Vancomycin Hydrochloride

Product NDC
25021-151
11-digit product format
250210151
Labeler code
25021
Product ID
25021-151_9421f884-7b57-4a9a-8389-a45a70dd4598
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
vancomycin hydrochloride
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA205694
Marketing category
ANDA
Marketing start
2023-07-15
Substance
VANCOMYCIN HYDROCHLORIDE
Active strength
1 g/20mL
Pharmacologic classes
Glycopeptide Antibacterial [EPC], Glycopeptides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
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 · 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 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A205694-001VANCOMYCIN 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…
2024-10-29 15:01 UTC2024-10A205694-001VANCOMYCIN HYDROCHLORIDEEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2016-01-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A205694-002VANCOMYCIN HYDROCHLORIDEEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2016-01-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A205694-003VANCOMYCIN HYDROCHLORIDEEQ 5GM BASE/VIALINJECTABLE / INJECTIONAP2023-06-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A205694-004VANCOMYCIN HYDROCHLORIDEEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2023-06-06d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
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…
2024-10-29 15:01 UTC2024-10A205694-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A205694-002AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A205694-003AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A205694-004AP1d06236e962d9…

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
ndc (product): 25021-151

Additional Listing Data#

Finished product
Yes
Brand name base
Vancomycin Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VANCOMYCIN HYDROCHLORIDE1 g/20mL

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1807513Internal RxNorm lookup
1807516Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4843726f-6e79-6e20-2620-4a54616e6479Available 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
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
25021-151-20Vancomycin Hydrochloride20 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,207
25021-151-20Vancomycin Hydrochloride10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-151-20EA - Each25021-1511067056f-e647-4d89-bbb5-04c2a47a94a912023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-151VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SAGENT PHARMACEUTICALS]7Current NDC, 2 package rows20230715_4843726f-6e79-6e20-2620-4a54616e6479.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1807513vancomycin 1 GM InjectionPSN4843726f-6e79-6e20-2620-4a54616e64797
1807516vancomycin 500 MG InjectionPSN4843726f-6e79-6e20-2620-4a54616e64797
1807513vancomycin 1000 MG InjectionSCD4843726f-6e79-6e20-2620-4a54616e64797
1807516vancomycin 500 MG InjectionSCD4843726f-6e79-6e20-2620-4a54616e64797
1807513vancomycin (as vancomycin HCl) 1 GM InjectionSY4843726f-6e79-6e20-2620-4a54616e64797
1807516vancomycin (as vancomycin HCl) 500 MG InjectionSY4843726f-6e79-6e20-2620-4a54616e64797
1807513vancomycin 1 GM InjectionSY4843726f-6e79-6e20-2620-4a54616e64797

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
25021-151-202502101512010 VIAL in 1 CARTON (25021-151-20) / 20 mL in 1 VIAL10 vial2023-07-15NoNoCurrent