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 ID: 0006-4047_05a6cc83-852a-4492-b7f0-83579fecf1a2
• NDC: 0006-4047
• Product Type: Vaccine
• Proprietary Name: RotaTeq
• Generic Name: Rotavirus Vaccine, Live, Oral, Pentavalent
• Dosage Form: Solution
• Route of Administration: ORAL
• Marketing Start Date: 2006-02-03
• Marketing Category: BLA / BLA
• Application Number: BLA125122
• Labeler Name: Merck Sharp & Dohme Corp.
• Substance Name: 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
• Active Ingredient Strength: 2200000 [iU]/2mL; [iU]/2mL; [iU]/2mL; [iU]/2mL; [iU]/2mL
• Pharm Classes: 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]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

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 Date: 2006-02-03
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0006-4047-20 [00006404720]

RotaTeq SOLUTION

• Marketing Category: BLA
• Application Number: BLA125122
• Product Type: VACCINE
• Billing Unit: ML
• Marketing Start Date: 2010-12-13

NDC 0006-4047-01 [00006404701]

RotaTeq SOLUTION

• Marketing Category: BLA
• Application Number: BLA125122
• Product Type: VACCINE
• Billing Unit: ML
• Marketing Start Date: 2006-02-03

NDC 0006-4047-41 [00006404741]

RotaTeq SOLUTION

• Marketing Category: BLA
• Application Number: BLA125122
• Product Type: VACCINE
• Billing Unit: ML
• Marketing Start Date: 2006-02-03

Drug Details

Active Ingredients

Ingredient	Strength
HUMAN ROTAVIRUS A TYPE G1P7(5) STRAIN WI79 LIVE ANTIGEN	2200000 [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]