FDA.reportPublic FDA data

Vancomycin Hydrochloride

Product NDC
0409-6509
11-digit product format
004096509
Labeler code
0409
Product ID
0409-6509_39396834-5ba8-43a0-8ba2-719755e332b9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
VANCOMYCIN HYDROCHLORIDE
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Hospira, Inc.
Application
ANDA063076
Marketing category
ANDA
Marketing start
2005-06-06
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
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
0409-6509-01Vancomycin Hydrochloride1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,129
0409-6509-01Vancomycin Hydrochloride100 mL in 1 VIAL, PHARMACY BULK PACKAGEINJECTION, POWDER, LYOPHILIZED,10029
0409-6509-49Vancomycin Hydrochloride1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,118
0409-6509-49Vancomycin Hydrochloride100 mL in 1 VIAL, PHARMACY BULK PACKAGEINJECTION, POWDER, LYOPHILIZED,10018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-6509-01EA - Each0409-6509f7d634bc-4fc8-4134-8ea6-75c7f916c51c12012-07-24
0409-6509-49EA - Each0409-650996843d1b-35c7-4cee-9df3-a3b7e5d4ee3212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VANCOMYCIN HYDROCHLORIDEACTIVE INGREDIENT71WO621TJDVANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.]17
VANCOMYCINACTIVE MOIETY6Q205EH1VUVANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.]17
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBVANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.]17
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IVANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.]17
VANCOMYCIN HYDROCHLORIDEACTIVE INGREDIENT71WO621TJDVANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.]1
VANCOMYCINACTIVE MOIETY6Q205EH1VUVANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBVANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IVANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-6509VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.]29Current NDC, Legacy NDC, 2 package rows20250119_91c050cf-3b2d-48bc-7297-e8dc68225e5a.zip
0409-6509VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.]18Current NDC, Legacy NDC, 2 package rows20250117_b01aaa02-8f1d-4b57-96a5-337503428af1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
239209vancomycin 100 MG/ML Injectable SolutionPSN91c050cf-3b2d-48bc-7297-e8dc68225e5a29
313572vancomycin 50 MG/ML Injectable SolutionPSN91c050cf-3b2d-48bc-7297-e8dc68225e5a29
239209vancomycin 100 MG/ML Injectable SolutionSCD91c050cf-3b2d-48bc-7297-e8dc68225e5a29
313572vancomycin 50 MG/ML Injectable SolutionSCD91c050cf-3b2d-48bc-7297-e8dc68225e5a29
239209vancomycin (as vancomycin hydrochloride) 100 MG/ML Injectable SolutionSY91c050cf-3b2d-48bc-7297-e8dc68225e5a29
313572vancomycin (as vancomycin hydrochloride) 50 MG/ML Injectable SolutionSY91c050cf-3b2d-48bc-7297-e8dc68225e5a29
239209vancomycin 100 MG/ML Injectable SolutionPSNb01aaa02-8f1d-4b57-96a5-337503428af118
313572vancomycin 50 MG/ML Injectable SolutionPSNb01aaa02-8f1d-4b57-96a5-337503428af118
239209vancomycin 100 MG/ML Injectable SolutionSCDb01aaa02-8f1d-4b57-96a5-337503428af118
313572vancomycin 50 MG/ML Injectable SolutionSCDb01aaa02-8f1d-4b57-96a5-337503428af118
239209vancomycin (as vancomycin hydrochloride) 100 MG/ML Injectable SolutionSYb01aaa02-8f1d-4b57-96a5-337503428af118
313572vancomycin (as vancomycin hydrochloride) 50 MG/ML Injectable SolutionSYb01aaa02-8f1d-4b57-96a5-337503428af118

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0409-6509-01004096509011 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (0409-6509-01) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE2005-06-060000-00-00NoNoCurrent
0409-6509-49004096509491 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (0409-6509-49) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE2019-01-150000-00-00NoNoCurrent