FDA.reportPublic FDA data

NDC 63323-203-01 - 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
63323-203
Requested NDC
63323-203-01
Package NDCs from labels
63323-203-01, 63323-203-20, 63323-203-41, 63323-203-26
Manufacturer
Fresenius Kabi USA, LLC | Xellia Pharmaceuticals ApS | GLAND PHARMA LIMITED
Effective date
2025-05-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
VANCOMYCIN HYDROCHLORIDE - Fresenius Kabi USA, LLC | Xellia Pharmaceuticals ApS | GLAND PHARMA LIMITEDFresenius Kabi USA, LLC | Xellia Pharmaceuticals ApS | GLAND PHARMA LIMITED2025-05-15HUMAN PRESCRIPTION DRUG LABEL
Vancomycin Hydrochloride - Fresenius Kabi USA, LLCFresenius Kabi USA, LLC2025-03-17HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-203-01VANCOMYCIN HYDROCHLORIDE15 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,1517
63323-203-20VANCOMYCIN HYDROCHLORIDE10 in 1 TRAYINJECTION, POWDER, LYOPHILIZED,1017
63323-203-26Vancomycin Hydrochloride10 in 1 TRAYINJECTION, POWDER, LYOPHILIZED,104
63323-203-41Vancomycin Hydrochloride15 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,154

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-203VANCOMYCIN HYDROCHLORIDE (VANCOMYCIN HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC ]16Current NDC, Legacy NDC, 2 package rows20240328_f604d399-fded-4f4f-8efe-af558ed07b9d.zip
63323-203VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]4Current NDC, Legacy NDC, 2 package rows20250501_9bfe30f8-c662-4af3-bc82-f0102eef8952.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-203-01EA - Each63323-203cdd00921-61cf-411b-a975-57d514a952ef12024-09-09
63323-203-20EA - Each63323-203a0c89ca3-edcf-4660-ac95-437390d0169e12016-11-08
63323-203-26EA - Each63323-203d4c2b3cb-c399-4a96-939b-b07a8625128912018-06-11
63323-203-41EA - Each63323-20321473ee7-3cab-48bc-92ce-44f12d707d0f12018-06-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VANCOMYCIN HYDROCHLORIDEACTIVE INGREDIENT71WO621TJDVANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [APP PHARMACEUTICALS, LLC]3
VANCOMYCINACTIVE MOIETY6Q205EH1VUVANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [APP PHARMACEUTICALS, LLC]3

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
application number: ANDA062663
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEFresenius Kabi, LLC8a35ebee-8650-4ef5-84f5-ab9b55d9bc192022-12-02Warnings, Adverse reactionsExact identifier
application number: ANDA204107
ndc (product): 63323-221
rxcui: 1807516
spl id: 0ab54d7b-de6b-412f-b2b5-a8522f78f3c4
spl set id: 8a35ebee-8650-4ef5-84f5-ab9b55d9bc19
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEFresenius Kabi, LLC418c3c6a-d08d-448c-89c9-54e558c1ce162022-12-02Warnings, Adverse reactionsExact identifier
application number: ANDA204107
ndc (product): 63323-221
ndc (product): 63323-284
rxcui: 1807513
rxcui: 1807516
spl id: 23a89459-d331-4975-84fe-4bfa6ed2c24e
spl set id: 418c3c6a-d08d-448c-89c9-54e558c1ce16
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
rxcui: 1807516
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEHikma Pharmaceuticals USA Inc.86950e7c-0114-47e9-8891-e09e595c48c32022-02-25Warnings, Adverse reactionsExact identifier
rxcui: 1807518
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
application number: ANDA062663
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
rxcui: 1807516
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEMylan Institutional LLC2dc7b3d6-3874-40ac-b8aa-7bcfe2dc0cdf2021-06-01Warnings, Adverse reactionsExact identifier
rxcui: 1807513
rxcui: 1807516
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.