FDA.reportPublic FDA data

NDC 31722-210-33 - 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
31722-210
Requested NDC
31722-210-33
Package NDCs from labels
31722-210-33, 31722-210-32, 31722-210-10
Manufacturer
Camber Pharmaceuticals, Inc. | Aspiro Pharma Limited
Effective date
2022-07-20
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
VANCOMYCIN HYDROCHLORIDE - Camber Pharmaceuticals, Inc. | Aspiro Pharma LimitedCamber Pharmaceuticals, Inc. | Aspiro Pharma Limited2022-07-20HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
31722-210-10VANCOMYCIN HYDROCHLORIDE10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,101
31722-210-32VANCOMYCIN HYDROCHLORIDE25 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,251
31722-210-33VANCOMYCIN HYDROCHLORIDE10 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-210VANCOMYCIN HYDROCHLORIDE (VANCOMYCIN HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CAMBER PHARMACEUTICALS, INC.]1Current NDC, Legacy NDC, 3 package rows20220722_3f5dacea-af40-4103-b128-c5e0c0c52fa1.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-210-10EA - Each31722-210a927ce31-0941-4eb0-bfe7-4623c71ce90812023-02-06

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 · 73 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
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEFresenius Kabi, LLC8a35ebee-8650-4ef5-84f5-ab9b55d9bc192022-12-02Warnings, Adverse reactionsExact identifier
rxcui: 1807516
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEFresenius Kabi, LLC418c3c6a-d08d-448c-89c9-54e558c1ce162022-12-02Warnings, Adverse reactionsExact identifier
rxcui: 1807513
rxcui: 1807516
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
application number: ANDA216591
ndc (package): 31722-210-33
ndc (package): 31722-211-10
ndc (package): 31722-210-10
ndc (package): 31722-211-33
ndc (package): 31722-210-32
ndc (product): 31722-211
ndc (product): 31722-210
ndc11 (package): 31722021033
rxcui: 1807513
rxcui: 1807516
spl id: e449bca2-14c8-ae21-e053-2a95a90a942b
spl set id: 3f5dacea-af40-4103-b128-c5e0c0c52fa1
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
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.