DOXYCYCLINE- doxycycline capsule 
Zydus Lifesciences Limited

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Doxycycline Capsules, USP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-821-01 in bottle of 100 Capsules

Doxycycline Capsules USP, 50 mg

Rx Only

100 Capsules

Doxycycline Capsules 50 mg

NDC 65841-822-01 in bottle of 100 Capsules

Doxycycline Capsules USP, 75 mg

Rx Only

100 Capsules

Doxycycline Capsules 75 mg

NDC 65841-823-01 in bottle of 100 Capsules

Doxycycline Capsules USP, 100 mg

Rx Only

100 Capsules

Doxycycline Capsules 100 mg
DOXYCYCLINE 
doxycycline capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-821
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOXYCYCLINE (UNII: N12000U13O) (DOXYCYCLINE ANHYDROUS - UNII:334895S862) DOXYCYCLINE ANHYDROUS50 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorYELLOW (OPAQUE YELLOW) , WHITE (OPAQUE WHITE) Scoreno score
ShapeCAPSULE (CAPSULE) Size16mm
FlavorImprint Code 782
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-821-0630 in 1 BOTTLE; Type 0: Not a Combination Product03/14/2016
2NDC:65841-821-1850 in 1 BOTTLE; Type 0: Not a Combination Product03/14/2016
3NDC:65841-821-1690 in 1 BOTTLE; Type 0: Not a Combination Product03/14/2016
4NDC:65841-821-01100 in 1 BOTTLE; Type 0: Not a Combination Product03/14/2016
5NDC:65841-821-05500 in 1 BOTTLE; Type 0: Not a Combination Product03/14/2016
6NDC:65841-821-101000 in 1 BOTTLE; Type 0: Not a Combination Product03/14/2016
7NDC:65841-821-7710 in 1 CARTON03/14/2016
7NDC:65841-821-3010 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20511503/14/2016
DOXYCYCLINE 
doxycycline capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-822
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOXYCYCLINE (UNII: N12000U13O) (DOXYCYCLINE ANHYDROUS - UNII:334895S862) DOXYCYCLINE ANHYDROUS75 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorORANGE (OPAQUE ORANGE) , WHITE (OPAQUE WHITE) Scoreno score
ShapeCAPSULE (CAPSULE) Size18mm
FlavorImprint Code 706
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-822-0630 in 1 BOTTLE; Type 0: Not a Combination Product03/14/2016
2NDC:65841-822-1850 in 1 BOTTLE; Type 0: Not a Combination Product03/14/2016
3NDC:65841-822-1690 in 1 BOTTLE; Type 0: Not a Combination Product03/14/2016
4NDC:65841-822-01100 in 1 BOTTLE; Type 0: Not a Combination Product03/14/2016
5NDC:65841-822-05500 in 1 BOTTLE; Type 0: Not a Combination Product03/14/2016
6NDC:65841-822-101000 in 1 BOTTLE; Type 0: Not a Combination Product03/14/2016
7NDC:65841-822-7710 in 1 CARTON03/14/2016
7NDC:65841-822-3010 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20511503/14/2016
DOXYCYCLINE 
doxycycline capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-823
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOXYCYCLINE (UNII: N12000U13O) (DOXYCYCLINE ANHYDROUS - UNII:334895S862) DOXYCYCLINE ANHYDROUS100 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorYELLOW (OPAQUE YELLOW) , ORANGE (OPAQUE ORANGE) Scoreno score
ShapeCAPSULE (CAPSULE) Size19mm
FlavorImprint Code 707
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-823-0630 in 1 BOTTLE; Type 0: Not a Combination Product03/14/2016
2NDC:65841-823-1850 in 1 BOTTLE; Type 0: Not a Combination Product03/14/2016
3NDC:65841-823-1690 in 1 BOTTLE; Type 0: Not a Combination Product03/14/2016
4NDC:65841-823-01100 in 1 BOTTLE; Type 0: Not a Combination Product03/14/2016
5NDC:65841-823-21250 in 1 BOTTLE; Type 0: Not a Combination Product03/14/2016
6NDC:65841-823-05500 in 1 BOTTLE; Type 0: Not a Combination Product03/14/2016
7NDC:65841-823-101000 in 1 BOTTLE; Type 0: Not a Combination Product03/14/2016
8NDC:65841-823-7710 in 1 CARTON03/14/2016
8NDC:65841-823-3010 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20511503/14/2016
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (863362789)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited863362789ANALYSIS(65841-821, 65841-822, 65841-823) , MANUFACTURE(65841-821, 65841-822, 65841-823)

Revised: 11/2024
Document Id: d9de3252-a876-482e-be60-0a47eb985aa8
Set id: aa01035d-8b4a-4fdc-bfdf-2b39df0d8fc9
Version: 7
Effective Time: 20241128
 
Zydus Lifesciences Limited