Prescription Drug Information: FIRVANQ (Page 4 of 4)

PRINCIPAL DISPLAY PANEL

NDC 65628-016-05
FIRVANQ
(vancomycin hydrochloride) for oral solution
For Oral Use Only
Vancomycin Hydrochloride Powder for Oral Solution Kit
Vancomycin 50 mg/mL in Grape Flavored Diluent
EACH KIT INCLUDES:
• 1 bottle containing Vancomycin Hydrochloride USP,
powder for oral solution, equivalent to 7.5 g Vancomycin
• 1 bottle containing 145 mL Grape Flavored Diluent
for reconstitution
When r econstituted, each mL contains 5 0 mg Vancomycin
Must be Refrigerated
150 mL
final volume after reconstitution Rx Only

Firvanq 50mg/ml 150 mL
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 65628-016-10
FIRVANQ
(vancomycin hydrochloride) for oral solution
For Oral Use Only
Vancomycin Hydrochloride Powder for Oral Solution Kit
Vancomycin 50 mg/mL in Grape Flavored Diluent
EACH KIT INCLUDES:
• 1 bottle containing Vancomycin Hydrochloride USP,
powder for oral solution, equivalent to 15 g Vancomycin
• 1 bottle containing 289 mL Grape Flavored Diluent
for reconstitution
When r econstituted, each mL contains 5 0 mg Vancomycin
Must be Refrigerated
300 mL
final volume after reconstitution Rx Only

Firvanq 50 mg/ml 300 mL
(click image for full-size original)

FIRVANQ vancomycin hydrochloride kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65628-015
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65628-015-05 1 KIT in 1 CARTON None
2 NDC:65628-015-10 1 KIT in 1 CARTON None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 BOTTLE 295 mL
Part 2 1 BOTTLE 3.75 g
Part 3 1 BOTTLE 147 mL
Part 4 1 BOTTLE 7.5 g
Part 1 of 4
GRAPE FLAVORED DILUENT grape flavored diluent solution
Product Information
Route of Administration ORAL DEA Schedule
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID
D&C YELLOW NO. 10
FD&C RED NO. 40
WATER
SODIUM BENZOATE
SUCRALOSE
Product Characteristics
Color Score
Shape Size
Flavor GRAPE Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 295 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA208910 01/26/2018
Part 2 of 4
VANCOMYCIN HYDROCHLORIDE vancomycin hydrochloride powder, for solution
Product Information
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VANCOMYCIN HYDROCHLORIDE (VANCOMYCIN) VANCOMYCIN 1 g in 1 g
Product Characteristics
Color white (white to almost white or tan to brown) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 3.75 g in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA208910 01/26/2018
Part 3 of 4
GRAPE FLAVORED DILUENT grape flavored diluent solution
Product Information
Route of Administration ORAL DEA Schedule
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID
D&C YELLOW NO. 10
FD&C RED NO. 40
WATER
SODIUM BENZOATE
SUCRALOSE
Product Characteristics
Color Score
Shape Size
Flavor GRAPE Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 147 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA208910 01/26/2018
Part 4 of 4
VANCOMYCIN HYDROCHLORIDE vancomycin hydrochloride powder, for solution
Product Information
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VANCOMYCIN HYDROCHLORIDE (VANCOMYCIN) VANCOMYCIN 1 g in 1 g
Product Characteristics
Color white (white to almost white or tan to brown) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 7.5 g in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA208910 01/26/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA208910 01/26/2018
FIRVANQ vancomycin hydrochloride kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65628-016
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65628-016-05 1 KIT in 1 CARTON None
2 NDC:65628-016-10 1 KIT in 1 CARTON None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 BOTTLE 289 mL
Part 2 1 BOTTLE 7.5 g
Part 3 1 BOTTLE 145 mL
Part 4 1 BOTTLE 15 g
Part 1 of 4
GRAPE FLAVORED DILUENT grape flavored diluent solution
Product Information
Route of Administration ORAL DEA Schedule
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID
D&C YELLOW NO. 10
FD&C RED NO. 40
WATER
SODIUM BENZOATE
SUCRALOSE
Product Characteristics
Color Score
Shape Size
Flavor GRAPE Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 289 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA208910 01/26/2018
Part 2 of 4
VANCOMYCIN HYDROCHLORIDE vancomycin hydrochloride powder, for solution
Product Information
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VANCOMYCIN HYDROCHLORIDE (VANCOMYCIN) VANCOMYCIN 1 g in 1 g
Product Characteristics
Color white Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 7.5 g in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA208910 01/26/2018
Part 3 of 4
GRAPE FLAVORED DILUENT grape flavored diluent solution
Product Information
Route of Administration ORAL DEA Schedule
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID
D&C YELLOW NO. 10
FD&C RED NO. 40
WATER
SODIUM BENZOATE
SUCRALOSE
Product Characteristics
Color Score
Shape Size
Flavor GRAPE Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 145 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA208910 01/26/2018
Part 4 of 4
VANCOMYCIN HYDROCHLORIDE vancomycin hydrochloride powder, for solution
Product Information
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VANCOMYCIN HYDROCHLORIDE (VANCOMYCIN) VANCOMYCIN 1 g in 1 g
Product Characteristics
Color white Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 15 g in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA208910 01/26/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA208910 01/26/2018
Labeler — CutisPharma, Inc. (090598256)

Revised: 10/2020 CutisPharma, Inc.

Page 4 of 4 1 2 3 4

RxDrugLabels.com provides trustworthy package insert and label information about marketed prescription drugs as submitted by manufacturers to the U.S. Food and Drug Administration. Package information is not reviewed or updated separately by RxDrugLabels.com. Every individual prescription drug label and package insert entry contains a unique identifier which can be used to secure further details directly from the U.S. National Institutes of Health and/or the FDA.

Medication Sections

Medication Information by RSS

As a leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. RxDrugLabels.com provides the full prescription-only subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2020. All Rights Reserved.