Azithromycin (Page 8 of 8)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 250 mg (30 Tablets Bottle)

NDC 65862-641-30
Rx only
Azithromycin
Tablets, USP
250 mg
AUROBINDO 30 Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 250 mg (30 Tablets Bottle)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 250 mg (1 x 6) Unit-dose Tablets

NDC 65862-641-69 Rx only
Azithromycin Tablets, USP
250 mg
A full course of antibiotic therapy in 5 daily doses
AUROBINDO 6 Tablets (1 Blister x Six 250 mg Tablets )

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 250 mg (1 x 6) Unit-dose Tablets
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 250 mg (3 x 6) Unit-dose Tablets

NDC 65862-641-63
Rx only
Azithromycin Tablets, USP
250 mg
A full course of antibiotic therapy in 5 daily doses

AUROBINDO 18 Tablets (3 Cartons x Six 250 mg Tablets)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 250 mg (3 x 6) Unit-dose Tablets
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 250 mg (3 x 6) Unit-dose Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 500 mg (30 Tablets Bottle)

NDC 65862-642-30
Rx only
Azithromycin Tablets, USP
500 mg
AUROBINDO 30 Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 500 mg (30 Tablets Bottle)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 500 mg (30 Tablets Bottle)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 500 mg 3 Tablets (1 Blister x Three 500 mg Tablets)

NDC 65862-642-64
Rx only
Azithromycin Tablets, USP
500 mg
A full course of antibiotic therapy in 3 daily doses.
AUROBINDO 3 Tablets (1 Blister x Three 500 mg Tablets)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 500 mg 3 Tablets (1 Blister x Three 500 mg Tablets)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 500 mg 9 Tablets (3 Cartons x Three 500 mg Tablets)

NDC 65862-642-90 Rx only
Azithromycin Tablets, USP
500 mg
A full course of antibiotic therapy in 3 daily doses. AUROBINDO 9 Tablets (3 Cartons x Three 500 mg Tablets)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 500 mg 9 Tablets (3 Cartons x Three 500 mg Tablets)
(click image for full-size original)
AZITHROMYCIN azithromycin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65862-641
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AZITHROMYCIN DIHYDRATE (AZITHROMYCIN ANHYDROUS) AZITHROMYCIN ANHYDROUS 250 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
HYPROMELLOSE 2910 (15 MPA.S)
LACTOSE MONOHYDRATE
STARCH, CORN
MAGNESIUM STEARATE
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color WHITE (White to Off-white) Score no score
Shape CAPSULE (modified capsule shaped, biconvex) Size 14mm
Flavor Imprint Code 66;D
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65862-641-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:65862-641-50 50 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:65862-641-01 100 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:65862-641-05 500 TABLET, FILM COATED in 1 BOTTLE None
5 NDC:65862-641-69 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
5 6 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (65862-641-69)
6 NDC:65862-641-63 3 BLISTER PACK in 1 CARTON contains a BLISTER PACK
6 6 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (65862-641-63)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207370 07/05/2018
AZITHROMYCIN azithromycin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65862-642
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AZITHROMYCIN DIHYDRATE (AZITHROMYCIN ANHYDROUS) AZITHROMYCIN ANHYDROUS 500 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
HYPROMELLOSE 2910 (15 MPA.S)
LACTOSE MONOHYDRATE
STARCH, CORN
MAGNESIUM STEARATE
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color WHITE (White to Off-white) Score no score
Shape OVAL (Biconvex) Size 17mm
Flavor Imprint Code 67;D
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65862-642-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:65862-642-64 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 3 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (65862-642-64)
3 NDC:65862-642-90 3 BLISTER PACK in 1 CARTON contains a BLISTER PACK
3 3 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (65862-642-90)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207398 07/05/2018
Labeler — Aurobindo Pharma Limited (650082092)
Establishment
Name Address ID/FEI Operations
Aurobindo Pharma Limited 650381903 ANALYSIS (65862-641), ANALYSIS (65862-642), MANUFACTURE (65862-641), MANUFACTURE (65862-642)

Revised: 06/2021 Aurobindo Pharma Limited

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