Home NDC 63323-284 Vancomycin Hydrochloride
Product NDC 63323-284
11-digit product format 633230284
Labeler code 63323
Product ID 63323-284_23a89459-d331-4975-84fe-4bfa6ed2c24e
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 2017-10-26
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 42 .
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 · 84 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 2026-08-18 06:07:40 2026-07 A204107-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-12-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204107-002 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2015-12-28 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 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 1 g/20mL
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1807513 Internal RxNorm lookup 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 63323-284-01 VANCOMYCIN HYDROCHLORIDE 20 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 20 17 63323-284-20 VANCOMYCIN HYDROCHLORIDE 10 in 1 TRAY INJECTION, POWDER, LYOPHILIZED, 10 17 63323-284-26 VANCOMYCIN HYDROCHLORIDE 10 in 1 TRAY INJECTION, POWDER, LYOPHILIZED, 10 8 63323-284-42 VANCOMYCIN HYDROCHLORIDE 20 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 20 8 63323-284-41 Vancomycin Hydrochloride 20 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 20 5 63323-284-45 Vancomycin Hydrochloride 10 in 1 TRAY INJECTION, POWDER, LYOPHILIZED, 10 5 63323-284-21 VANCOMYCIN HYDROCHLORIDE 10 in 1 TRAY INJECTION, POWDER, LYOPHILIZED, 10 3 63323-284-21 VANCOMYCIN HYDROCHLORIDE 20 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 20 3
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 63323-284 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 63323-284 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 63323-284 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 63323-284 VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 3 Current NDC, Legacy NDC, 2 package rows 20241019_83ea3faf-fedd-4725-911f-d71a23ec5d5e.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 · 5 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): 63323-284 VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE Fresenius Kabi USA, LLC 83ea3faf-fedd-4725-911f-d71a23ec5d5e 2024-10-15 Warnings, Adverse reactions Exact identifier ndc (product): 63323-284 VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE Fresenius Kabi USA, LLC 0576803d-95de-4a48-806a-69ae3fcaf6b0 2023-08-17 Warnings, Adverse reactions Exact identifier ndc (product): 63323-284 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 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): 63323-284
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 63323-284-01 63323028401 20 mL in 1 VIAL 20 ml Historical 63323-284-20 63323028420 10 VIAL in 1 TRAY (63323-284-20) / 20 mL in 1 VIAL (63323-284-01) 10 vial 2000-09-20 0000-00-00 No No Current 63323-284-21 63323028421 10 VIAL in 1 TRAY (63323-284-21) / 20 mL in 1 VIAL 10 vial 2000-09-20 0000-00-00 No No Current 63323-284-26 63323028426 10 VIAL in 1 TRAY (63323-284-26) / 20 mL in 1 VIAL (63323-284-42) 10 vial 2021-05-03 0000-00-00 No No Current 63323-284-41 63323028441 20 mL in 1 VIAL 20 ml Historical 63323-284-42 63323028442 20 mL in 1 VIAL 20 ml Historical 63323-284-45 63323028445 10 VIAL in 1 TRAY (63323-284-45) / 20 mL in 1 VIAL (63323-284-41) 10 vial 2017-10-26 0000-00-00 No No Current