FDA.reportPublic FDA data

NDC 0005-2000-01 - Prevnar 20

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
0005-2000
Requested NDC
0005-2000-01
Package NDCs from labels
0005-2000-01, 0005-2000-10, 0005-2000-02
Manufacturer
Wyeth Pharmaceutical Division of Wyeth Holdings LLC | Pfizer Ireland Pharmaceuticals Unlimited Company | Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC | Pfizer Manufacturing Belgium NV | Pfizer Inc
Effective date
2026-07-24
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Prevnar 20Wyeth Pharmaceutical Division of Wyeth Holdings LLC | Pfizer Ireland Pharmaceuticals Unlimited Company | Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC | Pfizer Manufacturing Belgium NV | Pfizer Inc2026-07-24VACCINE LABEL
PREVNAR 20 - A-S Medication SolutionsA-S Medication Solutions2025-08-13VACCINE LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
0005-2000-02These highlights do not include all the information needed to use PREVNAR 20 safely and effectively. See full prescribing information for PREVNAR 20. PREVNAR 20 ® (Pneumococcal 20-valent Conjugate Vaccine), suspension for intramuscular injection Initial U.S. Approval: 2021
0005-2000-02These highlights do not include all the information needed to use PREVNAR 20 safely and effectively. See full prescribing information for PREVNAR 20. PREVNAR 20 ® (Pneumococcal 20-valent Conjugate Vaccine), suspension for intramuscular injection Initial U.S. Approval: 2021
0005-2000-10These highlights do not include all the information needed to use PREVNAR 20 safely and effectively. See full prescribing information for PREVNAR 20. PREVNAR 20 ® (Pneumococcal 20-valent Conjugate Vaccine), suspension for intramuscular injection Initial U.S. Approval: 2021
0005-2000-10These highlights do not include all the information needed to use PREVNAR 20 safely and effectively. See full prescribing information for PREVNAR 20. PREVNAR 20 ® (Pneumococcal 20-valent Conjugate Vaccine), suspension for intramuscular injection Initial U.S. Approval: 2021

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0005-2000-01Prevnar 200.5 mL in 1 SYRINGEINJECTION, SUSPENSION0.511
0005-2000-02Prevnar 201 in 1 CARTONINJECTION, SUSPENSION111
0005-2000-10Prevnar 2010 in 1 CARTONINJECTION, SUSPENSION1011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0005-2000PREVNAR 20 (PNEUMOCOCCAL 20-VALENT CONJUGATE VACCINE) INJECTION, SUSPENSION [WYETH PHARMACEUTICAL DIVISION OF WYETH HOLDINGS LLC]9Current NDC, Legacy NDC, 3 package rows20250420_d4e2cf51-e6a8-4103-bb1d-6120c6474ff8.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0005-2000-01ML - Milliliter0005-2000d7dd374c-b775-4d30-b57f-a8426e6a3a9812022-05-04
0005-2000-02ML - Milliliter0005-200006be0ba0-a57b-447a-bdd1-abb7148d062712021-08-05
0005-2000-10ML - Milliliter0005-20004ea1d2e7-01de-4d43-9a9f-439eb7856e8812021-08-05

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 44 of 44 · 866 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tox-ChordALFALFA, ALUMINA, BENZOICUM ACIDUM, CARBONEUM, CETRARIA ISLANDICA, FOLLICULINUM, FUCUS VESICULOSUS, FUMARICUM ACIDUM, HEPAR SUIS, KALI CARBONICUM, KREOSOTUM, NATRUM MURIATICUM, PARAFFINUM, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PIX LIQUIDA, PLANTAGO MAJOR, PLUMBUM METALLICUM, PULSATILLA (VULGARIS), RADIUM BROMATUM, RESORCINUM, SALOL, SILICEA, SYMPHYTUM OFFICINALE, TABACUM, TEREBINTHINA, THYROIDINUM (BOVINE), TRITICUM REPENS, ZINCUM OXYDATUMEnergetix Corp6b0d1628-b20d-426e-9c84-5cceadca3f452016-11-11WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEBaxter Healthcare Corporation2a96096d-43cc-49b7-af53-b53c17f410012014-07-25Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
SODIUM CHLORIDESODIUM CHLORIDEBaxter Healthcare Corporationb3b4b176-41f0-4ca8-90d4-3fba5707564a2014-02-21Exact identifier
unii: 451W47IQ8X
TIS-U-SOLSODIUM CHLORIDE, POTASSIUM CHLORIDE, MAGNESIUM SULFATE, SODIUM PHOSPHATE, AND POTASSIUM PHOSPHATEBaxter Healthcare Corporation9da4121f-d62d-4da4-8dfb-0494da16015f2014-02-21Exact identifier
unii: 451W47IQ8X
RingersSODIUM CHLORIDE, CALCIUM CHLORIDE, POTASSIUM CHLORIDE,Baxter Healthcare Corporatione1953d54-818d-46a6-8532-518ebae6d84e2012-06-13Exact identifier
unii: 451W47IQ8X
Lactated RingersSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDEBaxter Healthcare Corporationf09f80bf-2f8b-4420-865d-aec2d5e5cd4d2012-06-12Exact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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