Doxycycline

DOXYCYCLINE — doxycycline hyclate injection, powder, lyophilized, for solution
Zydus Lifesciences Limited

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
(click image for full-size original)

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
(click image for full-size original)

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
(click image for full-size original)

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
(click image for full-size original)
DOXYCYCLINE
doxycycline injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1121
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOXYCYCLINE HYCLATE (DOXYCYCLINE ANHYDROUS) DOXYCYCLINE ANHYDROUS 100 mg in 10 mL
Inactive Ingredients
Ingredient Name Strength
ASCORBIC ACID 480 mg in 10 mL
MANNITOL 300 mg in 10 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1121-6 10 VIAL in 1 CARTON contains a VIAL (70771-1121-1)
1 NDC:70771-1121-1 10 mL in 1 VIAL This package is contained within the CARTON (70771-1121-6)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207757 02/01/2018
DOXYCYCLINE
doxycycline injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1122
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOXYCYCLINE HYCLATE (DOXYCYCLINE ANHYDROUS) DOXYCYCLINE ANHYDROUS 200 mg in 20 mL
Inactive Ingredients
Ingredient Name Strength
ASCORBIC ACID 960 mg in 20 mL
MANNITOL 600 mg in 20 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1122-1 1 VIAL in 1 CARTON contains a VIAL
1 20 mL in 1 VIAL This package is contained within the CARTON (70771-1122-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207757 02/01/2018
Labeler — Zydus Lifesciences Limited (918596198)
Registrant — Zydus Lifesciences Limited (918596198)
Establishment
Name Address ID/FEI Operations
Zydus Lifesciences Limited 918596198 ANALYSIS (70771-1121), ANALYSIS (70771-1122), MANUFACTURE (70771-1121), MANUFACTURE (70771-1122)
Establishment
Name Address ID/FEI Operations
Zydus Lifesciences Limited 873671928 MANUFACTURE (70771-1121), MANUFACTURE (70771-1122), ANALYSIS (70771-1121), ANALYSIS (70771-1122)

Revised: 11/2022 Zydus Lifesciences Limited

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