FDA.reportPublic FDA data

Vancomycin Hydrochloride

Product NDC
63323-284
11-digit product format
633230284
Labeler code
63323
Product ID
63323-284_23a89459-d331-4975-84fe-4bfa6ed2c24e
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
2017-10-26
Substance
VANCOMYCIN HYDROCHLORIDE
Active strength
1 g/20mL
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 HYDROCHLORIDE1 g/20mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii71WO621TJD
Rxcui1807513, 1807516

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
63323-284-01VANCOMYCIN HYDROCHLORIDE20 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,2017
63323-284-20VANCOMYCIN HYDROCHLORIDE10 in 1 TRAYINJECTION, POWDER, LYOPHILIZED,1017
63323-284-26VANCOMYCIN HYDROCHLORIDE10 in 1 TRAYINJECTION, POWDER, LYOPHILIZED,108
63323-284-42VANCOMYCIN HYDROCHLORIDE20 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,208
63323-284-41Vancomycin Hydrochloride20 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,205
63323-284-45Vancomycin Hydrochloride10 in 1 TRAYINJECTION, POWDER, LYOPHILIZED,105
63323-284-21VANCOMYCIN HYDROCHLORIDE10 in 1 TRAYINJECTION, POWDER, LYOPHILIZED,103
63323-284-21VANCOMYCIN HYDROCHLORIDE20 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,203

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-284-01EA - Each63323-2844f14b5a3-79c4-48b7-bdf2-b9ce378d63df12021-07-15
63323-284-20EA - Each63323-284d35e820f-cbba-476d-9ea6-28b08a91991912013-02-13
63323-284-21EA - Each63323-284868b29d1-7274-437c-adbf-b05628fe92f812016-02-04
63323-284-26EA - Each63323-2846688da60-5b9e-42a8-82e1-794deca75a6912015-09-10
63323-284-41EA - Each63323-2849ca01873-7d4f-4799-8623-83f2ae99d4e012018-02-20
63323-284-42EA - Each63323-284dd09a04e-3c86-47d9-905a-8e7268e8f77612021-11-09
63323-284-45EA - Each63323-284a59758c0-c0c7-4af4-9b4e-7245d83a2c9112018-02-20

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
63323-284VANCOMYCIN 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
63323-284VANCOMYCIN 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
63323-284VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI, LLC]5Current NDC, Legacy NDC, 2 package rows20221209_418c3c6a-d08d-448c-89c9-54e558c1ce16.zip
63323-284VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]3Current NDC, Legacy NDC, 2 package rows20241019_83ea3faf-fedd-4725-911f-d71a23ec5d5e.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
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
1807513vancomycin 1 GM InjectionPSN83ea3faf-fedd-4725-911f-d71a23ec5d5e3
1807513vancomycin 1000 MG InjectionSCD83ea3faf-fedd-4725-911f-d71a23ec5d5e3
1807513vancomycin (as vancomycin HCl) 1 GM InjectionSY83ea3faf-fedd-4725-911f-d71a23ec5d5e3
1807513vancomycin 1 GM InjectionSY83ea3faf-fedd-4725-911f-d71a23ec5d5e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-284-016332302840120 mL in 1 VIAL20 mlHistorical
63323-284-206332302842010 VIAL in 1 TRAY (63323-284-20) / 20 mL in 1 VIAL (63323-284-01) 10 vial2000-09-200000-00-00NoNoCurrent
63323-284-216332302842110 VIAL in 1 TRAY (63323-284-21) / 20 mL in 1 VIAL10 vial2000-09-200000-00-00NoNoCurrent
63323-284-266332302842610 VIAL in 1 TRAY (63323-284-26) / 20 mL in 1 VIAL (63323-284-42) 10 vial2021-05-030000-00-00NoNoCurrent
63323-284-416332302844120 mL in 1 VIAL20 mlHistorical
63323-284-426332302844220 mL in 1 VIAL20 mlHistorical
63323-284-456332302844510 VIAL in 1 TRAY (63323-284-45) / 20 mL in 1 VIAL (63323-284-41) 10 vial2017-10-260000-00-00NoNoCurrent