NDC Code(s) : 55154-4513-6, 55154-4513-3, 55154-4513-0, 55154-4518-6, 55154-4518-4, 55154-4518-0
Packager : Cardinal Health

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

AVANDIArosiglitazone maleate TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55154-4513(NDC:0029-3159)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ROSIGLITAZONE MALEATE(UNII: KX2339DP44)
(ROSIGLITAZONE - UNII:05V02F2KDG) 		ROSIGLITAZONE MALEATE4 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSE 2910 (3 MPA.S)(UNII: 0VUT3PMY82)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 3000(UNII: SA1B764746)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)
TALC(UNII: 7SEV7J4R1U)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
Color ORANGE Score no score
Shape FREEFORM (pentagonal) Size 10 mm
Flavor Imprint Code SB;4
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55154-4513-390 in 1 CARTON
1NDC:55154-4513-61 in 1 POUCH
2NDC:55154-4513-010 in 1 BAG
21 in 1 POUCH
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021071 05/29/1999
AVANDIArosiglitazone maleate TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55154-4518(NDC:0029-3160)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ROSIGLITAZONE MALEATE(UNII: KX2339DP44)
(ROSIGLITAZONE - UNII:05V02F2KDG) 		ROSIGLITAZONE MALEATE8 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSE 2910 (3 MPA.S)(UNII: 0VUT3PMY82)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 3000(UNII: SA1B764746)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)
TALC(UNII: 7SEV7J4R1U)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
Color RED (red-brown) Score no score
Shape FREEFORM (pentagonal) Size 12 mm
Flavor Imprint Code SB;8
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55154-4518-430 in 1 CARTON
1NDC:55154-4518-61 in 1 POUCH
2NDC:55154-4518-010 in 1 BAG
21 in 1 POUCH
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021071 05/28/1999

PRINCIPAL DISPLAY PANEL

NDC 55154-4513-3

Avandia®

(rosiglitazone maleate) Tablets

4 mg

90 Tiltab® Tablets

Each Tiltab® tablet contains: rosiglitazone maleate equivalent to 4 mg rosiglitazone.

See product insert for dosage, prescribing information, precautions and warnings.

STORAGE: Store at 25°C (77°F); excursions 15°-30°C (59°-86°F).

Dispense in a tight, light-resistant container.

IMPORTANT: Use safety closures when dispensing this product unless otherwise directed by physician or requested by purchaser.

Federal Law requires dispensing of AVANDIA® with the Medication Guide provided with this package.

RX ONLY

WARNING: This package is intended for institutional use only. This package is not child resistant. Keep this and all drugs out of the reach of children.

See window for lot number and expiration date.

GlaxoSmithKline

RTP, NC 27709

Made in Ireland

Repackaged by: Cardinal Health

Zanesville, OH 43701

LUC39797130610

Avandia Carton

PRINCIPAL DISPLAY PANEL

Avandia®

(rosiglitazone maleate)

Tiltab® Tablet

4 mg

Avandia Pouch

PRINCIPAL DISPLAY PANEL

Avandia® 4 mg

Rosiglitazone MaleateTablets

10 Tiltab® Tablets

Bag label

PRINCIPAL DISPLAY PANEL

NDC 55154-4518-4

Avandia®

(rosiglitazone maleate) Tablets

8 mg

30 Tiltab® Tablets

Each Tiltab® tablet contains: rosiglitazone maleate equivalent to 8 mg rosiglitazone.

See product insert for dosage, prescribing information, precautions and warnings.

STORAGE: Store at 25°C (77°F); excursions 15°-30°C (59°-86°F).

RX ONLY

WARNING: This package is intended for institutional use only. This package is not child resistant. Keep this and all drugs out of the reach of children.

See window for lot number and expiration date.

GlaxoSmithKline

RTP, NC 27709

Made in Ireland

Repackaged by: Cardinal Health

Zanesville, OH 43701

LUC40835310610

Avandia Carton

PRINCIPAL DISPLAY PANEL

Avandia®

(rosiglitazone maleate)

Tiltab® Tablet

8 mg

Avandia Pouch

PRINCIPAL DISPLAY PANEL

Avandia® 8 mg

Rosiglitazone Maleate Tablets

10 Tiltab® Tablet

Bag Label