FDA.reportPublic FDA data

VANCOMYCIN HYDROCHLORIDE

Product NDC
0338-3582
11-digit product format
003383582
Labeler code
0338
Product ID
0338-3582_4e548f07-0e95-4ae7-bda2-176cb4a781fd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
VANCOMYCIN HYDROCHLORIDE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Baxter Healthcare Corporation
Application
NDA050671
Marketing category
NDA
Marketing start
1958-11-14
Substance
VANCOMYCIN HYDROCHLORIDE
Active strength
750 mg/150mL
Pharmacologic classes
Glycopeptide Antibacterial [EPC], Glycopeptides [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
VANCOMYCIN HYDROCHLORIDE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VANCOMYCIN HYDROCHLORIDE750 mg/150mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii71WO621TJD
Rxcui1807508, 1807510, 1807511, 2118448, 2387078

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
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
e5c5573a-2fda-453b-9d65-c6185b588ecdProduct name520220613
3a86dfd0-ed28-4976-b9ec-00923fbfbdd4Product name120220308
5d603187-d384-6e74-5fc7-30310b2b3c99Product name320190717
bec007f0-8cd6-4f79-a3df-c0d94ebb2a36Product name120190614
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
f4fec0bc-aaaa-4c5c-aa2b-21daf18ef477Product name120160209
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
a0c54c75-e1f1-eb4f-25c4-be91c2fe237dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0338-3582-01VANCOMYCIN HYDROCHLORIDE150 mL in 1 BAGINJECTION, SOLUTION15026

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0338-3582VANCOMYCIN HYDROCHLORIDE INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]24Current NDC, Legacy NDC, 1 package rows20240622_99e523d8-9bde-43cb-8434-497015e5dcbd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1807508vancomycin 1 GM in 200 ML InjectionPSN99e523d8-9bde-43cb-8434-497015e5dcbd26
2387078vancomycin 1.25 GM in 250 ML InjectionPSN99e523d8-9bde-43cb-8434-497015e5dcbd26
2118448vancomycin 1.5 GM in 300 ML InjectionPSN99e523d8-9bde-43cb-8434-497015e5dcbd26
1807511vancomycin 500 MG in 100 ML InjectionPSN99e523d8-9bde-43cb-8434-497015e5dcbd26
1807510vancomycin 750 MG in 150 ML InjectionPSN99e523d8-9bde-43cb-8434-497015e5dcbd26
1807511100 ML vancomycin 5 MG/ML InjectionSCD99e523d8-9bde-43cb-8434-497015e5dcbd26
1807510150 ML vancomycin 5 MG/ML InjectionSCD99e523d8-9bde-43cb-8434-497015e5dcbd26
1807508200 ML vancomycin 5 MG/ML InjectionSCD99e523d8-9bde-43cb-8434-497015e5dcbd26
2387078250 ML vancomycin 5 MG/ML InjectionSCD99e523d8-9bde-43cb-8434-497015e5dcbd26
2118448300 ML vancomycin 5 MG/ML InjectionSCD99e523d8-9bde-43cb-8434-497015e5dcbd26
2118448vancomycin (as vancomycin HCl) 1.5 GM per 300 ML InjectionSY99e523d8-9bde-43cb-8434-497015e5dcbd26
1807511vancomycin (as vancomycin HCl) 500 MG per 100 ML InjectionSY99e523d8-9bde-43cb-8434-497015e5dcbd26
1807508vancomycin (as vancomycin hydrochloride) 1 GM per 200 ML InjectionSY99e523d8-9bde-43cb-8434-497015e5dcbd26
1807510vancomycin (as vancomycin hydrochloride) 750 MG per 150 ML InjectionSY99e523d8-9bde-43cb-8434-497015e5dcbd26
1807508vancomycin 1 GM per 200 ML InjectionSY99e523d8-9bde-43cb-8434-497015e5dcbd26
2387078vancomycin 1.25 GM per 250 ML InjectionSY99e523d8-9bde-43cb-8434-497015e5dcbd26
2118448vancomycin 1.5 GM per 300 ML InjectionSY99e523d8-9bde-43cb-8434-497015e5dcbd26
2387078vancomycin 1250 MG per 250 ML InjectionSY99e523d8-9bde-43cb-8434-497015e5dcbd26
1807511vancomycin 500 MG per 100 ML InjectionSY99e523d8-9bde-43cb-8434-497015e5dcbd26
1807510vancomycin 750 MG per 150 ML InjectionSY99e523d8-9bde-43cb-8434-497015e5dcbd26

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0338-3582-0100338358201150 mL in 1 BAG (0338-3582-01) 150 ml2015-12-180000-00-00NoNoCurrent