FENTORA (Page 14 of 14)

Package/Label Display Panel

28 Buccal Tablets (4 tablets X 7 cards)

NDC 63459-546-28

FENTORA® CII

(fentanyl buccal tablet)

equivalent to 600 mcg fentanyl base

Information for Pharmacist:

  • Counsel the patient about the use of this product including maximum dosing during a single breakthrough pain episode
  • Instruct patients to read the enclosed FENTORA Medication Guide
  • FENTORA must only be supplied through the TIRF REMS Access restricted program. For more information call 1-866-822-1483 or visit www.TIRFREMSAccess.com.

WARNING: Keep out of the reach of children

PATIENTS MUST BE TOLERANT TO AROUND-THE-CLOCK OPIOID THERAPY

DO NOT SUBSTITUTE FENTORA FOR OTHER FENTANYL PRODUCTS

FENTORA can be harmful or fatal if given to someone for whom it was not prescribed

For Buccal or Sublingual Administration.

Do NOT Split, Crush, Suck, Chew, or Swallow Tablet.

image
(click image for full-size original)

Package/Label Display Panel

28 Buccal Tablets (4 tablets X 7 cards)

NDC 63459-548-28

FENTORA® CII

(fentanyl buccal tablet)

equivalent to 800 mcg fentanyl base

Information for Pharmacist:

  • Counsel the patient about the use of this product including maximum dosing during a single breakthrough pain episode
  • Instruct patients to read the enclosed FENTORA Medication Guide
  • FENTORA must only be supplied through the TIRF REMS Access restricted program. For more information call 1-866-822-1483 or visit www.TIRFREMSAccess.com.

WARNING: Keep out of the reach of children

PATIENTS MUST BE TOLERANT TO AROUND-THE-CLOCK OPIOID THERAPY

DO NOT SUBSTITUTE FENTORA FOR OTHER FENTANYL PRODUCTS

FENTORA can be harmful or fatal if given to someone for whom it was not prescribed

For Buccal or Sublingual Administration.

Do NOT Split, Crush, Suck, Chew, or Swallow Tablet.

image
(click image for full-size original)
FENTORA
fentanyl tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63459-541
Route of Administration BUCCAL, SUBLINGUAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FENTANYL CITRATE (FENTANYL) FENTANYL 100 ug
Inactive Ingredients
Ingredient Name Strength
MANNITOL
SODIUM STARCH GLYCOLATE TYPE A POTATO
SODIUM BICARBONATE
SODIUM CARBONATE
ANHYDROUS CITRIC ACID
MAGNESIUM STEARATE
Product Characteristics
Color white Score no score
Shape ROUND Size 6mm
Flavor Imprint Code 1;C
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63459-541-28 28 BLISTER PACK in 1 CARTON contains a BLISTER PACK (63459-541-04)
1 NDC:63459-541-04 1 TABLET in 1 BLISTER PACK This package is contained within the CARTON (63459-541-28)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021947 10/02/2006
FENTORA
fentanyl tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63459-542
Route of Administration BUCCAL, SUBLINGUAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FENTANYL CITRATE (FENTANYL) FENTANYL 200 ug
Inactive Ingredients
Ingredient Name Strength
MANNITOL
SODIUM STARCH GLYCOLATE TYPE A POTATO
SODIUM BICARBONATE
SODIUM CARBONATE
ANHYDROUS CITRIC ACID
MAGNESIUM STEARATE
Product Characteristics
Color white Score no score
Shape ROUND Size 8mm
Flavor Imprint Code 2;C
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63459-542-28 28 BLISTER PACK in 1 CARTON contains a BLISTER PACK (63459-542-04)
1 NDC:63459-542-04 1 TABLET in 1 BLISTER PACK This package is contained within the CARTON (63459-542-28)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021947 10/02/2006
FENTORA
fentanyl tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63459-544
Route of Administration BUCCAL, SUBLINGUAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FENTANYL CITRATE (FENTANYL) FENTANYL 400 ug
Inactive Ingredients
Ingredient Name Strength
MANNITOL
SODIUM STARCH GLYCOLATE TYPE A POTATO
SODIUM BICARBONATE
SODIUM CARBONATE
ANHYDROUS CITRIC ACID
MAGNESIUM STEARATE
Product Characteristics
Color white Score no score
Shape ROUND Size 8mm
Flavor Imprint Code 4;C
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63459-544-28 28 BLISTER PACK in 1 CARTON contains a BLISTER PACK (63459-544-04)
1 NDC:63459-544-04 1 TABLET in 1 BLISTER PACK This package is contained within the CARTON (63459-544-28)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021947 10/02/2006
FENTORA
fentanyl tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63459-546
Route of Administration BUCCAL, SUBLINGUAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FENTANYL CITRATE (FENTANYL) FENTANYL 600 ug
Inactive Ingredients
Ingredient Name Strength
MANNITOL
SODIUM STARCH GLYCOLATE TYPE A POTATO
SODIUM BICARBONATE
SODIUM CARBONATE
ANHYDROUS CITRIC ACID
MAGNESIUM STEARATE
Product Characteristics
Color white Score no score
Shape ROUND Size 8mm
Flavor Imprint Code 6;C
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63459-546-28 28 BLISTER PACK in 1 CARTON contains a BLISTER PACK (63459-546-04)
1 NDC:63459-546-04 1 TABLET in 1 BLISTER PACK This package is contained within the CARTON (63459-546-28)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021947 10/02/2006
FENTORA
fentanyl tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63459-548
Route of Administration BUCCAL, SUBLINGUAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FENTANYL CITRATE (FENTANYL) FENTANYL 800 ug
Inactive Ingredients
Ingredient Name Strength
MANNITOL
SODIUM STARCH GLYCOLATE TYPE A POTATO
SODIUM BICARBONATE
SODIUM CARBONATE
ANHYDROUS CITRIC ACID
MAGNESIUM STEARATE
Product Characteristics
Color white Score no score
Shape ROUND Size 8mm
Flavor Imprint Code 8;C
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63459-548-28 28 BLISTER PACK in 1 CARTON contains a BLISTER PACK (63459-548-04)
1 NDC:63459-548-04 1 TABLET in 1 BLISTER PACK This package is contained within the CARTON (63459-548-28)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021947 10/02/2006
Labeler — Cephalon, LLC (183236314)

Revised: 11/2022 Cephalon, LLC

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