DOXYCYCLINE HYCLATE- doxycycline hyclate capsule 
Zydus Lifesciences Limited

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Doxycycline hyclate capsules

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1358-7

Doxycycline hyclate capsules, 50 mg

Rx only

50 capsules

Doxycycline hyclate capsules

NDC 70771-1359-7

Doxycycline hyclate capsules, 100 mg

Rx only

50 capsules

Doxycycline hyclate capsules
DOXYCYCLINE HYCLATE 
doxycycline hyclate capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1358
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOXYCYCLINE HYCLATE (UNII: 19XTS3T51U) (DOXYCYCLINE ANHYDROUS - UNII:334895S862) DOXYCYCLINE ANHYDROUS50 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorBLUE (BLUE) , WHITE (WHITE) Scoreno score
ShapeCAPSULE (CAPSULE) Size16mm
FlavorImprint Code CHL;D75
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1358-750 in 1 BOTTLE; Type 0: Not a Combination Product09/12/2018
2NDC:70771-1358-1100 in 1 BOTTLE; Type 0: Not a Combination Product09/12/2018
3NDC:70771-1358-5500 in 1 BOTTLE; Type 0: Not a Combination Product09/12/2018
4NDC:70771-1358-01000 in 1 BOTTLE; Type 0: Not a Combination Product09/12/2018
5NDC:70771-1358-410 in 1 CARTON09/12/2018
5NDC:70771-1358-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20777409/12/2018
DOXYCYCLINE HYCLATE 
doxycycline hyclate capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1359
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
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
ColorBLUE (LIGHT BLUE) , BLUE (LIGHT BLUE) Scoreno score
ShapeCAPSULE (CAPSULE) Size20mm
FlavorImprint Code CHL;D76
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1359-750 in 1 BOTTLE; Type 0: Not a Combination Product09/12/2018
2NDC:70771-1359-1100 in 1 BOTTLE; Type 0: Not a Combination Product09/12/2018
3NDC:70771-1359-5500 in 1 BOTTLE; Type 0: Not a Combination Product09/12/2018
4NDC:70771-1359-01000 in 1 BOTTLE; Type 0: Not a Combination Product09/12/2018
5NDC:70771-1359-410 in 1 CARTON09/12/2018
5NDC:70771-1359-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20777409/12/2018
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (863362789)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited863362789ANALYSIS(70771-1358, 70771-1359) , MANUFACTURE(70771-1358, 70771-1359)

Revised: 8/2024
Document Id: cb5b26e1-ae6e-46a2-9edd-e3e98ced7a6d
Set id: fc8213e3-e546-495f-ac2c-3856db79c6e1
Version: 6
Effective Time: 20240816
 
Zydus Lifesciences Limited