Home NDC 63323-221 Vancomycin Hydrochloride
Product NDC 63323-221
11-digit product format 633230221
Labeler code 63323
Product ID 63323-221_0ab54d7b-de6b-412f-b2b5-a8522f78f3c4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Vancomycin Hydrochloride
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Fresenius Kabi, LLC
Application ANDA204107
Marketing category ANDA
Marketing start 2017-11-01
Substance VANCOMYCIN HYDROCHLORIDE
Active strength 500 mg/10mL
Pharmacologic classes Glycopeptide Antibacterial [EPC], Glycopeptides [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 10 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A204107-001 VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-12-28 A204107-002 VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2015-12-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 3 · 82 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A204107-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-12-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204107-002 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2015-12-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204107-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-12-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204107-002 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2015-12-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204107-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-12-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204107-002 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2015-12-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204107-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-12-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204107-002 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2015-12-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204107-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-12-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204107-002 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2015-12-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204107-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-12-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204107-002 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2015-12-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204107-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-12-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204107-002 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2015-12-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204107-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-12-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204107-002 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2015-12-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204107-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-12-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204107-002 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2015-12-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204107-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-12-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204107-002 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2015-12-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204107-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-12-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204107-002 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2015-12-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204107-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-12-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204107-002 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2015-12-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204107-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-12-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204107-002 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2015-12-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204107-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-12-28 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A204107-002 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2015-12-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204107-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-12-28 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204107-002 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2015-12-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204107-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-12-28 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A204107-002 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2015-12-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204107-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-12-28 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A204107-002 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2015-12-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204107-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-12-28 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A204107-002 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2015-12-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204107-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-12-28 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A204107-002 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2015-12-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204107-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-12-28 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A204107-002 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2015-12-28 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Vancomycin Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength VANCOMYCIN HYDROCHLORIDE 500 mg/10mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 71WO621TJD Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1807516 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63323-221-01 VANCOMYCIN HYDROCHLORIDE 10 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 10 17 63323-221-10 VANCOMYCIN HYDROCHLORIDE 25 in 1 TRAY INJECTION, POWDER, LYOPHILIZED, 25 17 63323-221-16 VANCOMYCIN HYDROCHLORIDE 25 in 1 TRAY INJECTION, POWDER, LYOPHILIZED, 25 8 63323-221-41 VANCOMYCIN HYDROCHLORIDE 10 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 10 8 63323-221-33 Vancomycin Hydrochloride 10 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 10 6 63323-221-38 Vancomycin Hydrochloride 25 in 1 TRAY INJECTION, POWDER, LYOPHILIZED, 25 6 63323-221-43 Vancomycin Hydrochloride 10 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 10 5 63323-221-48 Vancomycin Hydrochloride 25 in 1 TRAY INJECTION, POWDER, LYOPHILIZED, 25 5
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded VANCOMYCIN HYDROCHLORIDE ACTIVE INGREDIENT 71WO621TJD VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [APP PHARMACEUTICALS, LLC] 3 VANCOMYCIN ACTIVE MOIETY 6Q205EH1VU VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [APP PHARMACEUTICALS, LLC] 3 VANCOMYCIN HYDROCHLORIDE ACTIVE INGREDIENT 71WO621TJD VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 1 VANCOMYCIN ACTIVE MOIETY 6Q205EH1VU VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63323-221 VANCOMYCIN HYDROCHLORIDE (VANCOMYCIN HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC
] 16 Current NDC, Legacy NDC, 2 package rows 20240328_f604d399-fded-4f4f-8efe-af558ed07b9d.zip 63323-221 VANCOMYCIN HYDROCHLORIDE (VANCOMYCIN HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC
] 8 Current NDC, Legacy NDC, 2 package rows 20240404_0576803d-95de-4a48-806a-69ae3fcaf6b0.zip 63323-221 VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI, LLC] 6 Current NDC, Legacy NDC, 2 package rows 20221209_8a35ebee-8650-4ef5-84f5-ab9b55d9bc19.zip 63323-221 VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI, LLC] 5 Current NDC, Legacy NDC, 2 package rows 20221209_418c3c6a-d08d-448c-89c9-54e558c1ce16.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE Fresenius Kabi USA, LLC f604d399-fded-4f4f-8efe-af558ed07b9d 2025-05-15 Warnings, Adverse reactions Exact identifier ndc (product): 63323-221 VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE Fresenius Kabi USA, LLC 0576803d-95de-4a48-806a-69ae3fcaf6b0 2023-08-17 Warnings, Adverse reactions Exact identifier ndc (product): 63323-221 Vancomycin Hydrochloride VANCOMYCIN HYDROCHLORIDE Fresenius Kabi, LLC 8a35ebee-8650-4ef5-84f5-ab9b55d9bc19 2022-12-02 Warnings, Adverse reactions Exact identifier application applno (ANDA): 204107 application number: ANDA204107 ndc (product): 63323-221 Vancomycin Hydrochloride VANCOMYCIN HYDROCHLORIDE Fresenius Kabi, LLC 418c3c6a-d08d-448c-89c9-54e558c1ce16 2022-12-02 Warnings, Adverse reactions Exact identifier application applno (ANDA): 204107 application number: ANDA204107 ndc (product): 63323-221
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63323-221-01 63323022101 10 mL in 1 VIAL 10 ml Historical 63323-221-10 63323022110 25 VIAL in 1 TRAY (63323-221-10) / 10 mL in 1 VIAL (63323-221-01) 25 vial 2000-09-01 0000-00-00 No No Current 63323-221-16 63323022116 25 VIAL in 1 TRAY (63323-221-16) / 10 mL in 1 VIAL (63323-221-41) 25 vial 2021-05-03 0000-00-00 No No Current 63323-221-33 63323022133 10 mL in 1 VIAL 10 ml Historical 63323-221-38 63323022138 25 VIAL in 1 TRAY (63323-221-38) / 10 mL in 1 VIAL (63323-221-33) 25 vial 2017-11-01 0000-00-00 No No Current 63323-221-41 63323022141 10 mL in 1 VIAL 10 ml Historical 63323-221-43 63323022143 10 mL in 1 VIAL 10 ml Historical 63323-221-48 63323022148 25 VIAL in 1 TRAY (63323-221-48) / 10 mL in 1 VIAL (63323-221-43) 25 vial 2017-10-26 0000-00-00 No No Current