FDA.reportPublic FDA data

NDC 0006-4047-01 - RotaTeq

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0006-4047
Requested NDC
0006-4047-01
Package NDCs from labels
0006-4047-01, 0006-4047-02, 0006-4047-41, 0006-4047-20
Manufacturer
Merck Sharp & Dohme LLC
Effective date
2026-05-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
RotaTeq - Merck Sharp & Dohme LLCMerck Sharp & Dohme LLC2026-05-15VACCINE LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-02-13Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0006-4047-01RotaTeq2 mL in 1 TUBESOLUTION247
0006-4047-02RotaTeq1 in 1 POUCHSOLUTION147
0006-4047-20RotaTeq25 in 1 CARTONSOLUTION2547
0006-4047-41RotaTeq10 in 1 CARTONSOLUTION1047

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0006-4047ROTATEQ (ROTAVIRUS VACCINE, LIVE, ORAL, PENTAVALENT) SOLUTION [MERCK SHARP & DOHME LLC]42Current NDC, Legacy NDC, 4 package rows20241114_aaf3b24e-85fd-43ee-b657-2ee4df312ec3.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0006-4047-01ML - Milliliter0006-4047ae510f35-e8cc-4521-a4d1-15d64cd8a45912013-02-13
0006-4047-02ML - Milliliter0006-4047ef40289c-553c-48f6-9494-e396677319d112021-12-08
0006-4047-20ML - Milliliter0006-404730ab1b0b-884a-4502-8026-b17299e7b6fb12013-02-13
0006-4047-41ML - Milliliter0006-4047e12a2263-e33a-4d8d-9632-68b243a56bdd12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HUMAN ROTAVIRUS A TYPE G1P7(5) STRAIN WI79 LIVE ANTIGENACTIVE INGREDIENT25VC15141QROTATEQ (ROTAVIRUS VACCINE, LIVE, ORAL, PENTAVALENT) SOLUTION [MERCK SHARP & DOHME CORP.]27
HUMAN ROTAVIRUS A TYPE G2P7(5) STRAIN SC2 LIVE ANTIGENACTIVE INGREDIENTJU499IS53HROTATEQ (ROTAVIRUS VACCINE, LIVE, ORAL, PENTAVALENT) SOLUTION [MERCK SHARP & DOHME CORP.]27
HUMAN ROTAVIRUS A TYPE G3P7(5) STRAIN WI78 LIVE ANTIGENACTIVE INGREDIENT236YGP181OROTATEQ (ROTAVIRUS VACCINE, LIVE, ORAL, PENTAVALENT) SOLUTION [MERCK SHARP & DOHME CORP.]27
HUMAN ROTAVIRUS A TYPE G4P7(5) STRAIN BRB LIVE ANTIGENACTIVE INGREDIENT6334XMP4KCROTATEQ (ROTAVIRUS VACCINE, LIVE, ORAL, PENTAVALENT) SOLUTION [MERCK SHARP & DOHME CORP.]27
HUMAN ROTAVIRUS A TYPE G6P1A(8) STRAIN WI79 LIVE ANTIGENACTIVE INGREDIENTL1977Q86S5ROTATEQ (ROTAVIRUS VACCINE, LIVE, ORAL, PENTAVALENT) SOLUTION [MERCK SHARP & DOHME CORP.]27
HUMAN ROTAVIRUS A TYPE G1P7(5) STRAIN WI79 LIVE ANTIGENACTIVE MOIETY25VC15141QROTATEQ (ROTAVIRUS VACCINE, LIVE, ORAL, PENTAVALENT) SOLUTION [MERCK SHARP & DOHME CORP.]27
HUMAN ROTAVIRUS A TYPE G2P7(5) STRAIN SC2 LIVE ANTIGENACTIVE MOIETYJU499IS53HROTATEQ (ROTAVIRUS VACCINE, LIVE, ORAL, PENTAVALENT) SOLUTION [MERCK SHARP & DOHME CORP.]27
HUMAN ROTAVIRUS A TYPE G3P7(5) STRAIN WI78 LIVE ANTIGENACTIVE MOIETY236YGP181OROTATEQ (ROTAVIRUS VACCINE, LIVE, ORAL, PENTAVALENT) SOLUTION [MERCK SHARP & DOHME CORP.]27
HUMAN ROTAVIRUS A TYPE G4P7(5) STRAIN BRB LIVE ANTIGENACTIVE MOIETY6334XMP4KCROTATEQ (ROTAVIRUS VACCINE, LIVE, ORAL, PENTAVALENT) SOLUTION [MERCK SHARP & DOHME CORP.]27
HUMAN ROTAVIRUS A TYPE G6P1A(8) STRAIN WI79 LIVE ANTIGENACTIVE MOIETYL1977Q86S5ROTATEQ (ROTAVIRUS VACCINE, LIVE, ORAL, PENTAVALENT) SOLUTION [MERCK SHARP & DOHME CORP.]27
ALBUMIN BOVINEINACTIVE INGREDIENT27432CM55QROTATEQ (ROTAVIRUS VACCINE, LIVE, ORAL, PENTAVALENT) SOLUTION [MERCK SHARP & DOHME CORP.]27
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HROTATEQ (ROTAVIRUS VACCINE, LIVE, ORAL, PENTAVALENT) SOLUTION [MERCK SHARP & DOHME CORP.]27
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRROTATEQ (ROTAVIRUS VACCINE, LIVE, ORAL, PENTAVALENT) SOLUTION [MERCK SHARP & DOHME CORP.]27
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IROTATEQ (ROTAVIRUS VACCINE, LIVE, ORAL, PENTAVALENT) SOLUTION [MERCK SHARP & DOHME CORP.]27
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEINACTIVE INGREDIENT593YOG76RNROTATEQ (ROTAVIRUS VACCINE, LIVE, ORAL, PENTAVALENT) SOLUTION [MERCK SHARP & DOHME CORP.]27
SUCROSEINACTIVE INGREDIENTC151H8M554ROTATEQ (ROTAVIRUS VACCINE, LIVE, ORAL, PENTAVALENT) SOLUTION [MERCK SHARP & DOHME CORP.]27

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 7 of 7 · 130 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINEFenwal, Inc.ee831456-5962-4d5e-ad0c-69ab858604532020-06-03Exact identifier
unii: 593YOG76RN
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINEFenwal, Inc.e41adb4e-06fb-4141-ba55-50b043f3c9da2019-11-19Exact identifier
unii: 593YOG76RN
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINEFenwal, Inc.14445dfd-6041-40cd-a043-3f4da6bcb9c12019-11-18Exact identifier
unii: 593YOG76RN
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINEFenwal, Inc.2557199a-5f60-49d8-b093-1e07002112432019-11-18Exact identifier
unii: 593YOG76RN
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINEFenwal, Inc.794f724c-87f0-49c1-9b26-c9e4919783132019-11-18Exact identifier
unii: 593YOG76RN
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINEFenwal, Inc.5c7d3287-883a-459b-9214-074a583c8a592019-11-18Exact identifier
unii: 593YOG76RN
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINEFenwal, Inc.448a1dc5-7a98-4b2f-82af-4b92de05cfc32019-11-18Exact identifier
unii: 593YOG76RN
AdditoxTRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BELLADONNA, CHELIDONIUM MAJUS, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMBioActive Nutritional, Inc.319ee2fe-58e3-495e-bf0d-df201f6fbb1c2018-07-18WarningsExact identifier
unii: 1Q73Q2JULR
URELLEHYOSCYAMINE SULFATE, METHENAMINE, METHYLENE BLUE, PHENYL SALICYLATE, AND SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEViatris Specialty LLC1d80a11c-6f86-403b-85d4-32ec1924dbe92015-01-13Warnings, Adverse reactionsExact identifier
unii: 593YOG76RN
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINEFenwal, Inc.051f7347-5a76-4664-8fe2-e61b3dfcb0e42014-08-27Exact identifier
unii: 593YOG76RN

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.