Azithromycin Monohydrate (Page 8 of 8)

‚ÄčPACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Azithromycin Tablets USP, 250 mg

Container Label-30 Tablets

NDC 68180-160-06

Bottle Label -- 30 Tablets -- 250 mg
(click image for full-size original)

Azithromycin Tablets USP, 250 mg

3 Card x 6 Tablets- Outer Carton Label

NDC 68180-160-13

Carton -- 250 mg
(click image for full-size original)

Azithromycin Tablets USP, 250 mg

6 Tablets- Blister Card

NDC 68180-160-11

Blister Card -- 250 mg
(click image for full-size original)

Azithromycin Tablets USP, 500 mg

Container Label-30 Tablets

NDC 68180-161-06

Bottle Label -- 30 tablets -- 500 mg
(click image for full-size original)

Azithromycin Tablets USP, 500 mg

3 Card x 3 Tablets- Outer Carton Label

NDC 68180-161-13

Carton -- 500 mg
(click image for full-size original)

Azithromycin Tablets USP, 500 mg

3 Tablets- Blister Card

NDC 68180-161-11

Blister card -- 500 mg
(click image for full-size original)
AZITHROMYCIN MONOHYDRATE azithromycin monohydrate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57297-160
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AZITHROMYCIN MONOHYDRATE (AZITHROMYCIN ANHYDROUS) AZITHROMYCIN ANHYDROUS 250 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
CROSCARMELLOSE SODIUM
D&C RED NO. 30
HYPROMELLOSE 2910 (15 MPA.S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color PINK Score no score
Shape OVAL Size 14mm
Flavor Imprint Code LU;L11
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57297-160-06 30 TABLET in 1 CONTAINER None
2 NDC:57297-160-13 3 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 6 TABLET in 1 BLISTER PACK This package is contained within the CARTON (57297-160-13)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065398 07/22/2015
AZITHROMYCIN MONOHYDRATE azithromycin monohydrate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57297-161
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AZITHROMYCIN MONOHYDRATE (AZITHROMYCIN ANHYDROUS) AZITHROMYCIN ANHYDROUS 500 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
CROSCARMELLOSE SODIUM
D&C RED NO. 30
HYPROMELLOSE 2910 (15 MPA.S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color PINK Score no score
Shape OVAL Size 17mm
Flavor Imprint Code LU;L12
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57297-161-06 30 TABLET in 1 CONTAINER None
2 NDC:57297-161-13 3 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 3 TABLET in 1 BLISTER PACK This package is contained within the CARTON (57297-161-13)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065399 07/22/2015
Labeler — LUPIN LIMITED (675923163)
Registrant — LUPIN LIMITED (675923163)
Establishment
Name Address ID/FEI Operations
LUPIN LIMITED 677600414 manufacture (57297-160), manufacture (57297-161), pack (57297-160), pack (57297-161)

Revised: 02/2016 LUPIN LIMITED

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