CIDOFOVIR DIHYDRATE (Page 6 of 6)

Package label principal display panel-Label

NDC 23155-216 -31

Cidofovir Injection, USP

375 mg/5 mL

(75 mg/mL)

Rx only

DILUTE BEFORE USE

FOR I.V. INFUSION ONLY.

Not for Intraocular Injection.

5 mL Single-Dose Vial

Label
(click image for full-size original)

Package label principal display panel-Carton

NDC 23155-216 -31

Cidofovir Injection, USP

375 mg/5 mL

(75 mg/mL)

Rx only

DILUTE BEFORE USE

FOR I.V. INFUSION ONLY.

Not for Intraocular Injection.

5 mL Single-Dose Vial

carton
(click image for full-size original)
CIDOFOVIR DIHYDRATE cidofovir dihydrate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:23155-216
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CIDOFOVIR (CIDOFOVIR ANHYDROUS) CIDOFOVIR ANHYDROUS 375 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM HYDROXIDE
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:23155-216-31 5 mL in 1 VIAL, GLASS None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202501 08/06/2012
Labeler — Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. (780779901)
Registrant — AVET LIFESCIENCES PRIVATE LIMITED (853181664)
Establishment
Name Address ID/FEI Operations
Maiva Pharma Private Limited 725656438 ANALYSIS (23155-216), LABEL (23155-216), MANUFACTURE (23155-216), PACK (23155-216)

Revised: 10/2023 Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

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