Cefadroxil (Page 3 of 3)

HOW SUPPLIED

Cefadroxil for Oral Suspension, USP is an off white to light orange colored granular powder which after reconstitution is orange colored and is orange-pineapple flavored, and is supplied as follows:

250 mg/5 mL

50 mL Bottle NDC 57237-097-50
100 mL Bottle NDC 57237-097-01

500 mg/5 mL

75 mL Bottle NDC 57237-098-75
100 mL Bottle NDC 57237-098-01

Prior to reconstitution: Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Distributed by:
Rising Health, LLC
Saddle Brook, NJ 07663

Made in India

Code: TS/DRUGS/78/1996
Revised: 10/2018

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 250 mg/5 mL (100 mL WHEN MIXED)

Rising® NDC 57237-097-01
Cefadroxil for Oral
Suspension, USP
250 mg/5 mL
100 mL Rx only
(WHEN MIXED)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 250 mg/5 mL (100 mL WHEN MIXED)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 500 mg/5 mL (100 mL WHEN MIXED)

Rising® NDC 57237-098-01
Cefadroxil for Oral
Suspension, USP
500 mg/5 mL
100 mL Rx only
(WHEN MIXED)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 500 mg/5 mL (100 mL WHEN MIXED)
(click image for full-size original)

CEFADROXIL cefadroxil powder, for suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57237-097
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEFADROXIL (CEFADROXIL ANHYDROUS) CEFADROXIL ANHYDROUS 250 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
FD&C YELLOW NO. 6
POLYSORBATE 80
SODIUM BENZOATE
SUCROSE
XANTHAN GUM
SULFUR DIOXIDE
Product Characteristics
Color ORANGE (off white to light orange) Score
Shape Size
Flavor ORANGE, PINEAPPLE Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57237-097-50 50 mL in 1 BOTTLE None
2 NDC:57237-097-01 100 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065349 04/25/2013
CEFADROXIL cefadroxil powder, for suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57237-098
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEFADROXIL (CEFADROXIL ANHYDROUS) CEFADROXIL ANHYDROUS 500 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
FD&C YELLOW NO. 6
POLYSORBATE 80
SODIUM BENZOATE
SUCROSE
XANTHAN GUM
SULFUR DIOXIDE
Product Characteristics
Color ORANGE (off white to light orange) Score
Shape Size
Flavor ORANGE, PINEAPPLE Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57237-098-75 75 mL in 1 BOTTLE None
2 NDC:57237-098-01 100 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065349 04/25/2013
Labeler — Rising Pharma Holdings, Inc. (116880195)
Registrant — Aurobindo Pharma Limited (650082092)
Establishment
Name Address ID/FEI Operations
Aurobindo Pharma Limited 918917639 ANALYSIS (57237-097), ANALYSIS (57237-098), MANUFACTURE (57237-097), MANUFACTURE (57237-098)

Revised: 02/2024 Rising Pharma Holdings, Inc.

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