NDC 0006-4047

RotaTeq

Rotavirus Vaccine, Live, Oral, Pentavalent

RotaTeq is a Oral Solution in the Vaccine category. It is labeled and distributed by Merck Sharp & Dohme Corp.. The primary component is Human Rotavirus A Type G1p7(5) Strain Wi79 Live Antigen; Human Rotavirus A Type G2p7(5) Strain Sc2 Live Antigen; Human Rotavirus A Type G3p7(5) Strain Wi78 Live Antigen; Human Rotavirus A Type G4p7(5) Strain Brb Live Antigen; Human Rotavirus A Type G6p1a(8) Strain Wi79 Live Antigen.

Product ID0006-4047_05a6cc83-852a-4492-b7f0-83579fecf1a2
NDC0006-4047
Product TypeVaccine
Proprietary NameRotaTeq
Generic NameRotavirus Vaccine, Live, Oral, Pentavalent
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2006-02-03
Marketing CategoryBLA / BLA
Application NumberBLA125122
Labeler NameMerck Sharp & Dohme Corp.
Substance NameHUMAN ROTAVIRUS A TYPE G1P7(5) STRAIN WI79 LIVE ANTIGEN; HUMAN ROTAVIRUS A TYPE G2P7(5) STRAIN SC2 LIVE ANTIGEN; HUMAN ROTAVIRUS A TYPE G3P7(5) STRAIN WI78 LIVE ANTIGEN; HUMAN ROTAVIRUS A TYPE G4P7(5) STRAIN BRB LIVE ANTIGEN; HUMAN ROTAVIRUS A TYPE G6P1A(8) STRAIN WI79 LIVE ANTIGEN
Active Ingredient Strength2200000 [iU]/2mL; [iU]/2mL; [iU]/2mL; [iU]/2mL; [iU]/2mL
Pharm ClassesLive Rotavirus Vaccine [EPC],Actively Acquired Immunity [PE],Rotavirus Vaccines [CS],Vaccines, Live, Unattenuated [CS],Live Rotavirus Vaccine [EPC],Actively Acquired Immunity [PE],Rotavirus Vaccines [CS],Vaccines, Live, Unattenuated [CS],Live Rotavirus Vaccine [EPC],Actively Acquired Immunity [PE],Rotavirus Vaccines [CS],Vaccines, Live, Unattenuated [CS],Live Rotavirus Vaccine [EPC],Actively Acquired Immunity [PE],Rotavirus Vaccines [CS],Vaccines, Live, Unattenuated [CS],Live Rotavirus Vaccine [EPC],Actively Acquired Immunity [PE],Rotavirus Vaccines [CS],Vaccines, Live, Unattenuated [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0006-4047-20

25 POUCH in 1 CARTON (0006-4047-20) > 1 TUBE in 1 POUCH (0006-4047-02) > 2 mL in 1 TUBE (0006-4047-01)
Marketing Start Date2006-02-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0006-4047-20 [00006404720]

RotaTeq SOLUTION
Marketing CategoryBLA
Application NumberBLA125122
Product TypeVACCINE
Billing UnitML
Marketing Start Date2010-12-13

NDC 0006-4047-01 [00006404701]

RotaTeq SOLUTION
Marketing CategoryBLA
Application NumberBLA125122
Product TypeVACCINE
Billing UnitML
Marketing Start Date2006-02-03

NDC 0006-4047-41 [00006404741]

RotaTeq SOLUTION
Marketing CategoryBLA
Application NumberBLA125122
Product TypeVACCINE
Billing UnitML
Marketing Start Date2006-02-03

Drug Details

Active Ingredients

IngredientStrength
HUMAN ROTAVIRUS A TYPE G1P7(5) STRAIN WI79 LIVE ANTIGEN2200000 [iU]/2mL

Pharmacological Class

  • Live Rotavirus Vaccine [EPC]
  • Actively Acquired Immunity [PE]
  • Rotavirus Vaccines [CS]
  • Vaccines
  • Live
  • Unattenuated [CS]
  • Live Rotavirus Vaccine [EPC]
  • Actively Acquired Immunity [PE]
  • Rotavirus Vaccines [CS]
  • Vaccines
  • Live
  • Unattenuated [CS]
  • Live Rotavirus Vaccine [EPC]
  • Actively Acquired Immunity [PE]
  • Rotavirus Vaccines [CS]
  • Vaccines
  • Live
  • Unattenuated [CS]
  • Live Rotavirus Vaccine [EPC]
  • Actively Acquired Immunity [PE]
  • Rotavirus Vaccines [CS]
  • Vaccines
  • Live
  • Unattenuated [CS]
  • Live Rotavirus Vaccine [EPC]
  • Actively Acquired Immunity [PE]
  • Rotavirus Vaccines [CS]
  • Vaccines
  • Live
  • Unattenuated [CS]

Trademark Results [RotaTeq]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ROTATEQ
ROTATEQ
76494554 not registered Dead/Abandoned
Merck & Co., Inc.
2003-03-04
ROTATEQ
ROTATEQ
75666657 2742325 Live/Registered
MERCK SHARP & DOHME CORP.
1999-03-24

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