Vancomycin Hydrochloride

Product NDC
66288-7100
11-digit product format
662887100
Labeler code
66288
Product ID
66288-7100_d607785f-563a-4816-83c4-dfc38bbc29bd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Vancomycin Hydrochloride
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
SAMSON MEDICAL TECHNOLOGIES LLC
Application
ANDA091532
Marketing category
ANDA
Marketing start
2016-06-01
Substance
VANCOMYCIN HYDROCHLORIDE
Active strength
100 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 HYDROCHLORIDE100 g/1

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
66288-7100-1Vancomycin Hydrochloride1 in 1 BAGINJECTION, POWDER, LYOPHILIZED,15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66288-7100-1EA - Each66288-710014c24c0c-05ca-4058-af26-2a5df03267e412017-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66288-7100VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SAMSON MEDICAL TECHNOLOGIES LLC]5Current NDC, Legacy NDC, 1 package rows20201130_93589e71-3a11-4797-9176-8abdb7674a87.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
239209vancomycin 100 MG/ML Injectable SolutionPSN93589e71-3a11-4797-9176-8abdb7674a875
239209vancomycin 100 MG/ML Injectable SolutionSCD93589e71-3a11-4797-9176-8abdb7674a875
239209vancomycin (as vancomycin hydrochloride) 100 MG/ML Injectable SolutionSY93589e71-3a11-4797-9176-8abdb7674a875

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66288-7100-1662887100011 BAG in 1 BAG (66288-7100-1) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 BAG1 bag2016-06-010000-00-00NoNoCurrent