Vancomycin Hydrochloride

Product NDC
72078-066
11-digit product format
720780066
Labeler code
72078
Product ID
72078-066_40a88420-5fcb-4715-abc5-595a18fd08d0
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
2024-07-23
Substance
VANCOMYCIN HYDROCHLORIDE
Active strength
2 g/40mL
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 HYDROCHLORIDE2 g/40mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii71WO621TJD
Rxcui2688632, 2688634

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
72078-066-50Vancomycin Hydrochloride1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,11
72078-066-50Vancomycin Hydrochloride50 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,501
72078-066-99Vancomycin Hydrochloride10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,101
72078-066-99Vancomycin Hydrochloride50 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,501

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72078-066-50EA - Each72078-06665af1c9a-1e4e-4026-bcac-c9bc2f39571512024-08-12
72078-066-99EA - Each72078-0665f6b6ddc-245d-46ca-9a26-b92e82f1925b12024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72078-066VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MYLAN INSTITUTIONAL LLC]1Current NDC, 4 package rows20240725_40a88420-5fcb-4715-abc5-595a18fd08d0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2688632vancomycin 1.75 GM InjectionPSN40a88420-5fcb-4715-abc5-595a18fd08d01
2688634vancomycin 2 GM InjectionPSN40a88420-5fcb-4715-abc5-595a18fd08d01
2688632vancomycin 1750 MG InjectionSCD40a88420-5fcb-4715-abc5-595a18fd08d01
2688634vancomycin 2000 MG InjectionSCD40a88420-5fcb-4715-abc5-595a18fd08d01
2688632vancomycin (as vancomycin hydrochloride) 1.75 GM InjectionSY40a88420-5fcb-4715-abc5-595a18fd08d01
2688634vancomycin (as vancomycin hydrochloride) 2 GM InjectionSY40a88420-5fcb-4715-abc5-595a18fd08d01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72078-066-50720780066501 in 1 CARTONHistorical
72078-066-997207800669910 VIAL, SINGLE-DOSE in 1 CARTON (72078-066-99) / 50 mL in 1 VIAL, SINGLE-DOSE2024-07-23NoNoCurrent