Vancomycin Hydrochloride for Oral Solution

Product NDC
52536-104
11-digit product format
525360104
Labeler code
52536
Product ID
52536-104_461e06ca-e37d-b9fd-e063-6394a90a5ce1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
vancomycin hydrochloride
Dosage form
KIT
Labeler
Wilshire Pharmaceuticals, Inc.
Application
NDA208910
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2023-03-31
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 for Oral Solution
Listing expiration
2026-12-31

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui2000127, 2000134

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
52536-104-05Vancomycin Hydrochloride for Oral Solution1 in 1 CARTONKIT13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52536-104-05ML - Milliliter52536-10449cbce04-5a1d-4e0a-b77d-72030686c25a12023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52536-104VANCOMYCIN HYDROCHLORIDE FOR ORAL SOLUTION (VANCOMYCIN HYDROCHLORIDE) KIT [WILSHIRE PHARMACEUTICALS, INC.]2Current NDC, 1 package rows20230331_4c3d2e99-5351-4442-916a-d2001b0a5f5a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2000127vancomycin 25 MG/mL Oral SolutionPSN4c3d2e99-5351-4442-916a-d2001b0a5f5a3
2000134vancomycin 50 MG/mL Oral SolutionPSN4c3d2e99-5351-4442-916a-d2001b0a5f5a3
2000127vancomycin 25 MG/ML Oral SolutionSCD4c3d2e99-5351-4442-916a-d2001b0a5f5a3
2000134vancomycin 50 MG/ML Oral SolutionSCD4c3d2e99-5351-4442-916a-d2001b0a5f5a3
2000127vancomycin (as vancomycin hydrochloride) 25 MG/ML Oral SolutionSY4c3d2e99-5351-4442-916a-d2001b0a5f5a3
2000134vancomycin (as vancomycin hydrochloride) 50 MG/ML Oral SolutionSY4c3d2e99-5351-4442-916a-d2001b0a5f5a3
2000134vancomycin 15 GM per 289 ML Powder for Oral SolutionSY4c3d2e99-5351-4442-916a-d2001b0a5f5a3
2000134vancomycin 250 MG per 5 ML Powder for Oral SolutionSY4c3d2e99-5351-4442-916a-d2001b0a5f5a3
2000127vancomycin 3.75 GM per 147 ML Powder for Oral SolutionSY4c3d2e99-5351-4442-916a-d2001b0a5f5a3
2000134vancomycin 7.5 GM per 145 ML Powder for Oral SolutionSY4c3d2e99-5351-4442-916a-d2001b0a5f5a3
2000127vancomycin 7.5 GM per 295 ML Powder for Oral SolutionSY4c3d2e99-5351-4442-916a-d2001b0a5f5a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
52536-104-05525360104051 KIT in 1 CARTON (52536-104-05) * 3.75 g in 1 BOTTLE (52536-094-05) * 147 mL in 1 BOTTLE (52536-084-05) 1 kit2023-03-31NoNoHistorical