Label: DOXYCYCLINE HYCLATE tablet
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NDC Code(s):
70771-1104-0,
70771-1104-1,
70771-1104-2,
70771-1104-4, view more70771-1104-5, 70771-1104-7
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated November 5, 2022
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- SPL UNCLASSIFIED SECTION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DOXYCYCLINE HYCLATE
doxycycline hyclate tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1104 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 ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, CORN (UNII: O8232NY3SJ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color YELLOW (BEIGE COLORED) Score no score Shape ROUND (BICONVEX) Size 9mm Flavor Imprint Code D77 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1104-7 50 in 1 BOTTLE; Type 0: Not a Combination Product 04/02/2018 2 NDC:70771-1104-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 04/02/2018 3 NDC:70771-1104-0 1000 in 1 BOTTLE; Type 0: Not a Combination Product 04/02/2018 4 NDC:70771-1104-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 04/02/2018 5 NDC:70771-1104-4 10 in 1 CARTON 04/02/2018 5 NDC:70771-1104-2 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 ANDA207773 04/02/2018 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (863362789) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 863362789 ANALYSIS(70771-1104) , MANUFACTURE(70771-1104)
