Label: DOXYCYCLINE capsule
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NDC Code(s):
65841-821-01,
65841-821-05,
65841-821-06,
65841-821-10, view more65841-821-16, 65841-821-18, 65841-821-30, 65841-821-77, 65841-822-01, 65841-822-05, 65841-822-06, 65841-822-10, 65841-822-16, 65841-822-18, 65841-822-30, 65841-822-77, 65841-823-01, 65841-823-05, 65841-823-06, 65841-823-10, 65841-823-16, 65841-823-18, 65841-823-21, 65841-823-30, 65841-823-77
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
Drug Label Information
Updated August 25, 2022
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- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DOXYCYCLINE
doxycycline capsuleProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-821 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DOXYCYCLINE (UNII: N12000U13O) (DOXYCYCLINE ANHYDROUS - UNII:334895S862) DOXYCYCLINE ANHYDROUS 50 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) GELATIN (UNII: 2G86QN327L) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) AMMONIA (UNII: 5138Q19F1X) Product Characteristics Color YELLOW (OPAQUE YELLOW) , WHITE (OPAQUE WHITE) Score no score Shape CAPSULE (CAPSULE) Size 16mm Flavor Imprint Code 782 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-821-06 30 in 1 BOTTLE; Type 0: Not a Combination Product 03/14/2016 2 NDC:65841-821-18 50 in 1 BOTTLE; Type 0: Not a Combination Product 03/14/2016 3 NDC:65841-821-16 90 in 1 BOTTLE; Type 0: Not a Combination Product 03/14/2016 4 NDC:65841-821-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 03/14/2016 5 NDC:65841-821-05 500 in 1 BOTTLE; Type 0: Not a Combination Product 03/14/2016 6 NDC:65841-821-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 03/14/2016 7 NDC:65841-821-77 10 in 1 CARTON 03/14/2016 7 NDC:65841-821-30 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 ANDA205115 03/14/2016 DOXYCYCLINE
doxycycline capsuleProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-822 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DOXYCYCLINE (UNII: N12000U13O) (DOXYCYCLINE ANHYDROUS - UNII:334895S862) DOXYCYCLINE ANHYDROUS 75 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) GELATIN (UNII: 2G86QN327L) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 3 (UNII: PN2ZH5LOQY) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) FERROSOFERRIC OXIDE (UNII: XM0M87F357) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) AMMONIA (UNII: 5138Q19F1X) Product Characteristics Color ORANGE (OPAQUE ORANGE) , WHITE (OPAQUE WHITE) Score no score Shape CAPSULE (CAPSULE) Size 18mm Flavor Imprint Code 706 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-822-06 30 in 1 BOTTLE; Type 0: Not a Combination Product 03/14/2016 2 NDC:65841-822-18 50 in 1 BOTTLE; Type 0: Not a Combination Product 03/14/2016 3 NDC:65841-822-16 90 in 1 BOTTLE; Type 0: Not a Combination Product 03/14/2016 4 NDC:65841-822-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 03/14/2016 5 NDC:65841-822-05 500 in 1 BOTTLE; Type 0: Not a Combination Product 03/14/2016 6 NDC:65841-822-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 03/14/2016 7 NDC:65841-822-77 10 in 1 CARTON 03/14/2016 7 NDC:65841-822-30 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 ANDA205115 03/14/2016 DOXYCYCLINE
doxycycline capsuleProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-823 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DOXYCYCLINE (UNII: N12000U13O) (DOXYCYCLINE ANHYDROUS - UNII:334895S862) DOXYCYCLINE ANHYDROUS 100 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) GELATIN (UNII: 2G86QN327L) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 3 (UNII: PN2ZH5LOQY) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) FERRIC OXIDE RED (UNII: 1K09F3G675) FERROSOFERRIC OXIDE (UNII: XM0M87F357) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) AMMONIA (UNII: 5138Q19F1X) Product Characteristics Color YELLOW (OPAQUE YELLOW) , ORANGE (OPAQUE ORANGE) Score no score Shape CAPSULE (CAPSULE) Size 19mm Flavor Imprint Code 707 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-823-06 30 in 1 BOTTLE; Type 0: Not a Combination Product 03/14/2016 2 NDC:65841-823-18 50 in 1 BOTTLE; Type 0: Not a Combination Product 03/14/2016 3 NDC:65841-823-16 90 in 1 BOTTLE; Type 0: Not a Combination Product 03/14/2016 4 NDC:65841-823-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 03/14/2016 5 NDC:65841-823-21 250 in 1 BOTTLE; Type 0: Not a Combination Product 03/14/2016 6 NDC:65841-823-05 500 in 1 BOTTLE; Type 0: Not a Combination Product 03/14/2016 7 NDC:65841-823-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 03/14/2016 8 NDC:65841-823-77 10 in 1 CARTON 03/14/2016 8 NDC:65841-823-30 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 ANDA205115 03/14/2016 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (863362789) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 863362789 ANALYSIS(65841-821, 65841-822, 65841-823) , MANUFACTURE(65841-821, 65841-822, 65841-823)