Vancomycin Hydrochloride

Product NDC
67457-705
11-digit product format
674570705
Labeler code
67457
Product ID
67457-705_a0a9dc82-4ffe-4798-8ec4-f4021bf6fc9f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Vancomycin Hydrochloride
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Mylan Institutional LLC
Application
NDA209481
Marketing category
NDA
Marketing start
2018-08-31
Substance
VANCOMYCIN HYDROCHLORIDE
Active strength
750 mg/15mL
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 HYDROCHLORIDE750 mg/15mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii71WO621TJD
Rxcui1807518, 2049888, 2049890, 2049891

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
67457-705-00Vancomycin Hydrochloride15 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,1512
67457-705-75Vancomycin Hydrochloride10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,1012

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67457-705VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MYLAN INSTITUTIONAL LLC]12Current NDC, Legacy NDC, 2 package rows20240731_caf22ccb-df75-45ea-a1d0-ccb2d37272fb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2049888vancomycin 1.25 GM InjectionPSNcaf22ccb-df75-45ea-a1d0-ccb2d37272fb12
2049890vancomycin 1.5 GM InjectionPSNcaf22ccb-df75-45ea-a1d0-ccb2d37272fb12
2049891vancomycin 250 MG InjectionPSNcaf22ccb-df75-45ea-a1d0-ccb2d37272fb12
1807518vancomycin 750 MG InjectionPSNcaf22ccb-df75-45ea-a1d0-ccb2d37272fb12
2049888vancomycin 1250 MG InjectionSCDcaf22ccb-df75-45ea-a1d0-ccb2d37272fb12
2049890vancomycin 1500 MG InjectionSCDcaf22ccb-df75-45ea-a1d0-ccb2d37272fb12
2049891vancomycin 250 MG InjectionSCDcaf22ccb-df75-45ea-a1d0-ccb2d37272fb12
1807518vancomycin 750 MG InjectionSCDcaf22ccb-df75-45ea-a1d0-ccb2d37272fb12
2049891vancomycin (as vancomycin hydrochloride) 250 MG InjectionSYcaf22ccb-df75-45ea-a1d0-ccb2d37272fb12
2049888vancomycin 1.25 GM (as vancomycin hydrochloride 1.28 GM) InjectionSYcaf22ccb-df75-45ea-a1d0-ccb2d37272fb12
2049888vancomycin 1.25 GM InjectionSYcaf22ccb-df75-45ea-a1d0-ccb2d37272fb12
2049890vancomycin 1.5 GM (as vancomycin hydrochloride 1.54 GM) InjectionSYcaf22ccb-df75-45ea-a1d0-ccb2d37272fb12
2049890vancomycin 1.5 GM InjectionSYcaf22ccb-df75-45ea-a1d0-ccb2d37272fb12
1807518vancomycin 750 MG (as vancomycin hydrochloride 769 MG) InjectionSYcaf22ccb-df75-45ea-a1d0-ccb2d37272fb12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67457-705-006745707050015 mL in 1 VIAL, SINGLE-DOSE15 mlHistorical
67457-705-756745707057510 VIAL, SINGLE-DOSE in 1 CARTON (67457-705-75) / 15 mL in 1 VIAL, SINGLE-DOSE (67457-705-00) 2018-08-310000-00-00NoNoCurrent