FDA.reportPublic FDA data

NDC 43538-805-01 - 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
43538-805
Requested NDC
43538-805-01
Package NDCs from labels
43538-805-01, 43538-805-10
Manufacturer
Eurofarma, Inc. | Eurofarma Laboratorios S/A
Effective date
2026-06-12
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Vancomycin Hydrochloride - Eurofarma, Inc. | Eurofarma Laboratorios S/AEurofarma, Inc. | Eurofarma Laboratorios S/A2026-06-12HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43538-805-01Vancomycin Hydrochloride10 mL in 1 VIAL, GLASSINJECTION, POWDER, LYOPHILIZED,101
43538-805-10Vancomycin Hydrochloride10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43538-805VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MEDIMETRIKS PHARMACEUTICALS, INC.]1Current NDC, 2 package rows20250411_826510bd-b611-42d9-a574-ec7ee4151ef5.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43538-805-01EA - Each43538-8057e86d4e2-e0e7-4ee8-ad2a-7815f12466e912025-11-13
43538-805-10EA - Each43538-80545c50085-9bb3-4043-820e-0f6509f86d6512025-11-13

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 1 of 4 · 73 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDECameron Pharmaceuticalsbc737938-ae36-460b-a2a8-609f3fe591562026-08-17Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD
vancomycin hydrochlorideVANCOMYCIN HYDROCHLORIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.127d95d1-8070-41ac-8343-3168b0cf13122026-08-05Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEAvenacy, LLCc757e65b-ca6f-4c00-afe2-025962b43d312026-07-31Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD
vancomycin hydrochlorideVANCOMYCIN HYDROCHLORIDERedpharm Drug57d23aed-a3f7-f92e-e063-6394a90add7d2026-07-30Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEHospira, Inc.b01aaa02-8f1d-4b57-96a5-337503428af12026-07-20Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEMeitheal Pharmaceuticals Inc.033efc76-11d5-4a93-91de-56ed41bab9c32026-07-08Warnings, Adverse reactionsExact identifier
rxcui: 1807513
rxcui: 1807516
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEBryant Ranch Prepack7bbd2c81-33d9-4397-8795-8b9fa28cb5cf2026-06-26Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEBryant Ranch Prepackd6b8147b-5f93-49ee-8b27-78fe58987c902026-06-26Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEBryant Ranch Prepack28fe3c01-cf87-41c0-87fd-f93a405243352026-06-16Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEEurofarma, Inc.826510bd-b611-42d9-a574-ec7ee4151ef52026-06-12Warnings, Adverse reactionsExact identifier
application number: ANDA065401
ndc (package): 43538-805-01
ndc (package): 43538-810-01
ndc (package): 43538-805-10
ndc (package): 43538-810-10
ndc (product): 43538-810
ndc (product): 43538-805
ndc11 (package): 43538080501
rxcui: 1807513
rxcui: 1807516
spl id: 18b06c9d-a2d4-4495-93c8-b6e42294eb2c
spl set id: 826510bd-b611-42d9-a574-ec7ee4151ef5
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEBryant Ranch Prepack6c74b360-022a-4c4d-9e4b-0988219a78fb2026-06-12Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEBryant Ranch Prepack8193f588-a032-451e-a0a1-819a5ea834c82026-06-12Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD
VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDEBaxter Healthcare Corporation99e523d8-9bde-43cb-8434-497015e5dcbd2026-06-09Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEBryant Ranch Prepacka09c589b-e7f4-457c-827f-e1bfa1b267002026-05-26Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEBryant Ranch Prepack786bde33-9aec-4b4d-ba46-90bfd61956d02026-05-26Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEBryant Ranch Prepack9b6a7a21-4fde-40c6-a420-a8546a4dc7012026-05-26Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD
VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDESlate Run Pharmaceuticals, LLC6ea38b4d-a6d2-4826-8110-ae42c9f7a42a2026-05-15Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD
VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDESlate Run Pharmaceuticals, LLC57f58371-3ce6-4983-89df-acba33d1139a2026-05-15Warnings, Adverse reactionsExact identifier
rxcui: 1807513
rxcui: 1807516
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEGLENMARK PHARMACEUTICALS INC., USA74056e26-57fd-448e-af76-edbccfc3efb72026-04-07Warnings, Adverse reactionsExact identifier
rxcui: 1807513
rxcui: 1807516
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDECivica, Inc3e041ec6-811b-4f26-9303-959cb09d5f572026-04-02Warnings, Adverse reactionsExact identifier
rxcui: 1807513
unii: 71WO621TJD

Reported adverse events (FAERS/openFDA)#

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