VANCOMYCIN HYDROCHLORIDE

Product NDC
0338-3583
Requested package NDC
0338-3583-01
11-digit product format
003383583
Labeler code
0338
Product ID
0338-3583_4e548f07-0e95-4ae7-bda2-176cb4a781fd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
VANCOMYCIN HYDROCHLORIDE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Baxter Healthcare Corporation
Application
NDA050671
Marketing category
NDA
Marketing start
1958-11-14
Substance
VANCOMYCIN HYDROCHLORIDE
Active strength
1 g/200mL
Pharmacologic classes
Glycopeptide Antibacterial [EPC], Glycopeptides [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N050671-001VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINERVANCOMYCIN HYDROCHLORIDEEQ 500MG BASE/100ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS1993-04-29
N050671-002VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINERVANCOMYCIN HYDROCHLORIDEEQ 750MG BASE/150ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2010-12-20
N050671-003VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINERVANCOMYCIN HYDROCHLORIDEEQ 1GM BASE/200ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS1999-03-01
N050671-004VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINERVANCOMYCIN HYDROCHLORIDEEQ 1.25GM BASE/250ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2024-01-25
N050671-005VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINERVANCOMYCIN HYDROCHLORIDEEQ 1.5GM BASE/300ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2024-01-25

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 155 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N050671-001VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINEREQ 500MG BASE/100ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS1993-04-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N050671-002VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINEREQ 750MG BASE/150ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2010-12-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N050671-003VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINEREQ 1GM BASE/200ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS1999-03-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02N050671-004VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINEREQ 1.25GM BASE/250ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2024-01-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N050671-005VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINEREQ 1.5GM BASE/300ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2024-01-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050671-001VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINEREQ 500MG BASE/100ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS1993-04-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050671-002VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINEREQ 750MG BASE/150ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2010-12-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050671-003VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINEREQ 1GM BASE/200ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS1999-03-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050671-004VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINEREQ 1.25GM BASE/250ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2024-01-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050671-005VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINEREQ 1.5GM BASE/300ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2024-01-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08N050671-001VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINEREQ 500MG BASE/100ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS1993-04-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050671-002VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINEREQ 750MG BASE/150ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2010-12-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050671-003VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINEREQ 1GM BASE/200ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS1999-03-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050671-004VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINEREQ 1.25GM BASE/250ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2024-01-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050671-005VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINEREQ 1.5GM BASE/300ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2024-01-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050671-001VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINEREQ 500MG BASE/100ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS1993-04-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050671-002VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINEREQ 750MG BASE/150ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2010-12-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050671-003VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINEREQ 1GM BASE/200ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS1999-03-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050671-004VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINEREQ 1.25GM BASE/250ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2024-01-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050671-005VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINEREQ 1.5GM BASE/300ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2024-01-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050671-001VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINEREQ 500MG BASE/100ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS1993-04-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050671-002VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINEREQ 750MG BASE/150ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2010-12-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050671-003VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINEREQ 1GM BASE/200ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS1999-03-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050671-004VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINEREQ 1.25GM BASE/250ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2024-01-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050671-005VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINEREQ 1.5GM BASE/300ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2024-01-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050671-001VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINEREQ 500MG BASE/100ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS1993-04-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050671-002VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINEREQ 750MG BASE/150ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2010-12-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050671-003VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINEREQ 1GM BASE/200ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS1999-03-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050671-004VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINEREQ 1.25GM BASE/250ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2024-01-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050671-005VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINEREQ 1.5GM BASE/300ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2024-01-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050671-001VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINEREQ 500MG BASE/100ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS1993-04-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050671-002VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINEREQ 750MG BASE/150ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2010-12-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050671-003VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINEREQ 1GM BASE/200ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS1999-03-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050671-004VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINEREQ 1.25GM BASE/250ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2024-01-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050671-005VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINEREQ 1.5GM BASE/300ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2024-01-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050671-001VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINEREQ 500MG BASE/100ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS1993-04-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050671-002VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINEREQ 750MG BASE/150ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2010-12-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050671-003VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINEREQ 1GM BASE/200ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS1999-03-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050671-004VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINEREQ 1.25GM BASE/250ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2024-01-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050671-005VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINEREQ 1.5GM BASE/300ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2024-01-255bbf6a4d5a75…

Additional Listing Data#

Finished product
Yes
Brand name base
VANCOMYCIN HYDROCHLORIDE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VANCOMYCIN HYDROCHLORIDE1 g/200mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
71WO621TJDInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1807508Internal RxNorm lookup
1807510Internal RxNorm lookup
1807511Internal RxNorm lookup
2118448Internal RxNorm lookup
2387078Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
99e523d8-9bde-43cb-8434-497015e5dcbdAvailable on FDA.report

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
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
e5c5573a-2fda-453b-9d65-c6185b588ecdProduct name520220613
3a86dfd0-ed28-4976-b9ec-00923fbfbdd4Product name120220308
5d603187-d384-6e74-5fc7-30310b2b3c99Product name320190717
bec007f0-8cd6-4f79-a3df-c0d94ebb2a36Product name120190614
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
f4fec0bc-aaaa-4c5c-aa2b-21daf18ef477Product name120160209
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
a0c54c75-e1f1-eb4f-25c4-be91c2fe237dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0338-3583-01VANCOMYCIN HYDROCHLORIDE200 mL in 1 BAGINJECTION, SOLUTION20026

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0338-3583-01ML - Milliliter0338-35835fb4aaf4-3fc5-4058-ad27-30fed41dc71b12016-05-16

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0338-3583VANCOMYCIN HYDROCHLORIDE INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]24Current NDC, Legacy NDC, 1 package rows20240622_99e523d8-9bde-43cb-8434-497015e5dcbd.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDEBaxter Healthcare Corporation99e523d8-9bde-43cb-8434-497015e5dcbd2026-06-09Warnings, Adverse reactionsExact identifier
application applno (NDA): 050671
application number: NDA050671
ndc (package): 0338-3583-01
ndc (product): 0338-3583
ndc11 (package): 00338358301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1807508vancomycin 1 GM in 200 ML InjectionPSN99e523d8-9bde-43cb-8434-497015e5dcbd26
2387078vancomycin 1.25 GM in 250 ML InjectionPSN99e523d8-9bde-43cb-8434-497015e5dcbd26
2118448vancomycin 1.5 GM in 300 ML InjectionPSN99e523d8-9bde-43cb-8434-497015e5dcbd26
1807511vancomycin 500 MG in 100 ML InjectionPSN99e523d8-9bde-43cb-8434-497015e5dcbd26
1807510vancomycin 750 MG in 150 ML InjectionPSN99e523d8-9bde-43cb-8434-497015e5dcbd26
1807511100 ML vancomycin 5 MG/ML InjectionSCD99e523d8-9bde-43cb-8434-497015e5dcbd26
1807510150 ML vancomycin 5 MG/ML InjectionSCD99e523d8-9bde-43cb-8434-497015e5dcbd26
1807508200 ML vancomycin 5 MG/ML InjectionSCD99e523d8-9bde-43cb-8434-497015e5dcbd26
2387078250 ML vancomycin 5 MG/ML InjectionSCD99e523d8-9bde-43cb-8434-497015e5dcbd26
2118448300 ML vancomycin 5 MG/ML InjectionSCD99e523d8-9bde-43cb-8434-497015e5dcbd26
2118448vancomycin (as vancomycin HCl) 1.5 GM per 300 ML InjectionSY99e523d8-9bde-43cb-8434-497015e5dcbd26
1807511vancomycin (as vancomycin HCl) 500 MG per 100 ML InjectionSY99e523d8-9bde-43cb-8434-497015e5dcbd26
1807508vancomycin (as vancomycin hydrochloride) 1 GM per 200 ML InjectionSY99e523d8-9bde-43cb-8434-497015e5dcbd26
1807510vancomycin (as vancomycin hydrochloride) 750 MG per 150 ML InjectionSY99e523d8-9bde-43cb-8434-497015e5dcbd26
1807508vancomycin 1 GM per 200 ML InjectionSY99e523d8-9bde-43cb-8434-497015e5dcbd26
2387078vancomycin 1.25 GM per 250 ML InjectionSY99e523d8-9bde-43cb-8434-497015e5dcbd26
2118448vancomycin 1.5 GM per 300 ML InjectionSY99e523d8-9bde-43cb-8434-497015e5dcbd26
2387078vancomycin 1250 MG per 250 ML InjectionSY99e523d8-9bde-43cb-8434-497015e5dcbd26
1807511vancomycin 500 MG per 100 ML InjectionSY99e523d8-9bde-43cb-8434-497015e5dcbd26
1807510vancomycin 750 MG per 150 ML InjectionSY99e523d8-9bde-43cb-8434-497015e5dcbd26

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0338-3583-0100338358301200 mL in 1 BAG (0338-3583-01) 200 ml2015-12-180000-00-00NoNoCurrent