FDA.reportPublic FDA data

Vancomycin Hydrochloride

Product NDC
63323-314
11-digit product format
633230314
Labeler code
63323
Product ID
63323-314_020618ad-8f1f-4189-a95c-254f05a077cc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
VANCOMYCIN HYDROCHLORIDE
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA062663
Marketing category
ANDA
Marketing start
2004-11-30
Substance
VANCOMYCIN HYDROCHLORIDE
Active strength
10 g/100mL
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 HYDROCHLORIDE10 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii71WO621TJD
Rxcui239209, 313572

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
63323-314-61Vancomycin Hydrochloride100 mL in 1 BOTTLEINJECTION, POWDER, LYOPHILIZED,1007
63323-314-61Vancomycin Hydrochloride1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,17
63323-314-66Vancomycin Hydrochloride100 mL in 1 BOTTLEINJECTION, POWDER, LYOPHILIZED,1006
63323-314-66Vancomycin Hydrochloride1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,16
63323-314-68Vancomycin Hydrochloride1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,16
63323-314-68Vancomycin Hydrochloride100 mL in 1 BOTTLEINJECTION, POWDER, LYOPHILIZED,1006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-314-61EA - Each63323-314c3608c1a-6105-49bc-9847-b94e42de64d612013-02-13
63323-314-66EA - Each63323-31447a7b0b2-8935-4937-888f-f96369b8220812015-09-10
63323-314-68EA - Each63323-314e69eee50-bbca-4c0d-8e06-e60a53ae301c12017-11-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VANCOMYCIN HYDROCHLORIDEACTIVE INGREDIENT71WO621TJDVANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]1
VANCOMYCIN HYDROCHLORIDEACTIVE INGREDIENT71WO621TJDVANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [APP PHARMACEUTICALS, LLC]1
VANCOMYCINACTIVE MOIETY6Q205EH1VUVANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]1
VANCOMYCINACTIVE MOIETY6Q205EH1VUVANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [APP PHARMACEUTICALS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-314VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC ]7Current NDC, Legacy NDC, 2 package rows20211007_d3147f2d-1a72-4923-874b-8fdee2be625e.zip
63323-314VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC ]6Current NDC, Legacy NDC, 2 package rows20230316_0713a847-a334-4b73-af22-343aa06621b9.zip
63323-314VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI, LLC]6Current NDC, Legacy NDC, 2 package rows20190209_a7e7d990-1d74-459b-ac07-d1c3e13b3204.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
239209vancomycin 100 MG/ML Injectable SolutionPSNd3147f2d-1a72-4923-874b-8fdee2be625e7
313572vancomycin 50 MG/ML Injectable SolutionPSNd3147f2d-1a72-4923-874b-8fdee2be625e7
239209vancomycin 100 MG/ML Injectable SolutionSCDd3147f2d-1a72-4923-874b-8fdee2be625e7
313572vancomycin 50 MG/ML Injectable SolutionSCDd3147f2d-1a72-4923-874b-8fdee2be625e7
239209vancomycin (as vancomycin hydrochloride) 100 MG/ML Injectable SolutionSYd3147f2d-1a72-4923-874b-8fdee2be625e7
313572vancomycin (as vancomycin hydrochloride) 50 MG/ML Injectable SolutionSYd3147f2d-1a72-4923-874b-8fdee2be625e7
239209vancomycin 100 MG/ML Injectable SolutionPSN0713a847-a334-4b73-af22-343aa06621b96
239209vancomycin 100 MG/ML Injectable SolutionPSNa7e7d990-1d74-459b-ac07-d1c3e13b32046
313572vancomycin 50 MG/ML Injectable SolutionPSN0713a847-a334-4b73-af22-343aa06621b96
239209vancomycin 100 MG/ML Injectable SolutionSCD0713a847-a334-4b73-af22-343aa06621b96
239209vancomycin 100 MG/ML Injectable SolutionSCDa7e7d990-1d74-459b-ac07-d1c3e13b32046
313572vancomycin 50 MG/ML Injectable SolutionSCD0713a847-a334-4b73-af22-343aa06621b96
239209vancomycin (as vancomycin hydrochloride) 100 MG/ML Injectable SolutionSY0713a847-a334-4b73-af22-343aa06621b96
239209vancomycin (as vancomycin hydrochloride) 100 MG/ML Injectable SolutionSYa7e7d990-1d74-459b-ac07-d1c3e13b32046
313572vancomycin (as vancomycin hydrochloride) 50 MG/ML Injectable SolutionSY0713a847-a334-4b73-af22-343aa06621b96

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-314-61633230314611 BOTTLE in 1 CARTON (63323-314-61) / 100 mL in 1 BOTTLE1 bottle2004-11-300000-00-00NoNoCurrent
63323-314-66633230314661 BOTTLE in 1 CARTON (63323-314-66) / 100 mL in 1 BOTTLE1 bottle2004-11-300000-00-00NoNoCurrent
63323-314-68633230314681 BOTTLE in 1 CARTON (63323-314-68) / 100 mL in 1 BOTTLE1 bottle2017-09-010000-00-00NoNoCurrent