FDA.reportPublic FDA data

Vancomycin Hydrochloride

Product NDC
25021-150
11-digit product format
250210150
Labeler code
25021
Product ID
25021-150_9421f884-7b57-4a9a-8389-a45a70dd4598
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
vancomycin hydrochloride
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA205694
Marketing category
ANDA
Marketing start
2023-07-15
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
25021-150-10Vancomycin Hydrochloride10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,107
25021-150-10Vancomycin Hydrochloride10 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-150-10EA - Each25021-150c87ecc11-7100-41dd-a99b-d35eaf0738ef12023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-150VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SAGENT PHARMACEUTICALS]7Current NDC, 2 package rows20230715_4843726f-6e79-6e20-2620-4a54616e6479.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1807513vancomycin 1 GM InjectionPSN4843726f-6e79-6e20-2620-4a54616e64797
1807516vancomycin 500 MG InjectionPSN4843726f-6e79-6e20-2620-4a54616e64797
1807513vancomycin 1000 MG InjectionSCD4843726f-6e79-6e20-2620-4a54616e64797
1807516vancomycin 500 MG InjectionSCD4843726f-6e79-6e20-2620-4a54616e64797
1807513vancomycin (as vancomycin HCl) 1 GM InjectionSY4843726f-6e79-6e20-2620-4a54616e64797
1807516vancomycin (as vancomycin HCl) 500 MG InjectionSY4843726f-6e79-6e20-2620-4a54616e64797
1807513vancomycin 1 GM InjectionSY4843726f-6e79-6e20-2620-4a54616e64797

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
25021-150-102502101501010 VIAL in 1 CARTON (25021-150-10) / 10 mL in 1 VIAL10 vial2023-07-15NoNoHistorical