Tegretol (Page 8 of 8)

PRINCIPAL DISPLAY PANEL

NDC 0078-0509-05

Rx only

Tegretol® 200 mg

carbamazepine USP

100 tablets

PHARMACIST: Dispense with Medication Guideattached or provided separately.

NOVARTIS

PRINCIPAL DISPLAY PANEL
							NDC 0078-0509-05
							Rx only
							Tegretol® 200 mg
							carbamazepine USP
							100 tablets
							PHARMACIST: Dispense with Medication Guide 
							attached or provided separately.
							NOVARTIS
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 0078-0510-05

Rx only

Tegretol® -XR 100 mg

(carbamazepine extended-release tablets)

Tegretol-XR tablets must be swallowed
whole and never crushed or chewed.

100 tablets

PHARMACIST: Dispense with Medication Guideattached or provided separately.

NOVARTIS

PRINCIPAL DISPLAY PANEL
							NDC 0078-0510-05
							Rx only		
							Tegretol®-XR 100 mg
							(carbamazepine extended-release tablets)
							Tegretol-XR tablets must be swallowed
							whole and never crushed or chewed.
							100 tablets
							PHARMACIST: Dispense with Medication Guide 
							attached or provided separately.
							NOVARTIS
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 0078-0511-05

Rx only

Tegretol® -XR 200 mg

(carbamazepine extended-release tablets)

Tegretol-XR tablets must be swallowed
whole and never crushed or chewed.

100 tablets

PHARMACIST: Dispense with Medication Guideattached or provided separately.

NOVARTIS

PRINCIPAL DISPLAY PANEL
							NDC 0078-0511-05
							Rx only		
							Tegretol®-XR 200 mg
							(carbamazepine extended-release tablets)
							Tegretol-XR tablets must be swallowed
							whole and never crushed or chewed.
							100 tablets
							PHARMACIST: Dispense with Medication Guide 
							attached or provided separately.
							NOVARTIS
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 0078-0512-05

Rx only

Tegretol® -XR 400 mg

(carbamazepine extended-release tablets)

Tegretol-XR tablets must be swallowed
whole and never crushed or chewed.

100 tablets

PHARMACIST: Dispense with Medication Guideattached or provided separately.

NOVARTIS

PRINCIPAL DISPLAY PANEL
							NDC 0078-0512-05
							Rx only		
							Tegretol®-XR 400 mg
							(carbamazepine extended-release tablets)
							Tegretol-XR tablets must be swallowed
							whole and never crushed or chewed.
							100 tablets
							PHARMACIST: Dispense with Medication Guide 
							attached or provided separately.
							NOVARTIS
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 0078-0508-83

Tegretol®
(carbamazepine USP)
Suspension

100 mg/5 mL

IMPORTANT: Shake well before using.

Each 5 mL contains 100 mg carbamazepine USP.

450 mL

Dispense in tight, light-resistant
container (USP).

PHARMACIST: Dispense with
Medication Guide attached orprovided separately.

Rx only

NOVARTIS

PRINCIPAL DISPLAY PANEL
							NDC 0078-0508-83
							Tegretol®
							(carbamazepine USP)Suspension
							100 mg/5 mL
							IMPORTANT: Shake well before using.
							Each 5 mL contains 100 mg carbamazepine USP.
							450 mL
							Dispense in tight, light-resistant
							container (USP).
							PHARMACIST: Dispense with
							Medication Guide attached or
							provided separately.
							Rx only
							NOVARTIS
(click image for full-size original)

TEGRETOL carbamazepine suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0078-0508
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARBAMAZEPINE (CARBAMAZEPINE) CARBAMAZEPINE 100 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE
FD&C YELLOW NO. 6
POTASSIUM SORBATE
PROPYLENE GLYCOL
WATER
SORBITOL
SUCROSE
XANTHAN GUM
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0078-0508-83 450 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018927 12/18/1987
TEGRETOL carbamazepine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0078-0509
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARBAMAZEPINE (CARBAMAZEPINE) CARBAMAZEPINE 200 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
FD&C RED NO. 40
GELATIN
GLYCERIN
MAGNESIUM STEARATE
STEARIC ACID
Product Characteristics
Color PINK Score 2 pieces
Shape CAPSULE (capsule shaped) Size 14mm
Flavor Imprint Code Tegretol;27;27
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0078-0509-05 100 TABLET in 1 BOTTLE None
2 NDC:0078-0509-20 60 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA016608 03/11/1968
TEGRETOL XR carbamazepine tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0078-0510
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARBAMAZEPINE (CARBAMAZEPINE) CARBAMAZEPINE 100 mg
Inactive Ingredients
Ingredient Name Strength
DEXTRATES
MAGNESIUM STEARATE
MANNITOL
POLYETHYLENE GLYCOL
SODIUM LAURYL SULFATE
Product Characteristics
Color YELLOW Score no score
Shape ROUND Size 8mm
Flavor Imprint Code T;100;mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0078-0510-05 100 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020234 03/25/1996
TEGRETOL XR carbamazepine tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0078-0511
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARBAMAZEPINE (CARBAMAZEPINE) CARBAMAZEPINE 200 mg
Inactive Ingredients
Ingredient Name Strength
DEXTRATES
MAGNESIUM STEARATE
MANNITOL
POLYETHYLENE GLYCOL
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
Product Characteristics
Color PINK Score no score
Shape ROUND Size 10mm
Flavor Imprint Code T;200;mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0078-0511-05 100 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020234 03/25/1996
TEGRETOL XR carbamazepine tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0078-0512
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARBAMAZEPINE (CARBAMAZEPINE) CARBAMAZEPINE 400 mg
Inactive Ingredients
Ingredient Name Strength
DEXTRATES
MAGNESIUM STEARATE
MANNITOL
POLYETHYLENE GLYCOL
SODIUM LAURYL SULFATE
Product Characteristics
Color BROWN Score no score
Shape ROUND Size 12mm
Flavor Imprint Code T;400;mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0078-0512-05 100 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020234 03/25/1996
Labeler — Novartis Pharmaceuticals Corporation (002147023)

Revised: 07/2021 Novartis Pharmaceuticals Corporation

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