Vancomycin Hydrochloride

Product NDC
0143-9358
11-digit product format
001439358
Labeler code
0143
Product ID
0143-9358_fcd91c44-1388-4e34-8078-678c1a640c9c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Vancomycin Hydrochloride
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA204360
Marketing category
ANDA
Marketing start
2018-10-15
Substance
VANCOMYCIN HYDROCHLORIDE
Active strength
5 g/1
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 g/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii71WO621TJD
Rxcui239209, 313572

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
0143-9358-01Vancomycin Hydrochloride1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9358-01EA - Each0143-93587cc0af7c-87fd-40fe-94cb-406122f9a45612019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9358VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.]4Current NDC, Legacy NDC, 1 package rows20211212_cae9e5f3-b89a-4a7f-93f7-9471c74a3559.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
239209vancomycin 100 MG/ML Injectable SolutionPSNcae9e5f3-b89a-4a7f-93f7-9471c74a35594
313572vancomycin 50 MG/ML Injectable SolutionPSNcae9e5f3-b89a-4a7f-93f7-9471c74a35594
239209vancomycin 100 MG/ML Injectable SolutionSCDcae9e5f3-b89a-4a7f-93f7-9471c74a35594
313572vancomycin 50 MG/ML Injectable SolutionSCDcae9e5f3-b89a-4a7f-93f7-9471c74a35594
239209vancomycin (as vancomycin hydrochloride) 100 MG/ML Injectable SolutionSYcae9e5f3-b89a-4a7f-93f7-9471c74a35594
313572vancomycin (as vancomycin hydrochloride) 50 MG/ML Injectable SolutionSYcae9e5f3-b89a-4a7f-93f7-9471c74a35594

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0143-9358-01001439358011 INJECTION, POWDER, FOR SOLUTION in 1 CARTON (0143-9358-01) 2018-10-150000-00-00NoNoCurrent