Vancomycin Hydrochloride

Product NDC
87188-203
11-digit product format
871880203
Labeler code
87188
Product ID
87188-203_4b9d2f3d-05d6-15eb-e063-6294a90a08c8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Vancomycin Hydrochloride
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Plano Pharmaceuticals Inc.
Application
ANDA201048
Marketing category
ANDA
Marketing start
2012-08-10
Substance
VANCOMYCIN HYDROCHLORIDE
Active strength
5 g/100mL
Pharmacologic classes
Glycopeptide Antibacterial [EPC], Glycopeptides [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Vancomycin Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VANCOMYCIN HYDROCHLORIDE5 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii71WO621TJD
Rxcui313572

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
87188-203-01Vancomycin Hydrochloride100 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,1002
87188-203-01Vancomycin Hydrochloride1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313572vancomycin 50 MG/ML Injectable SolutionPSN4983f60c-0f7b-d427-e063-6394a90a838c2
313572vancomycin 50 MG/ML Injectable SolutionSCD4983f60c-0f7b-d427-e063-6394a90a838c2
313572vancomycin (as vancomycin hydrochloride) 50 MG/ML Injectable SolutionSY4983f60c-0f7b-d427-e063-6394a90a838c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
87188-203-01871880203011 VIAL in 1 CARTON (87188-203-01) / 100 mL in 1 VIAL1 vial2012-08-10YesNoCurrent