NDC Code(s) : 52817-820-50, 52817-821-50, 52817-822-50
Packager : TRUPHARMA, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Metformin Hydrochloride Oral SolutionMetformin Hydrochloride SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52817-820
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METFORMIN HYDROCHLORIDE(UNII: 786Z46389E)
(METFORMIN - UNII:9100L32L2N) 		METFORMIN HYDROCHLORIDE500 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
BENZOIC ACID(UNII: 8SKN0B0MIM)
HYDROCHLORIC ACID(UNII: QTT17582CB)
POTASSIUM BICARBONATE(UNII: HM5Z15LEBN)
WATER(UNII: 059QF0KO0R)
SUCRALOSE(UNII: 96K6UQ3ZD4)
XANTHAN GUM(UNII: TTV12P4NEE)
Product Characteristics
Color Score
Shape Size
Flavor STRAWBERRY Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:52817-820-505 in 1 CASE 25/01/2022
110 in 1 TRAY
15 mL in 1 CUP, UNIT-DOSE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211309 01/25/2022
Metformin Hydrochloride Oral SolutionMetformin Hydrochloride SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52817-821
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METFORMIN HYDROCHLORIDE(UNII: 786Z46389E)
(METFORMIN - UNII:9100L32L2N) 		METFORMIN HYDROCHLORIDE500 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
BENZOIC ACID(UNII: 8SKN0B0MIM)
HYDROCHLORIC ACID(UNII: QTT17582CB)
POTASSIUM BICARBONATE(UNII: HM5Z15LEBN)
WATER(UNII: 059QF0KO0R)
SUCRALOSE(UNII: 96K6UQ3ZD4)
XANTHAN GUM(UNII: TTV12P4NEE)
Product Characteristics
Color Score
Shape Size
Flavor STRAWBERRY Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:52817-821-505 in 1 CASE 25/01/2022
110 in 1 TRAY
18.5 mL in 1 CUP, UNIT-DOSE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211309 01/25/2022
Metformin Hydrochloride Oral SolutionMetformin Hydrochloride SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52817-822
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METFORMIN HYDROCHLORIDE(UNII: 786Z46389E)
(METFORMIN - UNII:9100L32L2N) 		METFORMIN HYDROCHLORIDE500 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
BENZOIC ACID(UNII: 8SKN0B0MIM)
HYDROCHLORIC ACID(UNII: QTT17582CB)
POTASSIUM BICARBONATE(UNII: HM5Z15LEBN)
WATER(UNII: 059QF0KO0R)
SUCRALOSE(UNII: 96K6UQ3ZD4)
XANTHAN GUM(UNII: TTV12P4NEE)
Product Characteristics
Color Score
Shape Size
Flavor STRAWBERRY Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:52817-822-505 in 1 CASE 25/01/2022
110 in 1 TRAY
110 mL in 1 CUP, UNIT-DOSE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211309 01/25/2022

LABELER - TRUPHARMA, LLC(078533947)

REGISTRANT - Saptalis Pharmaceuticals, LLC(080145868)

Establishment
Name Address ID/FEI Business Operations
Saptalis Pharmaceuticals, LLC 081154447 MANUFACTURE(52817-820), manufacture(52817-821, 52817-822)

PRINCIPAL DISPLAY PANEL

52817-820-05

Metformin Hydrochloride Oral Solution

500 mg/5 mL

Unit dose delivers 5 mL

Strawberry Flavor

500 mg/5 mL Cup label

PRINCIPAL DISPLAY PANEL

NDC 52817-820-50

Metformin Hydrochloride Oral Solution

500 mg/5 mL per Cup

Unit-dose delivers 5 mL

Strawberry Flavor

Rx only

5 Trays contain 50 Unit-dose Cups,

Each Cup has 5 mL Fill

500 mg/5 mL Box label

PRINCIPAL DISPLAY PANEL

52817-821-85
Metformin Hydrochloride Oral Solution, 500 mg/5 mL

850 mg/8.5 mL

Unit dose delivers 8.5 mL

Strawberry Flavor

850 mg/8.5 mL Cuplabel

PRINCIPAL DISPLAY PANEL

NDC 52817-821-50

Metformin Hydrochloride Oral Solution, 500 mg/5mL

850 mg/8.5 mL per Cup

Unit-dose delivers 8.5 mL

Strawberry Flavor

Rx only

5 Trays contain 50 Unit-dose Cups,

Each Cup has 8.5 mL Fill

850 mg/8.5 mL Box label