FDA.reportPublic FDA data

Vancomycin Hydrochloride

Product NDC
63323-221
11-digit product format
633230221
Labeler code
63323
Product ID
63323-221_0ab54d7b-de6b-412f-b2b5-a8522f78f3c4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Vancomycin Hydrochloride
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Fresenius Kabi, LLC
Application
ANDA204107
Marketing category
ANDA
Marketing start
2017-11-01
Substance
VANCOMYCIN HYDROCHLORIDE
Active strength
500 mg/10mL
Pharmacologic classes
Glycopeptide Antibacterial [EPC], Glycopeptides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Vancomycin Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VANCOMYCIN HYDROCHLORIDE500 mg/10mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii71WO621TJD
Rxcui1807516

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
518d3e87-1791-43fd-b421-7f508923e5f1Product name420260107
8c6bdc15-c879-407f-914d-b44fce8e7bbdProduct name120240730
324cd4ef-8967-4991-91fd-3046d51874b9Product name220240118
ba2497d8-e8e9-d71b-251e-24ac323bbaa3Product name920231206
01f96903-8ada-4a91-9a58-9f8e51b7a70aProduct name120230922
e5c5573a-2fda-453b-9d65-c6185b588ecdProduct name520220613
3a86dfd0-ed28-4976-b9ec-00923fbfbdd4Product name120220308
5d603187-d384-6e74-5fc7-30310b2b3c99Product name320190717
bec007f0-8cd6-4f79-a3df-c0d94ebb2a36Product name120190614
f4fec0bc-aaaa-4c5c-aa2b-21daf18ef477Product name120160209
a0c54c75-e1f1-eb4f-25c4-be91c2fe237dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-221-01VANCOMYCIN HYDROCHLORIDE10 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,1017
63323-221-10VANCOMYCIN HYDROCHLORIDE25 in 1 TRAYINJECTION, POWDER, LYOPHILIZED,2517
63323-221-16VANCOMYCIN HYDROCHLORIDE25 in 1 TRAYINJECTION, POWDER, LYOPHILIZED,258
63323-221-41VANCOMYCIN HYDROCHLORIDE10 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,108
63323-221-33Vancomycin Hydrochloride10 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,106
63323-221-38Vancomycin Hydrochloride25 in 1 TRAYINJECTION, POWDER, LYOPHILIZED,256
63323-221-43Vancomycin Hydrochloride10 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,105
63323-221-48Vancomycin Hydrochloride25 in 1 TRAYINJECTION, POWDER, LYOPHILIZED,255

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-221-01EA - Each63323-22115969898-e93b-4adf-8dce-2f06d66c226712021-09-07
63323-221-10EA - Each63323-2210ddcdf0d-7ce9-49ba-9418-6dd5b46c8eb412013-02-13
63323-221-16EA - Each63323-2218c581df8-0ea4-42c0-abec-614b243f00b112015-09-10
63323-221-33EA - Each63323-2216979b73c-eafe-4cce-b6d7-381e73c08a6512018-02-20
63323-221-38EA - Each63323-221d8cf2b75-d900-48f6-ab15-c20587c122cd12018-02-20
63323-221-41EA - Each63323-221003fe177-fdac-4efe-939b-a406d24ab7ba12021-09-07
63323-221-43EA - Each63323-221bfa5d38c-802d-484a-8a56-1ce5a80a90a412018-02-20
63323-221-48EA - Each63323-221d2db232f-1e3e-4f6f-bc35-4a40e4fa266212018-02-20

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
VANCOMYCIN HYDROCHLORIDEACTIVE INGREDIENT71WO621TJDVANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]1
VANCOMYCINACTIVE MOIETY6Q205EH1VUVANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-221VANCOMYCIN 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
63323-221VANCOMYCIN HYDROCHLORIDE (VANCOMYCIN HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC ]8Current NDC, Legacy NDC, 2 package rows20240404_0576803d-95de-4a48-806a-69ae3fcaf6b0.zip
63323-221VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI, LLC]6Current NDC, Legacy NDC, 2 package rows20221209_8a35ebee-8650-4ef5-84f5-ab9b55d9bc19.zip
63323-221VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI, LLC]5Current NDC, Legacy NDC, 2 package rows20221209_418c3c6a-d08d-448c-89c9-54e558c1ce16.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1807513vancomycin 1 GM InjectionPSNf604d399-fded-4f4f-8efe-af558ed07b9d17
1807516vancomycin 500 MG InjectionPSNf604d399-fded-4f4f-8efe-af558ed07b9d17
1807518vancomycin 750 MG InjectionPSNf604d399-fded-4f4f-8efe-af558ed07b9d17
1807513vancomycin 1000 MG InjectionSCDf604d399-fded-4f4f-8efe-af558ed07b9d17
1807516vancomycin 500 MG InjectionSCDf604d399-fded-4f4f-8efe-af558ed07b9d17
1807518vancomycin 750 MG InjectionSCDf604d399-fded-4f4f-8efe-af558ed07b9d17
1807513vancomycin (as vancomycin HCl) 1 GM InjectionSYf604d399-fded-4f4f-8efe-af558ed07b9d17
1807516vancomycin (as vancomycin HCl) 500 MG InjectionSYf604d399-fded-4f4f-8efe-af558ed07b9d17
1807513vancomycin 1 GM InjectionSYf604d399-fded-4f4f-8efe-af558ed07b9d17
1807518vancomycin 750 MG (as vancomycin hydrochloride 769 MG) InjectionSYf604d399-fded-4f4f-8efe-af558ed07b9d17
1807513vancomycin 1 GM InjectionPSN0576803d-95de-4a48-806a-69ae3fcaf6b08
1807516vancomycin 500 MG InjectionPSN0576803d-95de-4a48-806a-69ae3fcaf6b08
1807513vancomycin 1000 MG InjectionSCD0576803d-95de-4a48-806a-69ae3fcaf6b08
1807516vancomycin 500 MG InjectionSCD0576803d-95de-4a48-806a-69ae3fcaf6b08
1807513vancomycin (as vancomycin HCl) 1 GM InjectionSY0576803d-95de-4a48-806a-69ae3fcaf6b08
1807516vancomycin (as vancomycin HCl) 500 MG InjectionSY0576803d-95de-4a48-806a-69ae3fcaf6b08
1807513vancomycin 1 GM InjectionSY0576803d-95de-4a48-806a-69ae3fcaf6b08
1807516vancomycin 500 MG InjectionPSN8a35ebee-8650-4ef5-84f5-ab9b55d9bc196
1807516vancomycin 500 MG InjectionSCD8a35ebee-8650-4ef5-84f5-ab9b55d9bc196
1807516vancomycin (as vancomycin HCl) 500 MG InjectionSY8a35ebee-8650-4ef5-84f5-ab9b55d9bc196
1807513vancomycin 1 GM InjectionPSN418c3c6a-d08d-448c-89c9-54e558c1ce165
1807516vancomycin 500 MG InjectionPSN418c3c6a-d08d-448c-89c9-54e558c1ce165
1807513vancomycin 1000 MG InjectionSCD418c3c6a-d08d-448c-89c9-54e558c1ce165
1807516vancomycin 500 MG InjectionSCD418c3c6a-d08d-448c-89c9-54e558c1ce165
1807513vancomycin (as vancomycin HCl) 1 GM InjectionSY418c3c6a-d08d-448c-89c9-54e558c1ce165
1807516vancomycin (as vancomycin HCl) 500 MG InjectionSY418c3c6a-d08d-448c-89c9-54e558c1ce165
1807513vancomycin 1 GM InjectionSY418c3c6a-d08d-448c-89c9-54e558c1ce165

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-221-016332302210110 mL in 1 VIAL10 mlHistorical
63323-221-106332302211025 VIAL in 1 TRAY (63323-221-10) / 10 mL in 1 VIAL (63323-221-01) 25 vial2000-09-010000-00-00NoNoCurrent
63323-221-166332302211625 VIAL in 1 TRAY (63323-221-16) / 10 mL in 1 VIAL (63323-221-41) 25 vial2021-05-030000-00-00NoNoCurrent
63323-221-336332302213310 mL in 1 VIAL10 mlHistorical
63323-221-386332302213825 VIAL in 1 TRAY (63323-221-38) / 10 mL in 1 VIAL (63323-221-33) 25 vial2017-11-010000-00-00NoNoCurrent
63323-221-416332302214110 mL in 1 VIAL10 mlHistorical
63323-221-436332302214310 mL in 1 VIAL10 mlHistorical
63323-221-486332302214825 VIAL in 1 TRAY (63323-221-48) / 10 mL in 1 VIAL (63323-221-43) 25 vial2017-10-260000-00-00NoNoCurrent