Vancomycin Hydrochloride

Product NDC
70594-045
11-digit product format
705940045
Labeler code
70594
Product ID
70594-045_d0999ed3-4357-4df9-998a-6b6a0e9bba52
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
vancomycin hydrochloride
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Xellia Pharmaceuticals USA LLC
Application
ANDA204107
Marketing category
ANDA
Marketing start
2019-01-28
Marketing end
0000-00-00
Substance
VANCOMYCIN HYDROCHLORIDE
Active strength
500 mg/1
Pharmacologic classes
Glycopeptide Antibacterial [EPC], Glycopeptides [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70594-045-032025-07-29C16284748780-13b156c62-2ab9-fb37-e063-e6dba90a4e07Vancomycin Hydrochloride for Injection, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70594-045-01Vancomycin Hydrochloride1 in 1 VIAL, GLASSINJECTION, POWDER, FOR SOLUTION18
70594-045-02Vancomycin Hydrochloride10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION108
70594-045-03Vancomycin Hydrochloride25 in 1 CARTONINJECTION, POWDER, FOR SOLUTION258

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70594-045-01EA - Each70594-045eb897f55-11d8-452b-93b5-2908f8491aa612022-03-09
70594-045-02EA - Each70594-04554b7ab77-ef4c-4236-bcb3-7c117169715c12022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70594-045VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, FOR SOLUTION [XELLIA PHARMACEUTICALS USA LLC]8Legacy NDC, 3 package rows20221011_7e416822-15cf-4749-9599-2c9710e1674c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1807513vancomycin 1 GM InjectionPSN7e416822-15cf-4749-9599-2c9710e1674c8
1807516vancomycin 500 MG InjectionPSN7e416822-15cf-4749-9599-2c9710e1674c8
1807513vancomycin 1000 MG InjectionSCD7e416822-15cf-4749-9599-2c9710e1674c8
1807516vancomycin 500 MG InjectionSCD7e416822-15cf-4749-9599-2c9710e1674c8
1807513vancomycin (as vancomycin HCl) 1 GM InjectionSY7e416822-15cf-4749-9599-2c9710e1674c8
1807516vancomycin (as vancomycin HCl) 500 MG InjectionSY7e416822-15cf-4749-9599-2c9710e1674c8
1807513vancomycin 1 GM InjectionSY7e416822-15cf-4749-9599-2c9710e1674c8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70594-045-01705940045011 in 1 VIAL, GLASSHistorical
70594-045-027059400450210 VIAL, GLASS in 1 CARTON (70594-045-02) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (70594-045-01) 2019-01-280000-00-00NoNoCurrent
70594-045-037059400450325 CARTON in 1 CARTON (70594-045-03) > 10 VIAL, GLASS in 1 CARTON (70594-045-02) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (70594-045-01) 25 carton2019-01-280000-00-00NoNoCurrent