AZITHROMYCIN (Page 8 of 8)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 600 mg – 200 mg/5 mL — Bottle

Azithromycin for Oral Suspension, USP

600 mg (15 mL when mixed)

200 mg/5 mL

Rx Only

600 mg container label
(click image for full-size original)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 600 mg – 200 mg/5 mL — Carton

Azithromycin for Oral Suspension, USP

600 mg (15 mL when mixed)

200 mg/5 mL

Rx Only

600 mg carton label
(click image for full-size original)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 600 mg – 200 mg/5 mL — Carton

Azithromycin for Oral Suspension, USP

1200 mg (30 mL when mixed)

200 mg/5 mL

Rx Only

1200 mg container label
(click image for full-size original)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 1200 mg – 200 mg/5 mL — Carton

Azithromycin for Oral Suspension, USP

1200 mg (30 mL when mixed)

200 mg/5 mL

Rx Only

1200 mg carton label
(click image for full-size original)
AZITHROMYCIN azithromycin powder, for suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24658-706
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AZITHROMYCIN MONOHYDRATE (AZITHROMYCIN ANHYDROUS) AZITHROMYCIN ANHYDROUS 200 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
SILICON DIOXIDE
FD&C RED NO. 40
SUCROSE
XANTHAN GUM
BANANA
CHERRY
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS
Product Characteristics
Color WHITE (Off-white) , PINK (pinkish) Score
Shape Size
Flavor BANANA (Banana-Cherry) , CHERRY (Banana-Cherry) Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:24658-706-32 15 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207531 04/30/2020
AZITHROMYCIN azithromycin powder, for suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24658-708
Route of Administration PARENTERAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AZITHROMYCIN MONOHYDRATE (AZITHROMYCIN ANHYDROUS) AZITHROMYCIN ANHYDROUS 200 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
SILICON DIOXIDE
FD&C RED NO. 40
SUCROSE
XANTHAN GUM
BANANA
CHERRY
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS
Product Characteristics
Color WHITE (Off-white) , PINK (pinkish) Score
Shape Size
Flavor BANANA (Banana-Cherry) , CHERRY (Banana-Cherry) Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:24658-708-34 30 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207531 04/30/2020
Labeler — PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS (080210964)
Registrant — Epic Pharma, LLC (827915443)
Establishment
Name Address ID/FEI Operations
Epic Pharma, LLC 827915443 MANUFACTURE (24658-706), MANUFACTURE (24658-708)

Revised: 04/2020 PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS

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