Label: DOXYCYCLINE tablet, film coated
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NDC Code(s):
70771-1006-1,
70771-1007-1,
70771-1008-7,
70771-1008-8, view more70771-1009-1, 70771-1009-3
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated October 13, 2022
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DOXYCYCLINE
doxycycline tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1006 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 CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) CROSPOVIDONE (UNII: 2S7830E561) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYSORBATE 80 (UNII: 6OZP39ZG8H) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color YELLOW (PALE YELLOW) Score no score Shape ROUND (biconvex, beveled edged) Size 7mm Flavor Imprint Code 1121 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1006-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 01/11/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA209582 01/11/2018 DOXYCYCLINE
doxycycline tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1007 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 CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) CROSPOVIDONE (UNII: 2S7830E561) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) Product Characteristics Color ORANGE (CREAMISH ORANGE) Score no score Shape ROUND (biconvex, beveled edged) Size 8mm Flavor Imprint Code 1122 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1007-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 01/11/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA209582 01/11/2018 DOXYCYCLINE
doxycycline tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1008 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 CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) CROSPOVIDONE (UNII: 2S7830E561) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C RED NO. 40 (UNII: WZB9127XOA) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYSORBATE 80 (UNII: 6OZP39ZG8H) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color YELLOW (LEMON YELLOW TO BUFF COLORED) Score no score Shape ROUND (biconvex, beveled edged) Size 9mm Flavor Imprint Code 1123 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1008-7 50 in 1 BOTTLE; Type 0: Not a Combination Product 01/11/2018 2 NDC:70771-1008-8 250 in 1 BOTTLE; Type 0: Not a Combination Product 01/11/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA209582 01/11/2018 DOXYCYCLINE
doxycycline tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1009 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DOXYCYCLINE (UNII: N12000U13O) (DOXYCYCLINE ANHYDROUS - UNII:334895S862) DOXYCYCLINE ANHYDROUS 150 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) CROSPOVIDONE (UNII: 2S7830E561) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) Product Characteristics Color ORANGE (DARK ORANGE TO CREAMISH ORANGE) Score 2 pieces Shape ROUND (biconvex, beveled edged) Size 11mm Flavor Imprint Code 1124 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1009-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 01/11/2018 2 NDC:70771-1009-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 01/11/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA209582 01/11/2018 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 863362789 ANALYSIS(70771-1006, 70771-1007, 70771-1008, 70771-1009) , MANUFACTURE(70771-1006, 70771-1007, 70771-1008, 70771-1009)
