DOXYCYCLINE HYCLATE capsule
Doxycycline hyclate by
Drug Labeling and Warnings
Doxycycline hyclate by is a Prescription medication manufactured, distributed, or labeled by Zydus Lifesciences Limited. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
- SPL UNCLASSIFIED SECTION
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC: 70771-1358-7
Doxycycline hyclate capsules, 50 mg
Rx only
50 capsules
NDC: 70771-1359-7
Doxycycline hyclate capsules, 100 mg
Rx only
50 capsules
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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 - Cadila Healthcare Limited (918596198) Registrant - Cadila Healthcare Limited (863362789) Establishment Name Address ID/FEI Business Operations Cadila Healthcare Limited 863362789 ANALYSIS(70771-1358, 70771-1359) , MANUFACTURE(70771-1358, 70771-1359)
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