FDA.reportPublic FDA data

NDC 72572-801-01 - Vancomycin Hydrochloride

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
72572-801
Requested NDC
72572-801-01
Package NDCs from labels
72572-801-01, 72572-801-02
Manufacturer
Civica, Inc. | Xellia Pharmaceuticals ApS
Effective date
2023-02-03
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Vancomycin Hydrochloride - Civica, Inc. | Xellia Pharmaceuticals ApSCivica, Inc. | Xellia Pharmaceuticals ApS2023-02-03HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72572-801-022025-07-29C16284748780-13b156c62-25f7-fb37-e063-e6dba90a4e07Vancomycin Hydrochloride for Injection, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72572-801-01Vancomycin Hydrochloride10 mL in 1 VIAL, GLASSINJECTION, POWDER, LYOPHILIZED,108
72572-801-02Vancomycin Hydrochloride10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,108

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72572-801VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CIVICA, INC.]8Legacy NDC, 2 package rows20231101_59b2c4fc-db5e-4a92-84c7-e760d009c19e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72572-801-01EA - Each72572-801bc0b2498-2963-46e3-872d-d31781ac2f3912019-09-05
72572-801-02EA - Each72572-801f0af7a6a-10df-4479-8e12-cdf1e156da3212019-09-05

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 4 of 4 · 74 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEFresenius Kabi USA, LLC0713a847-a334-4b73-af22-343aa06621b92023-02-07Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD
a44fa817-9955-4e31-8626-39b9c84999a759b2c4fc-db5e-4a92-84c7-e760d009c19e2023-02-03Warnings, Adverse reactionsExact identifier
spl id: a44fa817-9955-4e31-8626-39b9c84999a7
spl set id: 59b2c4fc-db5e-4a92-84c7-e760d009c19e
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEFresenius Kabi, LLC8a35ebee-8650-4ef5-84f5-ab9b55d9bc192022-12-02Warnings, Adverse reactionsExact identifier
application number: ANDA204107
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEFresenius Kabi, LLC418c3c6a-d08d-448c-89c9-54e558c1ce162022-12-02Warnings, Adverse reactionsExact identifier
application number: ANDA204107
rxcui: 1807513
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEBluePoint Laboratoriesf28e3c2b-ae31-4c2a-8178-53962b7b213c2022-09-22Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD
VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDECamber Pharmaceuticals, Inc.3f5dacea-af40-4103-b128-c5e0c0c52fa12022-07-20Warnings, Adverse reactionsExact identifier
rxcui: 1807513
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEHikma Pharmaceuticals USA Inc.cae9e5f3-b89a-4a7f-93f7-9471c74a35592021-12-07Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEFresenius Kabi USA, LLCd3147f2d-1a72-4923-874b-8fdee2be625e2021-09-30Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEMylan Institutional LLCce139a51-0471-4c31-b456-2f889f18dd2b2021-09-15Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEHikma Pharmaceuticals USA Inc.2f5d3131-8ddc-43a5-91f7-947c531796e72021-06-02Warnings, Adverse reactionsExact identifier
rxcui: 1807513
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEMylan Institutional LLC2dc7b3d6-3874-40ac-b8aa-7bcfe2dc0cdf2021-06-01Warnings, Adverse reactionsExact identifier
rxcui: 1807513
unii: 71WO621TJD
vancomycin hydrochlorideVANCOMYCIN HYDROCHLORIDEMylan Institutional LLC3843d0d7-f70a-4b29-9478-dfb45b02425e2021-06-01Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDESAMSON MEDICAL TECHNOLOGIES LLC93589e71-3a11-4797-9176-8abdb7674a872020-11-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEFresenius Kabi, LLCa7e7d990-1d74-459b-ac07-d1c3e13b32042019-01-09Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD

Reported adverse events (FAERS/openFDA)#

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