vancomycin hydrochloride

Product NDC
80425-0514
11-digit product format
804250514
Labeler code
80425
Product ID
80425-0514_331277b8-8300-d082-e063-6394a90a4dd3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
vancomycin hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Advanced Rx of Tennessee, LLC
Application
NDA050606
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2025-04-18
Substance
VANCOMYCIN HYDROCHLORIDE
Active strength
250 mg/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 HYDROCHLORIDE250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii71WO621TJD
Rxcui313571

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
80425-0514-1vancomycin hydrochloride20 in 1 BOTTLECAPSULE201
80425-0514-2vancomycin hydrochloride30 in 1 BOTTLECAPSULE301
80425-0514-3vancomycin hydrochloride60 in 1 BOTTLECAPSULE601
80425-0514-4vancomycin hydrochloride90 in 1 BOTTLECAPSULE901
80425-0514-5vancomycin hydrochloride40 in 1 BOTTLECAPSULE401
80425-0514-6vancomycin hydrochloride50 in 1 BOTTLECAPSULE501

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0514-1EA - Each80425-0514aec4f12e-c6f3-4c0a-ade8-b406c9751afc12025-05-14
80425-0514-2EA - Each80425-0514c777bbbe-a70e-4352-88ed-0b2fedf1a13512025-05-14
80425-0514-3EA - Each80425-0514aa0d4003-7f73-4f6d-94c3-6572eec359a812025-05-14
80425-0514-4EA - Each80425-05141ec697fd-1470-4225-8ab1-60dfeb11710312025-05-14
80425-0514-5EA - Each80425-0514a6eefa42-45c3-4a28-bf5a-62b41462aaca12025-05-14
80425-0514-6EA - Each80425-0514de11cd8c-e71f-4c5a-ad32-0b531bc52d4112025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0514VANCOMYCIN HYDROCHLORIDE CAPSULE [ADVANCED RX OF TENNESSEE, LLC]1Current NDC, 6 package rows20250420_33127951-1fad-15c1-e063-6294a90a6996.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313571vancomycin HCl 250 MG Oral CapsulePSN33127951-1fad-15c1-e063-6294a90a69961
313571vancomycin 250 MG Oral CapsuleSCD33127951-1fad-15c1-e063-6294a90a69961
313571vancomycin (as vancomycin hydrochloride) 250 MG Oral CapsuleSY33127951-1fad-15c1-e063-6294a90a69961

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80425-0514-18042505140120 CAPSULE in 1 BOTTLE (80425-0514-1) 20 capsule2025-04-18NoNoHistorical
80425-0514-28042505140230 CAPSULE in 1 BOTTLE (80425-0514-2) 30 capsule2025-04-18NoNoHistorical
80425-0514-38042505140360 CAPSULE in 1 BOTTLE (80425-0514-3) 60 capsule2025-04-18NoNoHistorical
80425-0514-48042505140490 CAPSULE in 1 BOTTLE (80425-0514-4) 90 capsule2025-04-18NoNoHistorical
80425-0514-58042505140540 CAPSULE in 1 BOTTLE (80425-0514-5) 40 capsule2025-04-18NoNoHistorical
80425-0514-68042505140650 CAPSULE in 1 BOTTLE (80425-0514-6) 50 capsule2025-04-18NoNoHistorical