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| NDC | 70771-1422-1, 70771-1423-2, 70771-1424-2, 70771-1425-2 |
| Set ID | 0b63649d-558c-4250-90ee-af6e1e5c6d2c |
| Category | HUMAN PRESCRIPTION DRUG LABEL |
| Packager | Cadila Healthcare Limited |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | ANDA211147 |
- SPL UNCLASSIFIED SECTION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
AZITHROMYCIN
azithromycin powder, for suspensionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1422 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AZITHROMYCIN DIHYDRATE (UNII: 5FD1131I7S) (AZITHROMYCIN ANHYDROUS - UNII:J2KLZ20U1M) AZITHROMYCIN ANHYDROUS 100 mg in 5 mL Inactive Ingredients Ingredient Name Strength FD&C RED NO. 40 (UNII: WZB9127XOA) HYDROXYPROPYL CELLULOSE (90000 WAMW) (UNII: UKE75GEA7F) MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T) SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS (UNII: SX01TZO3QZ) SUCROSE (UNII: C151H8M554) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color WHITE (WHITE TO LIGHT PINK) Score Shape Size Flavor CHERRY (CHERRY) , BANANA (RIPE BANANA) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1422-1 1 in 1 CARTON 08/06/2018 1 15 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA211147 08/06/2018 AZITHROMYCIN
azithromycin powder, for suspensionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1423 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AZITHROMYCIN DIHYDRATE (UNII: 5FD1131I7S) (AZITHROMYCIN ANHYDROUS - UNII:J2KLZ20U1M) AZITHROMYCIN ANHYDROUS 200 mg in 5 mL Inactive Ingredients Ingredient Name Strength FD&C RED NO. 40 (UNII: WZB9127XOA) HYDROXYPROPYL CELLULOSE (90000 WAMW) (UNII: UKE75GEA7F) MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T) SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS (UNII: SX01TZO3QZ) SUCROSE (UNII: C151H8M554) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color WHITE (WHITE TO LIGHT PINK) Score Shape Size Flavor CHERRY (CHERRY) , BANANA (RIPE BANANA) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1423-2 1 in 1 CARTON 08/06/2018 1 15 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA211147 08/06/2018 AZITHROMYCIN
azithromycin powder, for suspensionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1424 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AZITHROMYCIN DIHYDRATE (UNII: 5FD1131I7S) (AZITHROMYCIN ANHYDROUS - UNII:J2KLZ20U1M) AZITHROMYCIN ANHYDROUS 200 mg in 5 mL Inactive Ingredients Ingredient Name Strength FD&C RED NO. 40 (UNII: WZB9127XOA) HYDROXYPROPYL CELLULOSE (90000 WAMW) (UNII: UKE75GEA7F) MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T) SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS (UNII: SX01TZO3QZ) SUCROSE (UNII: C151H8M554) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color WHITE (WHITE TO LIGHT PINK) Score Shape Size Flavor CHERRY (CHERRY) , BANANA (RIPE BANANA) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1424-2 1 in 1 CARTON 08/06/2018 1 22.5 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA211147 08/06/2018 AZITHROMYCIN
azithromycin powder, for suspensionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1425 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AZITHROMYCIN DIHYDRATE (UNII: 5FD1131I7S) (AZITHROMYCIN ANHYDROUS - UNII:J2KLZ20U1M) AZITHROMYCIN ANHYDROUS 200 mg in 5 mL Inactive Ingredients Ingredient Name Strength FD&C RED NO. 40 (UNII: WZB9127XOA) HYDROXYPROPYL CELLULOSE (90000 WAMW) (UNII: UKE75GEA7F) MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T) SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS (UNII: SX01TZO3QZ) SUCROSE (UNII: C151H8M554) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color WHITE (WHITE TO LIGHT PINK) Score Shape Size Flavor CHERRY (CHERRY) , BANANA (RIPE BANANA) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1425-2 1 in 1 CARTON 08/06/2018 1 30 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA211147 08/06/2018 Labeler - Cadila Healthcare Limited (918596198) Registrant - CADILA HEALTHCARE LIMITED (677605858) Establishment Name Address ID/FEI Business Operations CADILA HEALTHCARE LIMITED 677605858 ANALYSIS(70771-1422, 70771-1423, 70771-1424, 70771-1425) , MANUFACTURE(70771-1422, 70771-1423, 70771-1424, 70771-1425)
