DOXYCYCLINE - doxycycline injection, powder, lyophilized, for solution 
Zydus Lifesciences Limited

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Doxycycline For Injection USP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL – DOXYCYCLINE 100 MG CONTAINER LABEL

NDC 70771-1121-1

Doxycycline for Injection, USP

100 mg per vial

For Intravenous Infusion

MUST DILUTE RECONSTITUTED SOLUTION

Single-dose vial

Rx only

Zydus Pharmaceuticals

100 mg per vial Container Label

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - DOXYCYCLINE 100 MG CARTON LABEL

NDC 70771-1121-6

Doxycycline for Injection, USP

100 mg per vial

For Intravenous Infusion

MUST DILUTE RECONSTITUTED SOLUTION

10 x Single-dose vials

Rx only

Zydus Pharmaceuticals

100 mg per vial Carton Label

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL – DOXYCYCLINE 200 MG CONTAINER LABEL

NDC 70771-1122-1

Doxycycline for Injection, USP

200 mg per vial

For Intravenous Infusion

MUST DILUTE RECONSTITUTED SOLUTION

Single-dose vial

Rx only

Zydus Pharmaceuticals

200 mg per vial Container Label

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - DOXYCYCLINE 200 MG CARTON LABEL

NDC 70771-1122-1

Doxycycline for Injection, USP

200 mg per vial

For Intravenous Infusion

MUST DILUTE RECONSTITUTED SOLUTION

Single-dose vial

Rx only

Zydus Pharmaceuticals

200 mg per vial Carton Label
DOXYCYCLINE 
doxycycline injection, powder, lyophilized, for solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1121
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOXYCYCLINE HYCLATE (UNII: 19XTS3T51U) (DOXYCYCLINE ANHYDROUS - UNII:334895S862) DOXYCYCLINE ANHYDROUS100 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
ASCORBIC ACID (UNII: PQ6CK8PD0R) 480 mg  in 10 mL
MANNITOL (UNII: 3OWL53L36A) 300 mg  in 10 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1121-610 in 1 CARTON02/01/2018
1NDC:70771-1121-110 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20775702/01/2018
DOXYCYCLINE 
doxycycline injection, powder, lyophilized, for solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1122
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOXYCYCLINE HYCLATE (UNII: 19XTS3T51U) (DOXYCYCLINE ANHYDROUS - UNII:334895S862) DOXYCYCLINE ANHYDROUS200 mg  in 20 mL
Inactive Ingredients
Ingredient NameStrength
ASCORBIC ACID (UNII: PQ6CK8PD0R) 960 mg  in 20 mL
MANNITOL (UNII: 3OWL53L36A) 600 mg  in 20 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1122-11 in 1 CARTON02/01/2018
120 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20775702/01/2018
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited918596198ANALYSIS(70771-1121, 70771-1122) , MANUFACTURE(70771-1121, 70771-1122)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited873671928MANUFACTURE(70771-1121, 70771-1122) , ANALYSIS(70771-1121, 70771-1122)

Revised: 11/2022
Document Id: 6782ec89-eb1e-4283-9b02-b9fda4793cd3
Set id: 6ae11b4e-1c13-440b-a050-d76e062b0f92
Version: 6
Effective Time: 20221105
 
Zydus Lifesciences Limited