ELTROMBOPAG by Zydus Lifesciences Limited ELTROMBOPAG tablet

ELTROMBOPAG by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

MEDICATION GUIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 70771-1925-3

Eltrombopag Tablets, 12.5 mg

30 Tablets

Rx only

NDC: 70771-1926-3

Eltrombopag Tablets, 25 mg

30 Tablets

Rx only

NDC: 70771-1927-3

Eltrombopag Tablets, 50 mg

30 Tablets

Rx only

NDC: 70771-1928-3

Eltrombopag Tablets, 75 mg

30 Tablets

Rx only

INGREDIENTS AND APPEARANCE

ELTROMBOPAG 
eltrombopag tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1925
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ELTROMBOPAG OLAMINE (UNII: 4U07F515LG) (ELTROMBOPAG - UNII:S56D65XJ9G)	ELTROMBOPAG	12.5 mg

Inactive Ingredients
Ingredient Name	Strength
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POVIDONE K30 (UNII: U725QWY32X)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
XYLITOL (UNII: VCQ006KQ1E)

Product Characteristics
Color	WHITE (white to light blue)	Score	no score
Shape	ROUND	Size	5mm
Flavor		Imprint Code	I
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1925-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	01/14/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA216281	01/14/2026

ELTROMBOPAG 
eltrombopag tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1926
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ELTROMBOPAG OLAMINE (UNII: 4U07F515LG) (ELTROMBOPAG - UNII:S56D65XJ9G)	ELTROMBOPAG	25 mg

Inactive Ingredients
Ingredient Name	Strength
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POVIDONE K30 (UNII: U725QWY32X)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
XYLITOL (UNII: VCQ006KQ1E)

Product Characteristics
Color	YELLOW (light yellow)	Score	no score
Shape	ROUND	Size	7mm
Flavor		Imprint Code	I7
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1926-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	01/14/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA216281	01/14/2026

ELTROMBOPAG 
eltrombopag tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1927
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ELTROMBOPAG OLAMINE (UNII: 4U07F515LG) (ELTROMBOPAG - UNII:S56D65XJ9G)	ELTROMBOPAG	50 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 2--ALUMINUM LAKE (UNII: 4AQJ3LG584)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POVIDONE K30 (UNII: U725QWY32X)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
XYLITOL (UNII: VCQ006KQ1E)

Product Characteristics
Color	BLUE (light blue)	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code	112
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1927-7	14 in 1 BOTTLE; Type 0: Not a Combination Product	01/14/2026
2	NDC: 70771-1927-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	01/14/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA216281	01/14/2026

ELTROMBOPAG 
eltrombopag tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1928
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ELTROMBOPAG OLAMINE (UNII: 4U07F515LG) (ELTROMBOPAG - UNII:S56D65XJ9G)	ELTROMBOPAG	75 mg

Inactive Ingredients
Ingredient Name	Strength
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POVIDONE K30 (UNII: U725QWY32X)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
XYLITOL (UNII: VCQ006KQ1E)

Product Characteristics
Color	PURPLE (light purple)	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	I17
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1928-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	01/14/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA216281	01/14/2026

Labeler - Zydus Lifesciences Limited (918596198)

Establishment
Name	Address	ID/FEI	Business Operations
Zydus Lifesciences Limited		863362789	ANALYSIS(70771-1925, 70771-1926, 70771-1927, 70771-1928) , MANUFACTURE(70771-1925, 70771-1926, 70771-1927, 70771-1928)