Qsymia (Page 9 of 9)

PRINCIPAL DISPLAY PANEL — 7.5 mg/46 mg Capsule Bottle Label

NDC NUMBER 62541-202-30

Qsymia ®
(phentermine and topiramate extended-release) capsules CIV

7.5 mg/46 mg

30 Capsules

Rx only

DISPENSE WITH MEDICATION GUIDE

PRINCIPAL DISPLAY PANEL -- 7.5 mg/46 mg Capsule Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 3.75 mg/23 mg Capsule Bottle Label

NDC NUMBER 62541-201-30

Qsymia ®
(phentermine and topiramate extended-release) capsules CIV

3.75 mg/23 mg

30 Capsules

Rx only

DISPENSE WITH MEDICATION GUIDE

PRINCIPAL DISPLAY PANEL -- 3.75 mg/23 mg Capsule Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 15 mg/92 mg Capsule Bottle Label

NDC NUMBER 62541-204-30

Qsymia ®
(phentermine and topiramate extended-release) capsules CIV

15 mg/92 mg

30 Capsules

Rx only

DISPENSE WITH MEDICATION GUIDE

PRINCIPAL DISPLAY PANEL -- 15 mg/92 mg Capsule Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 11.25 mg/69 mg Capsule Bottle Label

NDC NUMBER 62541-203-30

Qsymia ®
(phentermine and topiramate extended-release) capsules CIV

11.25 mg/69 mg

30 Capsules

Rx only

DISPENSE WITH MEDICATION GUIDE

PRINCIPAL DISPLAY PANEL -- 11.25 mg/69 mg Capsule Bottle Label
(click image for full-size original)
QSYMIA phentermine and topiramate capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62541-202
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHENTERMINE HYDROCHLORIDE (PHENTERMINE) PHENTERMINE 7.5 mg
TOPIRAMATE (TOPIRAMATE) TOPIRAMATE 46 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
ETHYLCELLULOSE, UNSPECIFIED
POVIDONE K30
GELATIN, UNSPECIFIED
TALC
TITANIUM DIOXIDE
FD&C BLUE NO. 1
FD&C RED NO. 3
FD&C YELLOW NO. 5
FD&C YELLOW NO. 6
SUCROSE
STARCH, CORN
Product Characteristics
Color purple, yellow Score no score
Shape CAPSULE Size 12mm
Flavor Imprint Code VIVUS;75;46
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62541-202-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, UNIT-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022580 09/17/2012
QSYMIA phentermine and topiramate capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62541-201
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHENTERMINE HYDROCHLORIDE (PHENTERMINE) PHENTERMINE 3.75 mg
TOPIRAMATE (TOPIRAMATE) TOPIRAMATE 23 mg
Inactive Ingredients
Ingredient Name Strength
SUCROSE
STARCH, CORN
MICROCRYSTALLINE CELLULOSE
ETHYLCELLULOSE, UNSPECIFIED
POVIDONE K30
GELATIN, UNSPECIFIED
TALC
TITANIUM DIOXIDE
FD&C BLUE NO. 1
FD&C RED NO. 3
Product Characteristics
Color purple Score no score
Shape CAPSULE Size 12mm
Flavor Imprint Code VIVUS;375;23
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62541-201-14 14 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, UNIT-DOSE None
2 NDC:62541-201-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, UNIT-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022580 09/17/2012
QSYMIA phentermine and topiramate capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62541-204
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHENTERMINE HYDROCHLORIDE (PHENTERMINE) PHENTERMINE 15 mg
TOPIRAMATE (TOPIRAMATE) TOPIRAMATE 92 mg
Inactive Ingredients
Ingredient Name Strength
SUCROSE
STARCH, CORN
MICROCRYSTALLINE CELLULOSE
ETHYLCELLULOSE, UNSPECIFIED
POVIDONE K30
GELATIN, UNSPECIFIED
TALC
TITANIUM DIOXIDE
FD&C YELLOW NO. 5
FD&C YELLOW NO. 6
Product Characteristics
Color yellow, white Score no score
Shape CAPSULE Size 12mm
Flavor Imprint Code VIVUS;15;92
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62541-204-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, UNIT-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022580 09/17/2012
QSYMIA phentermine and topiramate capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62541-203
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHENTERMINE HYDROCHLORIDE (PHENTERMINE) PHENTERMINE 11.25 mg
TOPIRAMATE (TOPIRAMATE) TOPIRAMATE 69 mg
Inactive Ingredients
Ingredient Name Strength
SUCROSE
STARCH, CORN
MICROCRYSTALLINE CELLULOSE
ETHYLCELLULOSE, UNSPECIFIED
POVIDONE K30
GELATIN, UNSPECIFIED
TALC
TITANIUM DIOXIDE
FD&C YELLOW NO. 5
FD&C YELLOW NO. 6
Product Characteristics
Color yellow Score no score
Shape CAPSULE Size 12mm
Flavor Imprint Code VIVUS;1125;69
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62541-203-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022580 09/17/2012
Labeler — Vivus LLC (782772263)

Revised: 04/2022 Vivus LLC

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