FDA.reportPublic FDA data

VANCOMYCIN HYDROCHLORIDE

Product NDC
0143-9163
11-digit product format
001439163
Labeler code
0143
Product ID
0143-9163_0e6d2908-b33a-4f3e-a283-e8e1a2d38e5f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
vancomycin hydrochloride
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS; ORAL
Labeler
HIKMA PHARMACEUTICALS USA INC.
Application
NDA210274
Marketing category
NDA
Marketing start
2023-02-03
Substance
VANCOMYCIN HYDROCHLORIDE
Active strength
5.13 g/g
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 HYDROCHLORIDE5.13 g/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii71WO621TJD
Rxcui239209

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
0143-9163-01VANCOMYCIN HYDROCHLORIDE5.13 g in 1 VIAL, PHARMACY BULK PACKAGEINJECTION, POWDER, FOR SOLUTION5.134
0143-9163-01VANCOMYCIN HYDROCHLORIDE1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9163-01EA - Each0143-916367c68a14-a676-4bc2-abf2-114689f5b24412023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9163VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.]4Current NDC, 2 package rows20240810_e4ce7b87-fab4-4b7a-b121-eba136c464ce.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
239209vancomycin 100 MG/ML Injectable SolutionPSNe4ce7b87-fab4-4b7a-b121-eba136c464ce4
239209vancomycin 100 MG/ML Injectable SolutionSCDe4ce7b87-fab4-4b7a-b121-eba136c464ce4
239209vancomycin (as vancomycin hydrochloride) 100 MG/ML Injectable SolutionSYe4ce7b87-fab4-4b7a-b121-eba136c464ce4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0143-9163-01001439163011 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (0143-9163-01) / 5.13 g in 1 VIAL, PHARMACY BULK PACKAGE2023-02-03NoNoHistorical