Vancomycin

Product NDC
70594-040
11-digit product format
705940040
Labeler code
70594
Product ID
70594-040_5132e864-353a-4050-b02d-b4417fd51e41
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Vancomycin
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Xellia Pharmaceuticals USA LLC
Application
NDA213895
Marketing category
NDA
Marketing start
2021-08-26
Marketing end
0000-00-00
Substance
VANCOMYCIN
Active strength
5 g/100mL
Pharmacologic classes
Glycopeptide Antibacterial [EPC],Glycopeptides [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct70594-040DDiscontinued by firm2026-08-17
excluded packagepackage70594-04070594-040-01DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 23 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70594-040-01DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70594-040-01DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70594-040-01DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70594-040-01DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70594-040-01DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70594-040-01DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70594-040-01DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70594-040-01DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70594-040-01DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70594-040-01DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70594-040-01DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage70594-040-01DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N213895-001VANCOMYCINVANCOMYCIN5GM/100ML (50MG/ML)SOLUTION / INTRAVENOUS, ORALRLD2021-08-26

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N213895-001100398042035-11-06U-282Drug product2021-09-14
N213895-001101886972035-11-06U-282Drug product2021-09-14
N213895-001108499562035-11-06Drug product2021-09-14
N213895-001110005672035-11-06Drug product2021-09-14
N213895-001115176092035-11-06U-2822023-03-31

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N213895-001VANCOMYCIN5GM/100ML (50MG/ML)SOLUTION / INTRAVENOUS, ORALRLD2021-08-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N213895-001VANCOMYCIN5GM/100ML (50MG/ML)SOLUTION / INTRAVENOUS, ORALRLD2021-08-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213895-001VANCOMYCIN5GM/100ML (50MG/ML)SOLUTION / INTRAVENOUS, ORALRLD2021-08-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08N213895-001VANCOMYCIN5GM/100ML (50MG/ML)SOLUTION / INTRAVENOUS, ORALRLD2021-08-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N213895-001VANCOMYCIN5GM/100ML (50MG/ML)SOLUTION / INTRAVENOUS, ORALRLD2021-08-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N213895-001VANCOMYCIN5GM/100ML (50MG/ML)SOLUTION / INTRAVENOUS, ORALRLD2021-08-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N213895-001VANCOMYCIN5GM/100ML (50MG/ML)SOLUTION / INTRAVENOUS, ORALRLD2021-08-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N213895-001VANCOMYCIN5GM/100ML (50MG/ML)SOLUTION / INTRAVENOUS, ORALRLD2021-08-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N213895-001VANCOMYCIN5GM/100ML (50MG/ML)SOLUTION / INTRAVENOUS, ORALRLD2021-08-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N213895-001VANCOMYCIN5GM/100ML (50MG/ML)SOLUTION / INTRAVENOUS, ORALRLD2021-08-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N213895-001VANCOMYCIN5GM/100ML (50MG/ML)SOLUTION / INTRAVENOUS, ORALRLD2021-08-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N213895-001VANCOMYCIN5GM/100ML (50MG/ML)SOLUTION / INTRAVENOUS, ORALRLD2021-08-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N213895-001VANCOMYCIN5GM/100ML (50MG/ML)SOLUTION / INTRAVENOUS, ORALRLD2021-08-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N213895-001VANCOMYCIN5GM/100ML (50MG/ML)SOLUTION / INTRAVENOUS, ORALRLD2021-08-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05N213895-001VANCOMYCIN5GM/100ML (50MG/ML)SOLUTION / INTRAVENOUS, ORALRLD2021-08-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N213895-001VANCOMYCIN5GM/100ML (50MG/ML)SOLUTION / INTRAVENOUS, ORALRLD, RS2021-08-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N213895-001VANCOMYCIN5GM/100ML (50MG/ML)SOLUTION / INTRAVENOUS, ORALRLD, RS2021-08-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N213895-001VANCOMYCIN5GM/100ML (50MG/ML)SOLUTION / INTRAVENOUS, ORALRLD, RS2021-08-264b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N213895-001VANCOMYCIN5GM/100ML (50MG/ML)SOLUTION / INTRAVENOUS, ORALRLD, RS2021-08-26bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N213895-001VANCOMYCIN5GM/100ML (50MG/ML)SOLUTION / INTRAVENOUS, ORALRLD, RS2021-08-26782e0a99824c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N213895-001VANCOMYCIN5GM/100ML (50MG/ML)SOLUTION / INTRAVENOUS, ORALRLD2021-08-266a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N213895-001VANCOMYCIN5GM/100ML (50MG/ML)SOLUTION / INTRAVENOUS, ORALRLD2021-08-261c564ffb4f44…
2023-12-20 04:57 UTC2023-12N213895-001VANCOMYCIN5GM/100ML (50MG/ML)SOLUTION / INTRAVENOUS, ORALRLD2021-08-26ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N213895-001VANCOMYCIN5GM/100ML (50MG/ML)SOLUTION / INTRAVENOUS, ORALRLD2021-08-26a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N213895-001VANCOMYCIN5GM/100ML (50MG/ML)SOLUTION / INTRAVENOUS, ORALRLD, RS2021-08-269b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N213895-001VANCOMYCIN5GM/100ML (50MG/ML)SOLUTION / INTRAVENOUS, ORALRLD, RS2021-08-26a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N213895-001VANCOMYCIN5GM/100ML (50MG/ML)SOLUTION / INTRAVENOUS, ORALRLD, RS2021-08-263f0d92c62455…
2023-05-13 08:27 UTC2023-05N213895-001VANCOMYCIN5GM/100ML (50MG/ML)SOLUTION / INTRAVENOUS, ORALRLD, RS2021-08-26053a50430f4f…
2023-01-26 05:58 UTC2023-01N213895-001VANCOMYCIN5GM/100ML (50MG/ML)SOLUTION / INTRAVENOUS, ORALRLD, RS2021-08-263bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N213895-001VANCOMYCIN5GM/100ML (50MG/ML)SOLUTION / INTRAVENOUS, ORALRLD, RS2021-08-263a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N213895-001VANCOMYCIN5GM/100ML (50MG/ML)SOLUTION / INTRAVENOUS, ORALRLD, RS2021-08-26f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N213895-001VANCOMYCIN5GM/100ML (50MG/ML)SOLUTION / INTRAVENOUS, ORALRLD, RS2021-08-26e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N213895-001VANCOMYCIN5GM/100ML (50MG/ML)SOLUTION / INTRAVENOUS, ORALRLD, RS2021-08-26cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N213895-001VANCOMYCIN5GM/100ML (50MG/ML)SOLUTION / INTRAVENOUS, ORALRLD2021-08-26a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 4 · 160 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-18 06:07:402026-07N213895-001100398042035-11-06U-282Drug product2021-09-14caaa826d4ba7…
2026-08-18 06:07:402026-07N213895-001101886972035-11-06U-282Drug product2021-09-14caaa826d4ba7…
2026-08-18 06:07:402026-07N213895-001108499562035-11-06Drug product2021-09-14caaa826d4ba7…
2026-08-18 06:07:402026-07N213895-001110005672035-11-06Drug product2021-09-14caaa826d4ba7…
2026-08-18 06:07:402026-07N213895-001115176092035-11-06U-2822023-03-31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N213895-001100398042035-11-06U-282Drug product2021-09-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213895-001101886972035-11-06U-282Drug product2021-09-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213895-001108499562035-11-06Drug product2021-09-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213895-001110005672035-11-06Drug product2021-09-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213895-001115176092035-11-06U-2822023-03-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213895-001100398042035-11-06U-282Drug product2021-09-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213895-001101886972035-11-06U-282Drug product2021-09-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213895-001108499562035-11-06Drug product2021-09-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213895-001110005672035-11-06Drug product2021-09-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213895-001115176092035-11-06U-2822023-03-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08N213895-001100398042035-11-06U-282Drug product2021-09-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08N213895-001101886972035-11-06U-282Drug product2021-09-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08N213895-001108499562035-11-06Drug product2021-09-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08N213895-001110005672035-11-06Drug product2021-09-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08N213895-001115176092035-11-06U-2822023-03-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N213895-001100398042035-11-06U-282Drug product2021-09-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N213895-001101886972035-11-06U-282Drug product2021-09-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N213895-001108499562035-11-06Drug product2021-09-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N213895-001110005672035-11-06Drug product2021-09-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N213895-001115176092035-11-06U-2822023-03-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N213895-001100398042035-11-06U-282Drug product2021-09-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N213895-001101886972035-11-06U-282Drug product2021-09-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N213895-001108499562035-11-06Drug product2021-09-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N213895-001110005672035-11-06Drug product2021-09-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N213895-001115176092035-11-06U-2822023-03-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N213895-001100398042035-11-06U-282Drug product2021-09-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N213895-001101886972035-11-06U-282Drug product2021-09-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N213895-001108499562035-11-06Drug product2021-09-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N213895-001110005672035-11-06Drug product2021-09-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N213895-001115176092035-11-06U-2822023-03-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N213895-001100398042035-11-06U-282Drug product2021-09-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N213895-001101886972035-11-06U-282Drug product2021-09-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N213895-001108499562035-11-06Drug product2021-09-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N213895-001110005672035-11-06Drug product2021-09-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N213895-001115176092035-11-06U-2822023-03-312680178bc6a6…

FDA-Initiated Inactive NDC Indexing#

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70594-040-01705940040011 VIAL in 1 CARTON (70594-040-01) > 100 mL in 1 VIAL1 vial2021-08-260000-00-00NoNoCurrent