FDA.reportPublic FDA data

Vancomycin Hydrochloride

Product NDC
70594-122
11-digit product format
705940122
Labeler code
70594
Product ID
70594-122_047a47f7-3fc4-4f77-aae1-a895c0f47e32
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
vancomycin hydrochloride
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Xellia Pharmaceuticals USA LLC
Application
ANDA205694
Marketing category
ANDA
Marketing start
2016-02-23
Substance
VANCOMYCIN HYDROCHLORIDE
Active strength
500 mg/1
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/1

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
70594-122-01Vancomycin Hydrochloride1 in 1 VIAL, GLASSINJECTION, POWDER, LYOPHILIZED,11
70594-122-02Vancomycin Hydrochloride10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70594-122-01EA - Each70594-1222dd58a64-931a-406e-8f20-2134ed49aeaf12024-03-12
70594-122-02EA - Each70594-12264158d41-52ae-40e7-b7c0-8ebe89b9a05212024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70594-122VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [XELLIA PHARMACEUTICALS USA LLC]1Current NDC, 2 package rows20231214_8403695c-3614-490b-9797-6c5ebcdeef9b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1807513vancomycin 1 GM InjectionPSN8403695c-3614-490b-9797-6c5ebcdeef9b1
1807516vancomycin 500 MG InjectionPSN8403695c-3614-490b-9797-6c5ebcdeef9b1
1807513vancomycin 1000 MG InjectionSCD8403695c-3614-490b-9797-6c5ebcdeef9b1
1807516vancomycin 500 MG InjectionSCD8403695c-3614-490b-9797-6c5ebcdeef9b1
1807513vancomycin (as vancomycin HCl) 1 GM InjectionSY8403695c-3614-490b-9797-6c5ebcdeef9b1
1807516vancomycin (as vancomycin HCl) 500 MG InjectionSY8403695c-3614-490b-9797-6c5ebcdeef9b1
1807513vancomycin 1 GM InjectionSY8403695c-3614-490b-9797-6c5ebcdeef9b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70594-122-01705940122011 in 1 VIAL, GLASSHistorical
70594-122-027059401220210 VIAL, GLASS in 1 CARTON (70594-122-02) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS (70594-122-01) 2023-10-29NoNoHistorical