Vancomycin Hydrochloride

Product NDC
51991-941
11-digit product format
519910941
Labeler code
51991
Product ID
51991-941_d5cc977d-305b-46da-ae64-d8351426886b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Vancomycin
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Breckenridge Pharmaceutical, Inc.
Application
ANDA205694
Marketing category
ANDA
Marketing start
2016-02-23
Marketing end
2021-04-30
Substance
VANCOMYCIN HYDROCHLORIDE
Active strength
1 g/1
Pharmacologic classes
Glycopeptide Antibacterial [EPC],Glycopeptides [CS]
NDC exclude flag
No
Listing certified through
0000-00-00
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 productproduct51991-941DDiscontinued by firm2026-08-17
excluded packagepackage51991-94151991-941-17DDiscontinued 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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51991-941-17d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51991-941-17f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51991-941-172ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage51991-941-17a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage51991-941-17cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage51991-941-17cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage51991-941-17302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage51991-941-17ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage51991-941-170efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage51991-941-17ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage51991-941-17367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage51991-941-17557ba5c1ecfa…9c80585c8c6e…

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A205694-001VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDEEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2016-01-21
A205694-002VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDEEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2016-01-21
A205694-003VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDEEQ 5GM BASE/VIALINJECTABLE / INJECTIONAP2023-06-06
A205694-004VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDEEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2023-06-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A205694-001AP
A205694-002AP
A205694-003AP
A205694-004AP

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 · 130 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A205694-001VANCOMYCIN HYDROCHLORIDEEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2016-01-21caaa826d4ba7…
2026-08-18 06:07:402026-07A205694-002VANCOMYCIN HYDROCHLORIDEEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2016-01-21caaa826d4ba7…
2026-08-18 06:07:402026-07A205694-003VANCOMYCIN HYDROCHLORIDEEQ 5GM BASE/VIALINJECTABLE / INJECTIONAP2023-06-06caaa826d4ba7…
2026-08-18 06:07:402026-07A205694-004VANCOMYCIN HYDROCHLORIDEEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2023-06-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A205694-001VANCOMYCIN HYDROCHLORIDEEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2016-01-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205694-002VANCOMYCIN HYDROCHLORIDEEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2016-01-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205694-003VANCOMYCIN HYDROCHLORIDEEQ 5GM BASE/VIALINJECTABLE / INJECTIONAP2023-06-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205694-004VANCOMYCIN HYDROCHLORIDEEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2023-06-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205694-001VANCOMYCIN HYDROCHLORIDEEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2016-01-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205694-002VANCOMYCIN HYDROCHLORIDEEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2016-01-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205694-003VANCOMYCIN HYDROCHLORIDEEQ 5GM BASE/VIALINJECTABLE / INJECTIONAP2023-06-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205694-004VANCOMYCIN HYDROCHLORIDEEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2023-06-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A205694-001VANCOMYCIN HYDROCHLORIDEEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2016-01-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205694-002VANCOMYCIN HYDROCHLORIDEEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2016-01-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205694-003VANCOMYCIN HYDROCHLORIDEEQ 5GM BASE/VIALINJECTABLE / INJECTIONAP2023-06-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205694-004VANCOMYCIN HYDROCHLORIDEEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2023-06-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205694-001VANCOMYCIN HYDROCHLORIDEEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2016-01-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205694-002VANCOMYCIN HYDROCHLORIDEEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2016-01-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205694-003VANCOMYCIN HYDROCHLORIDEEQ 5GM BASE/VIALINJECTABLE / INJECTIONAP2023-06-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205694-004VANCOMYCIN HYDROCHLORIDEEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2023-06-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205694-001VANCOMYCIN HYDROCHLORIDEEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2016-01-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205694-002VANCOMYCIN HYDROCHLORIDEEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2016-01-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205694-003VANCOMYCIN HYDROCHLORIDEEQ 5GM BASE/VIALINJECTABLE / INJECTIONAP2023-06-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205694-004VANCOMYCIN HYDROCHLORIDEEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2023-06-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205694-001VANCOMYCIN HYDROCHLORIDEEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2016-01-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205694-002VANCOMYCIN HYDROCHLORIDEEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2016-01-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205694-003VANCOMYCIN HYDROCHLORIDEEQ 5GM BASE/VIALINJECTABLE / INJECTIONAP2023-06-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205694-004VANCOMYCIN HYDROCHLORIDEEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2023-06-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205694-001VANCOMYCIN HYDROCHLORIDEEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2016-01-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205694-002VANCOMYCIN HYDROCHLORIDEEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2016-01-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205694-003VANCOMYCIN HYDROCHLORIDEEQ 5GM BASE/VIALINJECTABLE / INJECTIONAP2023-06-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205694-004VANCOMYCIN HYDROCHLORIDEEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2023-06-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205694-001VANCOMYCIN HYDROCHLORIDEEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2016-01-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205694-002VANCOMYCIN HYDROCHLORIDEEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2016-01-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205694-003VANCOMYCIN HYDROCHLORIDEEQ 5GM BASE/VIALINJECTABLE / INJECTIONAP2023-06-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205694-004VANCOMYCIN HYDROCHLORIDEEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2023-06-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205694-001VANCOMYCIN HYDROCHLORIDEEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2016-01-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205694-002VANCOMYCIN HYDROCHLORIDEEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2016-01-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205694-003VANCOMYCIN HYDROCHLORIDEEQ 5GM BASE/VIALINJECTABLE / INJECTIONAP2023-06-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205694-004VANCOMYCIN HYDROCHLORIDEEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2023-06-06d8e5a09893c0…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 130 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A205694-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A205694-002AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A205694-003AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A205694-004AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A205694-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205694-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205694-003AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205694-004AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205694-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205694-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205694-003AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205694-004AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A205694-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205694-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205694-003AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205694-004AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205694-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205694-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205694-003AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205694-004AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205694-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205694-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205694-003AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205694-004AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205694-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205694-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205694-003AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205694-004AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205694-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205694-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205694-003AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205694-004AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205694-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205694-002AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205694-003AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205694-004AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205694-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205694-002AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205694-003AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205694-004AP1d8e5a09893c0…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51991-941-17EA - Each51991-9411315aeac-0ac6-4969-9c70-4e8e71c3523812017-08-11
51991-941-99EA - Each51991-94180886863-cb1b-474f-a7a6-40fdff8516cc12018-01-12

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEGLENMARK PHARMACEUTICALS INC., USA74056e26-57fd-448e-af76-edbccfc3efb72026-04-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205694
application number: ANDA205694
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEGland Pharma Limited00946db3-d6c5-4534-a870-1ec6e63eda432026-01-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205694
application number: ANDA205694
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEXellia Pharmaceuticals USA LLC8403695c-3614-490b-9797-6c5ebcdeef9b2023-12-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205694
application number: ANDA205694
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEGland Pharma Limited35ecffbc-77d8-4c0d-9b14-6a3cc442dec62023-07-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205694
application number: ANDA205694
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDESagent Pharmaceuticals4843726f-6e79-6e20-2620-4a54616e64792023-06-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205694
application number: ANDA205694

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51991-941-175199109411710 VIAL, MULTI-DOSE in 1 CARTON (51991-941-17) > 1 INJECTION, SOLUTION in 1 VIAL, MULTI-DOSE (51991-941-99) 2017-04-282021-04-30NoNoCurrent