DOXYCYCLINE HYCLATE - doxycycline hyclate tablet 
Zydus Lifesciences Limited

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Doxycycline hyclate Tablets

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1104-7

Doxycycline Hyclate Tablets, 100 mg

Rx only

50 tablets

Doxycycline hyclate tablets
DOXYCYCLINE HYCLATE 
doxycycline hyclate tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1104
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOXYCYCLINE HYCLATE (UNII: 19XTS3T51U) (DOXYCYCLINE ANHYDROUS - UNII:334895S862) DOXYCYCLINE ANHYDROUS100 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorYELLOW (BEIGE COLORED) Scoreno score
ShapeROUND (BICONVEX) Size9mm
FlavorImprint Code D77
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1104-750 in 1 BOTTLE; Type 0: Not a Combination Product04/02/2018
2NDC:70771-1104-1100 in 1 BOTTLE; Type 0: Not a Combination Product04/02/2018
3NDC:70771-1104-01000 in 1 BOTTLE; Type 0: Not a Combination Product04/02/2018
4NDC:70771-1104-5500 in 1 BOTTLE; Type 0: Not a Combination Product04/02/2018
5NDC:70771-1104-410 in 1 CARTON04/02/2018
5NDC:70771-1104-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20777304/02/2018
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (863362789)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited863362789ANALYSIS(70771-1104) , MANUFACTURE(70771-1104)

Revised: 11/2022
Document Id: 57e3e983-6e66-48a0-8710-b3dd4a57cb15
Set id: 68b3aba5-f1e4-4cdf-b244-0302aa8595fe
Version: 4
Effective Time: 20221105
 
Zydus Lifesciences Limited