SPL UNCLASSIFIED

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1704-1

Dexamethasone Tablets, USP 0.5 mg

100 Tablets

Rx only

Zydus

NDC 70771-1705-1

Dexamethasone Tablets, USP 0.75 mg

100 Tablets

Rx only

Zydus

NDC 70771-1707-1

Dexamethasone Tablets, USP 1.5 mg

100 Tablets

Rx only

Zydus

NDC 70771-1699-1

Dexamethasone Tablets, USP 4 mg

100 Tablets

Rx only

Zydus

NDC 70771-1700-1

Dexamethasone Tablets, USP 6 mg

100 Tablets

Rx only

Zydus

DEXAMETHASONE
dexamethasone tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1699
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DEXAMETHASONE (UNII: 7S5I7G3JQL) (DEXAMETHASONE - UNII:7S5I7G3JQL)	DEXAMETHASONE	4 mg

Ingredient Name	Strength
Inactive Ingredients
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STARCH, CORN (UNII: O8232NY3SJ)
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	GREEN (off-white to light green)	Score	2 pieces
Shape	ROUND	Size	6mm
Flavor		Imprint Code	1736
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70771-1699-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	04/15/2024

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA216282	04/15/2024

DEXAMETHASONE
dexamethasone tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1700
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DEXAMETHASONE (UNII: 7S5I7G3JQL) (DEXAMETHASONE - UNII:7S5I7G3JQL)	DEXAMETHASONE	6 mg

Ingredient Name	Strength
Inactive Ingredients
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STARCH, CORN (UNII: O8232NY3SJ)
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	BLUE (off-white to light blue)	Score	2 pieces
Shape	ROUND	Size	6mm
Flavor		Imprint Code	1737
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70771-1700-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	04/15/2024

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA216282	04/15/2024

DEXAMETHASONE
dexamethasone tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1704
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DEXAMETHASONE (UNII: 7S5I7G3JQL) (DEXAMETHASONE - UNII:7S5I7G3JQL)	DEXAMETHASONE	0.5 mg

Ingredient Name	Strength
Inactive Ingredients
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STARCH, CORN (UNII: O8232NY3SJ)
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	YELLOW (light yellow to yellow)	Score	2 pieces
Shape	OVAL	Size	6mm
Flavor		Imprint Code	1791
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70771-1704-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	04/15/2024

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA216282	04/15/2024

DEXAMETHASONE
dexamethasone tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1705
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DEXAMETHASONE (UNII: 7S5I7G3JQL) (DEXAMETHASONE - UNII:7S5I7G3JQL)	DEXAMETHASONE	0.75 mg

Ingredient Name	Strength
Inactive Ingredients
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STARCH, CORN (UNII: O8232NY3SJ)
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	GRAY (off-white to grey)	Score	2 pieces
Shape	OVAL	Size	7mm
Flavor		Imprint Code	1792
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70771-1705-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	04/15/2024

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA216282	04/15/2024

DEXAMETHASONE
dexamethasone tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1707
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DEXAMETHASONE (UNII: 7S5I7G3JQL) (DEXAMETHASONE - UNII:7S5I7G3JQL)	DEXAMETHASONE	1.5 mg

Ingredient Name	Strength
Inactive Ingredients
ALUMINUM OXIDE (UNII: LMI26O6933)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FERRIC OXIDE RED (UNII: 1K09F3G675)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STARCH, CORN (UNII: O8232NY3SJ)
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	PINK (light-pink to pink)	Score	2 pieces
Shape	ROUND	Size	6mm
Flavor		Imprint Code	1795
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70771-1707-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	04/15/2024

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA216282	04/15/2024

Labeler - Zydus Lifesciences Limited (918596198)

Name	Address	ID/FEI	Business Operations
Establishment
Zydus Lifesciences Limited		677605858	ANALYSIS(70771-1704, 70771-1705, 70771-1707, 70771-1699, 70771-1700) , MANUFACTURE(70771-1704, 70771-1705, 70771-1707, 70771-1699, 70771-1700)