FDA.reportPublic FDA data

VANCOMYCIN HYDROCHLORIDE

Product NDC
0143-9161
11-digit product format
001439161
Labeler code
0143
Product ID
0143-9161_d17179c5-783a-487a-ab74-fb8ad3eb9c34
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
2023-02-02
Substance
VANCOMYCIN HYDROCHLORIDE
Active strength
513 mg/mg
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 HYDROCHLORIDE513 mg/mg

Harmonized Identifiers#

Field, Values table
FieldValues
Unii71WO621TJD
Rxcui1807513, 1807516, 1807518, 2049888, 2049890

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
0143-9161-01VANCOMYCIN HYDROCHLORIDE513 mg in 1 VIALINJECTION, POWDER, FOR SOLUTION5135
0143-9161-10VANCOMYCIN HYDROCHLORIDE10 in 1 PACKAGEINJECTION, POWDER, FOR SOLUTION105
0143-9161-25VANCOMYCIN HYDROCHLORIDE25 in 1 PACKAGEINJECTION, POWDER, FOR SOLUTION255

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9161-01EA - Each0143-916189f7647c-cb84-47b2-8001-07aed674fce312023-09-05
0143-9161-10EA - Each0143-91610792087e-17b5-4ced-8120-f709815cb58112025-07-08
0143-9161-25EA - Each0143-9161d3274a26-512d-476e-8600-0e2397a938c312023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9161VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.]4Current NDC, 3 package rows20241206_8eccafe8-40c9-495a-872d-7f45a98ee759.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1807513vancomycin 1 GM InjectionPSN8eccafe8-40c9-495a-872d-7f45a98ee7595
2049888vancomycin 1.25 GM InjectionPSN8eccafe8-40c9-495a-872d-7f45a98ee7595
2049890vancomycin 1.5 GM InjectionPSN8eccafe8-40c9-495a-872d-7f45a98ee7595
1807516vancomycin 500 MG InjectionPSN8eccafe8-40c9-495a-872d-7f45a98ee7595
1807518vancomycin 750 MG InjectionPSN8eccafe8-40c9-495a-872d-7f45a98ee7595
1807513vancomycin 1000 MG InjectionSCD8eccafe8-40c9-495a-872d-7f45a98ee7595
2049888vancomycin 1250 MG InjectionSCD8eccafe8-40c9-495a-872d-7f45a98ee7595
2049890vancomycin 1500 MG InjectionSCD8eccafe8-40c9-495a-872d-7f45a98ee7595
1807516vancomycin 500 MG InjectionSCD8eccafe8-40c9-495a-872d-7f45a98ee7595
1807518vancomycin 750 MG InjectionSCD8eccafe8-40c9-495a-872d-7f45a98ee7595
1807513vancomycin (as vancomycin HCl) 1 GM InjectionSY8eccafe8-40c9-495a-872d-7f45a98ee7595
1807516vancomycin (as vancomycin HCl) 500 MG InjectionSY8eccafe8-40c9-495a-872d-7f45a98ee7595
1807513vancomycin 1 GM InjectionSY8eccafe8-40c9-495a-872d-7f45a98ee7595
2049888vancomycin 1.25 GM (as vancomycin hydrochloride 1.28 GM) InjectionSY8eccafe8-40c9-495a-872d-7f45a98ee7595
2049888vancomycin 1.25 GM InjectionSY8eccafe8-40c9-495a-872d-7f45a98ee7595
2049890vancomycin 1.5 GM (as vancomycin hydrochloride 1.54 GM) InjectionSY8eccafe8-40c9-495a-872d-7f45a98ee7595
2049890vancomycin 1.5 GM InjectionSY8eccafe8-40c9-495a-872d-7f45a98ee7595
1807518vancomycin 750 MG (as vancomycin hydrochloride 769 MG) InjectionSY8eccafe8-40c9-495a-872d-7f45a98ee7595

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0143-9161-0100143916101513 mg in 1 VIAL513 mgHistorical
0143-9161-100014391611010 VIAL in 1 PACKAGE (0143-9161-10) / 513 mg in 1 VIAL (0143-9161-01) 10 vial2024-12-03NoNoHistorical
0143-9161-250014391612525 VIAL in 1 PACKAGE (0143-9161-25) / 513 mg in 1 VIAL (0143-9161-01) 25 vial2023-02-02NoNoHistorical