FDA.reportPublic FDA data

Vancomycin

Product NDC
70594-043
11-digit product format
705940043
Labeler code
70594
Product ID
70594-043_e49b6589-caca-4c8f-8c57-55a1ee7774cc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Vancomycin
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Xellia Pharmaceuticals USA LLC
Application
NDA211962
Marketing category
NDA
Marketing start
2019-02-15
Substance
VANCOMYCIN
Active strength
1.5 g/300mL
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VANCOMYCIN1.5 g/300mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6Q205EH1VU
Rxcui1807508, 1807510, 1807511, 2118448, 2118449, 2387078, 2387079

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
70594-043-01Vancomycin300 mL in 1 BAGINJECTION, SOLUTION30017
70594-043-02Vancomycin6 in 1 CARTONINJECTION, SOLUTION617

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70594-043-01ML - Milliliter70594-043d7addbc0-a6a1-4aa0-b3fe-009b08aa633612019-04-11
70594-043-02ML - Milliliter70594-0434bf3d578-3b1b-4910-bd09-6819622af03912019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70594-043VANCOMYCIN INJECTION, SOLUTION [XELLIA PHARMACEUTICALS USA LLC]17Current NDC, Legacy NDC, 2 package rows20230331_60bee69b-be70-412c-9e83-a24a0a8a5e7b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1807508vancomycin 1 GM in 200 ML InjectionPSN60bee69b-be70-412c-9e83-a24a0a8a5e7b17
2387078vancomycin 1.25 GM in 250 ML InjectionPSN60bee69b-be70-412c-9e83-a24a0a8a5e7b17
2118448vancomycin 1.5 GM in 300 ML InjectionPSN60bee69b-be70-412c-9e83-a24a0a8a5e7b17
2387079vancomycin 1.75 GM in 350 ML InjectionPSN60bee69b-be70-412c-9e83-a24a0a8a5e7b17
2118449vancomycin 2 GM in 400 ML InjectionPSN60bee69b-be70-412c-9e83-a24a0a8a5e7b17
1807511vancomycin 500 MG in 100 ML InjectionPSN60bee69b-be70-412c-9e83-a24a0a8a5e7b17
1807510vancomycin 750 MG in 150 ML InjectionPSN60bee69b-be70-412c-9e83-a24a0a8a5e7b17
1807511100 ML vancomycin 5 MG/ML InjectionSCD60bee69b-be70-412c-9e83-a24a0a8a5e7b17
1807510150 ML vancomycin 5 MG/ML InjectionSCD60bee69b-be70-412c-9e83-a24a0a8a5e7b17
1807508200 ML vancomycin 5 MG/ML InjectionSCD60bee69b-be70-412c-9e83-a24a0a8a5e7b17
2387078250 ML vancomycin 5 MG/ML InjectionSCD60bee69b-be70-412c-9e83-a24a0a8a5e7b17
2118448300 ML vancomycin 5 MG/ML InjectionSCD60bee69b-be70-412c-9e83-a24a0a8a5e7b17
2387079350 ML vancomycin 5 MG/ML InjectionSCD60bee69b-be70-412c-9e83-a24a0a8a5e7b17
2118449400 ML vancomycin 5 MG/ML InjectionSCD60bee69b-be70-412c-9e83-a24a0a8a5e7b17
2118448vancomycin (as vancomycin HCl) 1.5 GM per 300 ML InjectionSY60bee69b-be70-412c-9e83-a24a0a8a5e7b17
2118449vancomycin (as vancomycin HCl) 2 GM per 400 ML InjectionSY60bee69b-be70-412c-9e83-a24a0a8a5e7b17
1807511vancomycin (as vancomycin HCl) 500 MG per 100 ML InjectionSY60bee69b-be70-412c-9e83-a24a0a8a5e7b17
1807508vancomycin (as vancomycin hydrochloride) 1 GM per 200 ML InjectionSY60bee69b-be70-412c-9e83-a24a0a8a5e7b17
1807510vancomycin (as vancomycin hydrochloride) 750 MG per 150 ML InjectionSY60bee69b-be70-412c-9e83-a24a0a8a5e7b17
1807508vancomycin 1 GM per 200 ML InjectionSY60bee69b-be70-412c-9e83-a24a0a8a5e7b17
2387078vancomycin 1.25 GM per 250 ML InjectionSY60bee69b-be70-412c-9e83-a24a0a8a5e7b17
2118448vancomycin 1.5 GM per 300 ML InjectionSY60bee69b-be70-412c-9e83-a24a0a8a5e7b17
2387079vancomycin 1.75 GM per 350 ML InjectionSY60bee69b-be70-412c-9e83-a24a0a8a5e7b17
2387078vancomycin 1250 MG per 250 ML InjectionSY60bee69b-be70-412c-9e83-a24a0a8a5e7b17
2387079vancomycin 1750 MG per 350 ML InjectionSY60bee69b-be70-412c-9e83-a24a0a8a5e7b17
2118449vancomycin 2 GM per 400 ML InjectionSY60bee69b-be70-412c-9e83-a24a0a8a5e7b17
1807511vancomycin 500 MG per 100 ML InjectionSY60bee69b-be70-412c-9e83-a24a0a8a5e7b17
1807510vancomycin 750 MG per 150 ML InjectionSY60bee69b-be70-412c-9e83-a24a0a8a5e7b17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70594-043-0170594004301300 mL in 1 BAG300 mlHistorical
70594-043-02705940043026 BAG in 1 CARTON (70594-043-02) / 300 mL in 1 BAG (70594-043-01) 6 bag2019-02-150000-00-00NoNoCurrent