Label: DOXYCYCLINE HYCLATE capsule
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NDC Code(s):
70771-1358-0,
70771-1358-1,
70771-1358-2,
70771-1358-4, view more70771-1358-5, 70771-1358-7, 70771-1359-0, 70771-1359-1, 70771-1359-2, 70771-1359-4, 70771-1359-5, 70771-1359-7
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
Drug Label Information
Updated November 5, 2022
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INGREDIENTS AND APPEARANCE
DOXYCYCLINE HYCLATE
doxycycline hyclate capsuleProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1358 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DOXYCYCLINE HYCLATE (UNII: 19XTS3T51U) (DOXYCYCLINE ANHYDROUS - UNII:334895S862) DOXYCYCLINE ANHYDROUS 50 mg Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) AMMONIA (UNII: 5138Q19F1X) ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) BUTYL ALCOHOL (UNII: 8PJ61P6TS3) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) D&C RED NO. 28 (UNII: 767IP0Y5NH) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FERROSOFERRIC OXIDE (UNII: XM0M87F357) GELATIN (UNII: 2G86QN327L) ISOPROPYL ALCOHOL (UNII: ND2M416302) MAGNESIUM STEARATE (UNII: 70097M6I30) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color BLUE (BLUE) , WHITE (WHITE) Score no score Shape CAPSULE (CAPSULE) Size 16mm Flavor Imprint Code CHL;D75 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1358-7 50 in 1 BOTTLE; Type 0: Not a Combination Product 09/12/2018 2 NDC:70771-1358-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 09/12/2018 3 NDC:70771-1358-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 09/12/2018 4 NDC:70771-1358-0 1000 in 1 BOTTLE; Type 0: Not a Combination Product 09/12/2018 5 NDC:70771-1358-4 10 in 1 CARTON 09/12/2018 5 NDC:70771-1358-2 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA207774 09/12/2018 DOXYCYCLINE HYCLATE
doxycycline hyclate capsuleProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1359 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DOXYCYCLINE HYCLATE (UNII: 19XTS3T51U) (DOXYCYCLINE ANHYDROUS - UNII:334895S862) DOXYCYCLINE ANHYDROUS 100 mg Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) AMMONIA (UNII: 5138Q19F1X) ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) BUTYL ALCOHOL (UNII: 8PJ61P6TS3) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) D&C RED NO. 28 (UNII: 767IP0Y5NH) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FERROSOFERRIC OXIDE (UNII: XM0M87F357) GELATIN (UNII: 2G86QN327L) ISOPROPYL ALCOHOL (UNII: ND2M416302) MAGNESIUM STEARATE (UNII: 70097M6I30) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color BLUE (LIGHT BLUE) , BLUE (LIGHT BLUE) Score no score Shape CAPSULE (CAPSULE) Size 20mm Flavor Imprint Code CHL;D76 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1359-7 50 in 1 BOTTLE; Type 0: Not a Combination Product 09/12/2018 2 NDC:70771-1359-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 09/12/2018 3 NDC:70771-1359-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 09/12/2018 4 NDC:70771-1359-0 1000 in 1 BOTTLE; Type 0: Not a Combination Product 09/12/2018 5 NDC:70771-1359-4 10 in 1 CARTON 09/12/2018 5 NDC:70771-1359-2 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA207774 09/12/2018 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (863362789) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 863362789 ANALYSIS(70771-1358, 70771-1359) , MANUFACTURE(70771-1358, 70771-1359)
