Application 050671

Type
NDA
Sponsor
BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINERVANCOMYCIN HYDROCHLORIDEINJECTABLE;INJECTIONEQ 500MG BASE/100MLYesYes
002VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINERVANCOMYCIN HYDROCHLORIDEINJECTABLE;INJECTIONEQ 750MG BASE/150MLYesYes
003VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINERVANCOMYCIN HYDROCHLORIDEINJECTABLE;INJECTIONEQ 1GM BASE/200MLYesYes
004VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINERVANCOMYCIN HYDROCHLORIDESOLUTION;INTRAVENOUSEQ 1.25GM BASE/250ML (EQ 5MG BASE/ML)YesYes
005VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINERVANCOMYCIN HYDROCHLORIDESOLUTION;INTRAVENOUSEQ 1.5GM BASE/300ML (EQ 5MG BASE/ML)YesYes

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…

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 (product): 0338-3552
ndc (product): 0338-3580
ndc (product): 0338-3581
ndc (product): 0338-3551
ndc (product): 0338-3582
ndc (product): 0338-3583

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 30 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0338-3551VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDEBaxter Healthcare CorporationNDACurrent
0338-3551VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDEBaxter Healthcare CorporationNDACurrent
0338-3551VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDEBaxter Healthcare CorporationNDACurrent
0338-3551VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDEBaxter Healthcare CorporationNDACurrent
0338-3551VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDEBaxter Healthcare CorporationNDACurrent
0338-3552VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDEBaxter Healthcare CorporationNDACurrent
0338-3552VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDEBaxter Healthcare CorporationNDACurrent
0338-3552VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDEBaxter Healthcare CorporationNDACurrent
0338-3552VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDEBaxter Healthcare CorporationNDACurrent
0338-3552VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDEBaxter Healthcare CorporationNDACurrent
0338-3580VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDEBaxter Healthcare CorporationNDACurrent
0338-3580VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDEBaxter Healthcare CorporationNDACurrent
0338-3580VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDEBaxter Healthcare CorporationNDACurrent
0338-3580VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDEBaxter Healthcare CorporationNDACurrent
0338-3580VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDEBaxter Healthcare CorporationNDACurrent
0338-3581VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDEBaxter Healthcare CorporationNDACurrent
0338-3581VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDEBaxter Healthcare CorporationNDACurrent
0338-3581VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDEBaxter Healthcare CorporationNDACurrent
0338-3581VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDEBaxter Healthcare CorporationNDACurrent
0338-3581VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDEBaxter Healthcare CorporationNDACurrent
0338-3582VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDEBaxter Healthcare CorporationNDACurrent
0338-3582VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDEBaxter Healthcare CorporationNDACurrent
0338-3582VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDEBaxter Healthcare CorporationNDACurrent
0338-3582VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDEBaxter Healthcare CorporationNDACurrent
0338-3582VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDEBaxter Healthcare CorporationNDACurrent
0338-3583VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDEBaxter Healthcare CorporationNDACurrent
0338-3583VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDEBaxter Healthcare CorporationNDACurrent
0338-3583VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDEBaxter Healthcare CorporationNDACurrent
0338-3583VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDEBaxter Healthcare CorporationNDACurrent
0338-3583VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDEBaxter Healthcare CorporationNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82368ORIG 2025-05-30
82367SUPPL 2025-05-30
82361SUPPL 2025-05-30
78752SUPPL 2024-07-02
78760SUPPL 2024-06-10
66045SUPPL2021-02-01
66031SUPPL2021-02-01
49893SUPPL2017-09-29
49879SUPPL2017-09-29
46852SUPPL2017-01-17
46767SUPPL2017-01-06
17999SUPPL2015-12-28
7966SUPPL2015-12-22
17998SUPPL2012-01-23
7965SUPPL2012-01-19
39086SUPPL2009-04-03
30250SUPPL2009-03-13
39085SUPPL2008-05-08
7964SUPPL2008-05-07
30249SUPPL2007-09-25
39084SUPPL2007-09-19
7963SUPPL2004-04-07
17997SUPPL2004-04-05
42672SUPPL1998-01-08
42671SUPPL1998-01-08