Dexamethasone by Zydus Lifesciences Limited DEXAMETHASONE tablet

Dexamethasone by

Drug Labeling and Warnings

Dexamethasone by is a Prescription medication manufactured, distributed, or labeled by Zydus Lifesciences Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 70771-1701-1

Dexamethasone Tablets, USP 2 mg

100 Tablets

Rx only

Zydus

INGREDIENTS AND APPEARANCE

DEXAMETHASONE 
dexamethasone tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1701
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXAMETHASONE (UNII: 7S5I7G3JQL) (DEXAMETHASONE - UNII:7S5I7G3JQL)	DEXAMETHASONE	2 mg

Inactive Ingredients
Ingredient Name	Strength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STARCH, CORN (UNII: O8232NY3SJ)
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	WHITE (white to off-white)	Score	2 pieces
Shape	ROUND	Size	6mm
Flavor		Imprint Code	1735
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1701-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	04/15/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA216283	04/15/2024

Labeler - Zydus Lifesciences Limited (918596198)

Establishment
Name	Address	ID/FEI	Business Operations
Zydus Lifesciences Limited		677605858	ANALYSIS(70771-1701) , MANUFACTURE(70771-1701)