facebook
Subscribe50$/product give away!


Submit an Article to Pharmacy HQ     
Please include the author's name, title, and citations.     

AZACITIDINE injection, powder, lyophilized, for solution


  1. Patient Information
  2. Manufactured By:
  3. Manufactured For:
  4. Manufactured By:
  5. Manufactured For:
  6. Revised: 9/2018document Id:

Patient Information 

Hepatic Toxicity in Patients with Severe Pre-Existing Hepatic Impairment

Instruct patients to inform their physician about any underlying liver disease.

Renal Toxicity

Instruct patients to inform their physician about any underlying renal disease[see Warnings and Precautions (5.3) and Use in Specific Populations (8.6)].

Embryo-Fetal Toxicity

Advise pregnant women and females of reproductive potential of the potential risk to a fetus[seeWarnings and Precautions (5.5)andUse in Specific Populations (8.1)].

Advise females of reproductive potential to avoid pregnancy during treatment with Azacitidine for Injection. Advise females of reproductive potential to use effective contraception during treatment with Azacitidine for Injection and for 6 months after the final dose[seeUse in Specific Populations (8.3)].

Advise male patients with female partners of reproductive potential to use effective contraception during treatment with Azacitidine for Injection and for 3 months after the final dose[seeUse in Specific Populations (8.3)].

Lactation

Advise women not to breastfeed during treatment with Azacitidine for Injection and for 1 week after the final dose[seeUse in Specific Populations (8.2)].

Infertility

Advise males and females of the potential for reduced fertility from Azacitidine for Injection[seeUse in Specific Populations (8.3)andNonclinical Toxicology (13.1)].

Manufactured by:
Sindan Pharma SRL
11 Ion Mihalache Blvd.
Bucharest 1, Romania 011171

For BluePoint Laboratories

Rev. A 9/2018

Manufactured By: 

Dr. Reddy s Laboratories Limited

Visakhapatnam - 530 046 INDIA

Revised: 1218

Manufactured For: 

Accord Healthcare, Inc.,

1009, Slater Road,

Suite 210-B

Durham, NC 27703,

USA.

Manufactured By: 

Intas Pharmaceuticals Limited,

Plot No. 5 to 14 Pharmez,

Nr. Village Matoda, Bavla Road,

Ta.-Sanand, Dist.

Ahmedabad-382 213,

India.

51 3597 0 720287

Issued: April 2019

Manufactured For: 

Logo

Lake Zurich, IL 60047
Made in India
www.fresenius-kabi.us 451537A

Revised: 09/2018
4500272

Principal Display Panel 100 mg Vial Label

NDC 63323-771-39
Azacitidine
for Injection
100 mg/vial

FOR SUBCUTANEOUS AND
INTRAVENOUS USE ONLY
Rx only

Single-Dose Vial

Principal Display Panel     100 mg Vial Label

Principal Display Panel 100 mg Carton

NDC 63323-771-39

Azacitidine

for Injection
100 mg/vial

FOR SUBCUTANEOUS
AND INTRAVENOUS USE ONLY

Rx only

One Single-Dose Vial

FRESENIUS
KABI

Principal Display Panel     100 mg Carton
AZACITIDINE
azacitidine injection, powder, lyophilized, for solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63323-771
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AZACITIDINE(UNII: M801H13NRU) (AZACITIDINE - UNII:M801H13NRU)AZACITIDINE100 mg in 30 mL
Inactive Ingredients
Ingredient NameStrength
MANNITOL(UNII: 3OWL53L36A)100 mg in 30 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63323-771-391 in 1 CARTON03/16/2017
130 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20751803/16/2017
Labeler -Fresenius Kabi USA, LLC (608775388)
Establishment
NameAddressID/FEIBusiness Operations
Shilpa Medicare Limited650644136MANUFACTURE(63323-771)

Revised: 9/2018document Id: 

cbae035f-274a-48b2-9a1b-cfe58aa7a8daSet id: 3b594aba-e798-4105-b801-0b0d970747c1Version: 3Effective Time: 20180930Fresenius Kabi USA, LLC



Your use of this website constitutes your agreement to the terms and conditions linked below:
Terms and Conditions | Resources
2017 © Copyright PharmacyHQ.com. Questions?
Please contact: pharmacyhq.mail@gmail.com