NDC Code(s) : 57297-201-01, 57297-201-08, 57297-201-10, 57297-201-25, 57297-208-08, 57297-208-11, 57297-208-02, 57297-203-10, 57297-203-08, 57297-203-11, 57297-203-02, 57297-205-10, 57297-205-08, 57297-205-11, 57297-205-02, 57297-206-01, 57297-206-02, 57297-206-03, 57297-206-06, 57297-206-05, 57297-206-04, 57297-207-02, 57297-207-03, 57297-207-04
Packager : LUPIN LIMITED

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

SUPRAXcefixime TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57297-201
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEFIXIME(UNII: 97I1C92E55)
(CEFIXIME ANHYDROUS - UNII:XZ7BG04GJX) 		CEFIXIME ANHYDROUS400 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE(UNII: O7TSZ97GEP)
HYPROMELLOSES(UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOLS(UNII: 3WJQ0SDW1A)
STARCH, PREGELATINIZED CORN(UNII: O8232NY3SJ)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)
Product Characteristics
Color WHITE (White to off white) Score 2 pieces
Shape CAPSULE (Capsule shaped tablets with beveled edges) Size 19 mm
Flavor Imprint Code SUPRAX;LUPIN
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:57297-201-01100 in 1 BOTTLE Type 0: Not a Combination Product
2NDC:57297-201-0850 in 1 BOTTLE Type 0: Not a Combination Product
3NDC:57297-201-1010 in 1 BOTTLE Type 0: Not a Combination Product
4NDC:57297-201-251 in 1 CARTON
42 in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065130 04/01/2008

INGREDIENTS AND APPEARANCE

SUPRAXcefixime CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57297-208
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEFIXIME(UNII: 97I1C92E55)
(CEFIXIME ANHYDROUS - UNII:XZ7BG04GJX) 		CEFIXIME ANHYDROUS400 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE(UNII: 68401960MK)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
GELATIN(UNII: 2G86QN327L)
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED(UNII: 2165RE0K14)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color PINK (Pink Opaque Cap), PINK (Pink Opaque Body) Score no score
Shape CAPSULE Size 26 mm
Flavor Imprint Code LU;U43
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:57297-208-0850 in 1 BOTTLE Type 0: Not a Combination Product
2NDC:57297-208-111 in 1 CARTON
210 in 1 BLISTER PACK Type 0: Not a Combination Product
3NDC:57297-208-021 in 1 CARTON
31 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA203195 03/15/2013

INGREDIENTS AND APPEARANCE

SUPRAXcefixime TABLET, CHEWABLE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57297-203
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEFIXIME(UNII: 97I1C92E55)
(CEFIXIME ANHYDROUS - UNII:XZ7BG04GJX) 		CEFIXIME ANHYDROUS100 mg
Inactive Ingredients
Ingredient Name Strength
ALUMINUM OXIDE(UNII: LMI26O6933)
ASPARTAME(UNII: Z0H242BBR1)
CROSPOVIDONE(UNII: 68401960MK)
FD&C RED NO. 40(UNII: WZB9127XOA)
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED(UNII: 2165RE0K14)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
Product Characteristics
Color PINK (Pink) Score no score
Shape ROUND (Round) Size 11 mm
Flavor TUTTI FRUTTI Imprint Code SUPRAX100;LUPIN
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:57297-203-1010 in 1 BOTTLE Type 0: Not a Combination Product
2NDC:57297-203-0850 in 1 BOTTLE Type 0: Not a Combination Product
3NDC:57297-203-111 in 1 CARTON
310 in 1 BLISTER PACK Type 0: Not a Combination Product
4NDC:57297-203-021 in 1 CARTON
41 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065380 12/05/2012

INGREDIENTS AND APPEARANCE

SUPRAXcefixime TABLET, CHEWABLE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57297-205
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEFIXIME(UNII: 97I1C92E55)
(CEFIXIME ANHYDROUS - UNII:XZ7BG04GJX) 		CEFIXIME ANHYDROUS200 mg
Inactive Ingredients
Ingredient Name Strength
ALUMINUM OXIDE(UNII: LMI26O6933)
ASPARTAME(UNII: Z0H242BBR1)
CROSPOVIDONE(UNII: 68401960MK)
FD&C RED NO. 40(UNII: WZB9127XOA)
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED(UNII: 2165RE0K14)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
Product Characteristics
Color PINK (Pink) Score no score
Shape ROUND (Round) Size 14 mm
Flavor Imprint Code SUPRAX200;LUPIN
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:57297-205-1010 in 1 BOTTLE Type 0: Not a Combination Product
2NDC:57297-205-0850 in 1 BOTTLE Type 0: Not a Combination Product
3NDC:57297-205-111 in 1 CARTON
310 in 1 BLISTER PACK Type 0: Not a Combination Product
4NDC:57297-205-021 in 1 CARTON
41 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065380 12/05/2012

INGREDIENTS AND APPEARANCE

SUPRAXcefixime POWDER, FOR SUSPENSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57297-206
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEFIXIME(UNII: 97I1C92E55)
(CEFIXIME ANHYDROUS - UNII:XZ7BG04GJX) 		CEFIXIME ANHYDROUS200 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM BENZOATE(UNII: OJ245FE5EU)
STRAWBERRY(UNII: 4J2TY8Y81V)
SUCROSE(UNII: C151H8M554)
XANTHAN GUM(UNII: TTV12P4NEE)
Product Characteristics
Color WHITE (Off White to Pale Yellow Powder) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:57297-206-01100 mL in 1 BOTTLE Type 0: Not a Combination Product
2NDC:57297-206-0275 mL in 1 BOTTLE Type 0: Not a Combination Product
3NDC:57297-206-0350 mL in 1 BOTTLE Type 0: Not a Combination Product
4NDC:57297-206-0637.5 mL in 1 BOTTLE Type 0: Not a Combination Product
5NDC:57297-206-0525 mL in 1 BOTTLE Type 0: Not a Combination Product
6NDC:57297-206-041 in 1 CARTON
610 mL in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065355 06/01/2007

INGREDIENTS AND APPEARANCE

SUPRAXcefixime POWDER, FOR SUSPENSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57297-207
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEFIXIME(UNII: 97I1C92E55)
(CEFIXIME ANHYDROUS - UNII:XZ7BG04GJX) 		CEFIXIME ANHYDROUS500 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM BENZOATE(UNII: OJ245FE5EU)
STRAWBERRY(UNII: 4J2TY8Y81V)
SUCRALOSE(UNII: 96K6UQ3ZD4)
SUCROSE(UNII: C151H8M554)
XANTHAN GUM(UNII: TTV12P4NEE)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:57297-207-0210 mL in 1 BOTTLE Type 0: Not a Combination Product
2NDC:57297-207-0320 mL in 1 BOTTLE Type 0: Not a Combination Product
3NDC:57297-207-041 in 1 CARTON
310 mL in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA202091 03/15/2013

PRINCIPAL DISPLAY PANEL

SUPRAX® CEFIXIME TABLETS USP

400 mg

Rx only

NDC 27437-201-10: Bottle of 10 Tablets

NDC 27437-201-25: Bottle of 2 Tablets [Physician Sample Pack]

NDC 27437-201-25: Carton for 2 Tablets [Physician Sample Pack]

SUPRAX CEFIXIME TABLETS USP 400 mg Rx only NDC 27437-201-10 - 10 Tablets Bottle PackSUPRAX CEFIXIME TABLETS USP 400 mg Rx only NDC 27437-201-10 - 10 Tablets Bottle PackSUPRAX CEFIXIME TABLETS USP 400 mg Rx only NDC 27437-201-10 - 10 Tablets Bottle Pack

SUPRAX® CEFIXIME CAPSULES

400 mg

Rx only

NDC 27437-208-08: Bottle of 50 Capsules

NDC 27437-208-11: Unit Dose Package of 10 (1 Blister of 10 Capsules)

NDC 27437-208-02: Single Dose Package of 1 (Blister of 1 Capsule)

SUPRAX CEFIXIME TABLETS USP 400 mg Rx only NDC 27437-201-10 - 10 Tablets Bottle PackSUPRAX CEFIXIME TABLETS USP 400 mg Rx only NDC 27437-201-10 - 10 Tablets Bottle PackSUPRAX CEFIXIME TABLETS USP 400 mg Rx only NDC 27437-201-10 - 10 Tablets Bottle PackSUPRAX CEFIXIME TABLETS USP 400 mg Rx only NDC 27437-201-10 - 10 Tablets Bottle PackSUPRAX CEFIXIME TABLETS USP 400 mg Rx only NDC 27437-201-10 - 10 Tablets Bottle Pack

SUPRAX® CEFIXIME CHEWABLE TABLETS

100 mg

Rx only

NDC 27437-203-10: Bottle of 10 Tablets

NDC 27437-203-11: Unit Dose Package of 10 (1 Blister of 10 Tablets)

NDC 27437-203-02: Unit Dose Package of 1 (1 Blister of 1 Tablet)

SUPRAX CEFIXIME TABLETS USP 400 mg Rx only NDC 27437-201-10 - 10 Tablets Bottle PackSUPRAX CEFIXIME TABLETS USP 400 mg Rx only NDC 27437-201-10 - 10 Tablets Bottle PackSUPRAX CEFIXIME TABLETS USP 400 mg Rx only NDC 27437-201-10 - 10 Tablets Bottle PackSUPRAX CEFIXIME TABLETS USP 400 mg Rx only NDC 27437-201-10 - 10 Tablets Bottle PackSUPRAX CEFIXIME TABLETS USP 400 mg Rx only NDC 27437-201-10 - 10 Tablets Bottle Pack

SUPRAX® CEFIXIME CHEWABLE TABLETS

150 mg

Rx only

NDC 27437-204-10: Bottle of 10 Tablets

NDC 27437-204-11: Unit Dose Package of 10 (1 Blister of 10 Tablets)

SUPRAX CEFIXIME TABLETS USP 400 mg Rx only NDC 27437-201-10 - 10 Tablets Bottle PackSUPRAX CEFIXIME TABLETS USP 400 mg Rx only NDC 27437-201-10 - 10 Tablets Bottle PackSUPRAX CEFIXIME TABLETS USP 400 mg Rx only NDC 27437-201-10 - 10 Tablets Bottle Pack

SUPRAX® CEFIXIME CHEWABLE TABLETS

200 mg

Rx only

NDC 27437-205-10: Bottle of 10 Tablets

NDC 27437-205-11: Unit Dose Package of 10 (1 Blister of 10 Tablets)

NDC 27437-205-02: Single Dose Package (Blister of 1 Tablet)

SUPRAX CEFIXIME TABLETS USP 400 mg Rx only NDC 27437-201-10 - 10 Tablets Bottle PackSUPRAX CEFIXIME TABLETS USP 400 mg Rx only NDC 27437-201-10 - 10 Tablets Bottle PackSUPRAX CEFIXIME TABLETS USP 400 mg Rx only NDC 27437-201-10 - 10 Tablets Bottle PackSUPRAX CEFIXIME TABLETS USP 400 mg Rx only NDC 27437-201-10 - 10 Tablets Bottle PackSUPRAX CEFIXIME TABLETS USP 400 mg Rx only NDC 27437-201-10 - 10 Tablets Bottle Pack

SUPRAX® CEFIXIME FOR ORAL SUSPENSION USP

200 mg/5 mL

Rx only

NDC 27437-206-05: Bottle of 25 mL

NDC 27437-206-04: Bottle of 10 mL [Physician Sample Pack]

NDC 27437-206-04: Carton for 10 mL [Physician Sample Pack]

SUPRAX CEFIXIME TABLETS USP 400 mg Rx only NDC 27437-201-10 - 10 Tablets Bottle PackSUPRAX CEFIXIME TABLETS USP 400 mg Rx only NDC 27437-201-10 - 10 Tablets Bottle PackSUPRAX CEFIXIME TABLETS USP 400 mg Rx only NDC 27437-201-10 - 10 Tablets Bottle Pack

SUPRAX® CEFIXIME FOR ORAL SUSPENSION USP

500 mg/5 mL

Rx only

NDC 27437-207-02: Bottle of 10 mL

NDC 27437-207-02: Carton for 10 mL

NDC 27437-207-04: Bottle of 10 mL [Physician Sample Pack]

NDC 27437-207-04: Carton for 10 mL [Physician Sample Pack]

SUPRAX CEFIXIME TABLETS USP 400 mg Rx only NDC 27437-201-10 - 10 Tablets Bottle PackSUPRAX CEFIXIME TABLETS USP 400 mg Rx only NDC 27437-201-10 - 10 Tablets Bottle PackSUPRAX CEFIXIME TABLETS USP 400 mg Rx only NDC 27437-201-10 - 10 Tablets Bottle PackSUPRAX CEFIXIME TABLETS USP 400 mg Rx only NDC 27437-201-10 - 10 Tablets Bottle Pack