Home NDC 0006-4047 RotaTeq
Product NDC 0006-4047
11-digit product format 000064047
Labeler code 0006
Product ID 0006-4047_4782ba3a-5abf-43b0-a235-3cf141176ff1
Type VACCINE
Nonproprietary name Rotavirus Vaccine, Live, Oral, Pentavalent
Dosage form SOLUTION
Route ORAL
Labeler Merck Sharp & Dohme LLC
Application BLA125122
Marketing category BLA
Marketing start 2006-02-03
Substance 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 strength 2200000; 2800000; 2200000; 2000000; 2300000 [iU]/2mL; [iU]/2mL; [iU]/2mL; [iU]/2mL; [iU]/2mL
Pharmacologic classes Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Live Rotavirus Vaccine [EPC], Live Rotavirus Vaccine [EPC], Live Rotavirus Vaccine [EPC], Live Rotavirus Vaccine [EPC], Live Rotavirus Vaccine [EPC], Rotavirus Vaccines [CS], Rotavirus Vaccines [CS], Rotavirus Vaccines [CS], Rotavirus Vaccines [CS], Rotavirus Vaccines [CS], Vaccines, Live, Unattenuated [CS], Vaccines, Live, Unattenuated [CS], Vaccines, Live, Unattenuated [CS], Vaccines, Live, Unattenuated [CS], Vaccines, Live, Unattenuated [CS]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base RotaTeq
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HUMAN ROTAVIRUS A TYPE G1P7(5) STRAIN WI79 LIVE ANTIGEN 2200000 [iU]/2mL HUMAN ROTAVIRUS A TYPE G2P7(5) STRAIN SC2 LIVE ANTIGEN 2800000 [iU]/2mL HUMAN ROTAVIRUS A TYPE G3P7(5) STRAIN WI78 LIVE ANTIGEN 2200000 [iU]/2mL HUMAN ROTAVIRUS A TYPE G4P7(5) STRAIN BRB LIVE ANTIGEN 2000000 [iU]/2mL HUMAN ROTAVIRUS A TYPE G6P1A(8) STRAIN WI79 LIVE ANTIGEN 2300000 [iU]/2mL
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded HUMAN ROTAVIRUS A TYPE G1P7(5) STRAIN WI79 LIVE ANTIGEN ACTIVE INGREDIENT 25VC15141Q ROTATEQ (ROTAVIRUS VACCINE, LIVE, ORAL, PENTAVALENT) SOLUTION [MERCK SHARP & DOHME CORP.] 27 HUMAN ROTAVIRUS A TYPE G2P7(5) STRAIN SC2 LIVE ANTIGEN ACTIVE INGREDIENT JU499IS53H ROTATEQ (ROTAVIRUS VACCINE, LIVE, ORAL, PENTAVALENT) SOLUTION [MERCK SHARP & DOHME CORP.] 27 HUMAN ROTAVIRUS A TYPE G3P7(5) STRAIN WI78 LIVE ANTIGEN ACTIVE INGREDIENT 236YGP181O ROTATEQ (ROTAVIRUS VACCINE, LIVE, ORAL, PENTAVALENT) SOLUTION [MERCK SHARP & DOHME CORP.] 27 HUMAN ROTAVIRUS A TYPE G4P7(5) STRAIN BRB LIVE ANTIGEN ACTIVE INGREDIENT 6334XMP4KC ROTATEQ (ROTAVIRUS VACCINE, LIVE, ORAL, PENTAVALENT) SOLUTION [MERCK SHARP & DOHME CORP.] 27 HUMAN ROTAVIRUS A TYPE G6P1A(8) STRAIN WI79 LIVE ANTIGEN ACTIVE INGREDIENT L1977Q86S5 ROTATEQ (ROTAVIRUS VACCINE, LIVE, ORAL, PENTAVALENT) SOLUTION [MERCK SHARP & DOHME CORP.] 27 HUMAN ROTAVIRUS A TYPE G1P7(5) STRAIN WI79 LIVE ANTIGEN ACTIVE MOIETY 25VC15141Q ROTATEQ (ROTAVIRUS VACCINE, LIVE, ORAL, PENTAVALENT) SOLUTION [MERCK SHARP & DOHME CORP.] 27 HUMAN ROTAVIRUS A TYPE G2P7(5) STRAIN SC2 LIVE ANTIGEN ACTIVE MOIETY JU499IS53H ROTATEQ (ROTAVIRUS VACCINE, LIVE, ORAL, PENTAVALENT) SOLUTION [MERCK SHARP & DOHME CORP.] 27 HUMAN ROTAVIRUS A TYPE G3P7(5) STRAIN WI78 LIVE ANTIGEN ACTIVE MOIETY 236YGP181O ROTATEQ (ROTAVIRUS VACCINE, LIVE, ORAL, PENTAVALENT) SOLUTION [MERCK SHARP & DOHME CORP.] 27 HUMAN ROTAVIRUS A TYPE G4P7(5) STRAIN BRB LIVE ANTIGEN ACTIVE MOIETY 6334XMP4KC ROTATEQ (ROTAVIRUS VACCINE, LIVE, ORAL, PENTAVALENT) SOLUTION [MERCK SHARP & DOHME CORP.] 27 HUMAN ROTAVIRUS A TYPE G6P1A(8) STRAIN WI79 LIVE ANTIGEN ACTIVE MOIETY L1977Q86S5 ROTATEQ (ROTAVIRUS VACCINE, LIVE, ORAL, PENTAVALENT) SOLUTION [MERCK SHARP & DOHME CORP.] 27 ALBUMIN BOVINE INACTIVE INGREDIENT 27432CM55Q ROTATEQ (ROTAVIRUS VACCINE, LIVE, ORAL, PENTAVALENT) SOLUTION [MERCK SHARP & DOHME CORP.] 27 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H ROTATEQ (ROTAVIRUS VACCINE, LIVE, ORAL, PENTAVALENT) SOLUTION [MERCK SHARP & DOHME CORP.] 27 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR ROTATEQ (ROTAVIRUS VACCINE, LIVE, ORAL, PENTAVALENT) SOLUTION [MERCK SHARP & DOHME CORP.] 27 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I ROTATEQ (ROTAVIRUS VACCINE, LIVE, ORAL, PENTAVALENT) SOLUTION [MERCK SHARP & DOHME CORP.] 27 SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE INACTIVE INGREDIENT 593YOG76RN ROTATEQ (ROTAVIRUS VACCINE, LIVE, ORAL, PENTAVALENT) SOLUTION [MERCK SHARP & DOHME CORP.] 27 SUCROSE INACTIVE INGREDIENT C151H8M554 ROTATEQ (ROTAVIRUS VACCINE, LIVE, ORAL, PENTAVALENT) SOLUTION [MERCK SHARP & DOHME CORP.] 27
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0006-4047 ROTATEQ (ROTAVIRUS VACCINE, LIVE, ORAL, PENTAVALENT) SOLUTION [MERCK SHARP & DOHME LLC] 42 Current NDC, Legacy NDC, 4 package rows 20241114_aaf3b24e-85fd-43ee-b657-2ee4df312ec3.zip
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 798300 RotaTeq, Rotavirus, live pentavalent (RV5) Oral Vaccine PSN aaf3b24e-85fd-43ee-b657-2ee4df312ec3 48 798297 rotavirus, live pentavalent (RV5) Oral Vaccine PSN aaf3b24e-85fd-43ee-b657-2ee4df312ec3 48 798300 human-bovine reassortant rotavirus strain G1 vaccine 1100000 UNT/ML / human-bovine reassortant rotavirus strain G2 vaccine 1400000 UNT/ML / human-bovine reassortant rotavirus strain G3 vaccine 1100000 UNT/ML / human-bovine reassortant rotavirus strain G4 vaccine 1000000 UNT/ML / human-bovine reassortant rotavirus strain P1A[8] vaccine 1150000 UNT/ML Oral Suspension [RotaTeq] SBD aaf3b24e-85fd-43ee-b657-2ee4df312ec3 48 798297 human-bovine reassortant rotavirus strain G1 vaccine 1100000 UNT/ML / human-bovine reassortant rotavirus strain G2 vaccine 1400000 UNT/ML / human-bovine reassortant rotavirus strain G3 vaccine 1100000 UNT/ML / human-bovine reassortant rotavirus strain G4 vaccine 1000000 UNT/ML / human-bovine reassortant rotavirus strain P1A[8] vaccine 1150000 UNT/ML Oral Suspension SCD aaf3b24e-85fd-43ee-b657-2ee4df312ec3 48 798300 RotaTeq, Rotavirus, live pentavalent (RV5) Oral Vaccine SY aaf3b24e-85fd-43ee-b657-2ee4df312ec3 48 798297 rotavirus, live pentavalent (RV5) Oral Vaccine SY aaf3b24e-85fd-43ee-b657-2ee4df312ec3 48
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0006-4047-01 00006404701 2 mL in 1 TUBE 2 ml Historical 0006-4047-02 00006404702 1 in 1 POUCH Historical 0006-4047-20 00006404720 25 POUCH in 1 CARTON (0006-4047-20) / 1 TUBE in 1 POUCH (0006-4047-02) / 2 mL in 1 TUBE (0006-4047-01) 25 pouch 2006-02-03 0000-00-00 No No Current 0006-4047-41 00006404741 10 POUCH in 1 CARTON (0006-4047-41) / 1 TUBE in 1 POUCH (0006-4047-02) / 2 mL in 1 TUBE (0006-4047-01) 10 pouch 2006-02-03 0000-00-00 No No Current