Abacavir (Page 8 of 8)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 20 mg/mL (240 mL Bottle Label)

Rising® NDC 64980-405-24
Abacavir
Oral Solution USP
20 mg/mL
Notice to Authorized Dispenser:
Each time ABACAVIR ORAL SOLUTION
USP is dispensed, give the patient an
attached Medication Guide and Warning
Card from the carton.
240 mL Rx only

Figure 1
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 20 mg/mL (240 mL Carton Label)

Rising® NDC 64980-405-24
Abacavir
Oral Solution USP
20 mg/mL
Notice to Authorized Dispenser:
Each time ABACAVIR ORAL SOLUTION
USP is dispensed, give the patient an
attached Medication Guide and Warning
Card from the carton.
240 mL Rx only

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 20 mg/mL (240 mL Carton Label)
(click image for full-size original)

ABACAVIR abacavir sulfate solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64980-405
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ABACAVIR SULFATE (ABACAVIR) ABACAVIR 20 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
STRAWBERRY
BANANA
ANHYDROUS CITRIC ACID
METHYLPARABEN
PROPYLPARABEN
PROPYLENE GLYCOL
SACCHARIN SODIUM
TRISODIUM CITRATE DIHYDRATE
SORBITOL
WATER
Product Characteristics
Color YELLOW Score
Shape Size
Flavor BANANA, STRAWBERRY Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64980-405-24 1 BOTTLE in 1 CARTON contains a BOTTLE
1 240 mL in 1 BOTTLE This package is contained within the CARTON (64980-405-24)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077950 03/14/2018
Labeler — Rising Pharmaceuticals, Inc. (041241766)
Registrant — Aurobindo Pharma Limited (650082092)
Establishment
Name Address ID/FEI Operations
Aurobindo Pharma Limited 918917642 ANALYSIS (64980-405), MANUFACTURE (64980-405)

Revised: 09/2019 Rising Pharmaceuticals, Inc.

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