FDA.reportPublic FDA data

Vancomycin Hydrochloride

Product NDC
43538-805
11-digit product format
435380805
Labeler code
43538
Product ID
43538-805_1ad6b244-4759-43d1-aae0-81580193759e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Vancomycin hydrochloride
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Medimetriks Pharmaceuticals, Inc.
Application
ANDA065401
Marketing category
ANDA
Marketing start
2008-06-30
Substance
VANCOMYCIN HYDROCHLORIDE
Active strength
500 mg/10mL
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 HYDROCHLORIDE500 mg/10mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii71WO621TJD
Rxcui1807513, 1807516

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
43538-805-01Vancomycin Hydrochloride10 mL in 1 VIAL, GLASSINJECTION, POWDER, LYOPHILIZED,101
43538-805-10Vancomycin Hydrochloride10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43538-805-01EA - Each43538-8057e86d4e2-e0e7-4ee8-ad2a-7815f12466e912025-11-13
43538-805-10EA - Each43538-80545c50085-9bb3-4043-820e-0f6509f86d6512025-11-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43538-805VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MEDIMETRIKS PHARMACEUTICALS, INC.]1Current NDC, 2 package rows20250411_826510bd-b611-42d9-a574-ec7ee4151ef5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1807513vancomycin 1 GM InjectionPSN826510bd-b611-42d9-a574-ec7ee4151ef51
1807516vancomycin 500 MG InjectionPSN826510bd-b611-42d9-a574-ec7ee4151ef51
1807513vancomycin 1000 MG InjectionSCD826510bd-b611-42d9-a574-ec7ee4151ef51
1807516vancomycin 500 MG InjectionSCD826510bd-b611-42d9-a574-ec7ee4151ef51
1807513vancomycin (as vancomycin HCl) 1 GM InjectionSY826510bd-b611-42d9-a574-ec7ee4151ef51
1807516vancomycin (as vancomycin HCl) 500 MG InjectionSY826510bd-b611-42d9-a574-ec7ee4151ef51
1807513vancomycin 1 GM InjectionSY826510bd-b611-42d9-a574-ec7ee4151ef51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
43538-805-014353808050110 mL in 1 VIAL, GLASS10 mlHistorical
43538-805-104353808051010 VIAL, GLASS in 1 CARTON (43538-805-10) / 10 mL in 1 VIAL, GLASS (43538-805-01) 2025-04-02NoNoHistorical