SODIUM MAGNESIUM STEARATE FD&C BLUE NO. 1 D&C YELLOW NO. 10

Product Characteristics Color BLUE (Aqua) Score 2 pieces Shape ROUND Size 6mm Flavor Imprint Code N404 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:70954-404-10 100 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA215604 08/08/2022

DEXAMETHASONE dexamethasone tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70954-402 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXAMETHASONE (DEXAMETHASONE) DEXAMETHASONE 2 mg

Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE ANHYDROUS LACTOSE CROSCARMELLOSE SODIUM MAGNESIUM STEARATE

Product Characteristics Color WHITE (White to off-white) Score 2 pieces Shape ROUND Size 6mm Flavor Imprint Code N402 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:70954-402-10 100 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA217696 05/09/2023

Labeler — ANI Pharmaceuticals, Inc. (145588013)

Establishment
Name	Address	ID/FEI	Operations
Novitium Pharma LLC		080301870	ANALYSIS (70954-401), ANALYSIS (70954-402), ANALYSIS (70954-403), ANALYSIS (70954-404), LABEL (70954-401), LABEL (70954-402), LABEL (70954-403), LABEL (70954-404), MANUFACTURE (70954-401), MANUFACTURE (70954-402), MANUFACTURE (70954-403), MANUFACTURE (70954-404), PACK (70954-401), PACK (70954-402), PACK (70954-403), PACK (70954-404)

Revised: 05/2023 ANI Pharmaceuticals, Inc.