Home NDC 0143-9163 VANCOMYCIN HYDROCHLORIDE
Product NDC 0143-9163
11-digit product format 001439163
Labeler code 0143
Product ID 0143-9163_0e6d2908-b33a-4f3e-a283-e8e1a2d38e5f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name vancomycin hydrochloride
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAVENOUS; ORAL
Labeler HIKMA PHARMACEUTICALS USA INC.
Application NDA210274
Marketing category NDA
Marketing start 2023-02-03
Substance VANCOMYCIN HYDROCHLORIDE
Active strength 5.13 g/g
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 44 .
Orange Book products# Current product rows page 1 of 1 · 7 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N210274-001 VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS, ORAL RLD, RS 2023-01-20 N210274-002 VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL POWDER / INTRAVENOUS, ORAL RLD, RS 2023-01-20 N210274-003 VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL POWDER / INTRAVENOUS, ORAL RLD, RS 2023-01-20 N210274-004 VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 10GM BASE/VIAL POWDER / INTRAVENOUS, ORAL RLD, RS 2023-01-20 N210274-005 VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 750MG BASE/VIAL POWDER / INTRAVENOUS, ORAL RLD, RS 2025-08-01 N210274-006 VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 1.25GM BASE/VIAL POWDER / INTRAVENOUS, ORAL RLD, RS 2025-08-01 N210274-007 VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 1.5MG BASE/VIAL POWDER / INTRAVENOUS, ORAL RLD, RS 2025-08-01
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 · 122 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 2026-10-15 13:18:30 2026-09 N210274-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS, ORAL RLD, RS 2023-01-20 c2088c7a36db…2026-10-15 13:18:30 2026-09 N210274-002 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL POWDER / INTRAVENOUS, ORAL RLD, RS 2023-01-20 c2088c7a36db…2026-10-15 13:18:30 2026-09 N210274-003 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL POWDER / INTRAVENOUS, ORAL RLD, RS 2023-01-20 c2088c7a36db…2026-10-15 13:18:30 2026-09 N210274-004 VANCOMYCIN HYDROCHLORIDE EQ 10GM BASE/VIAL POWDER / INTRAVENOUS, ORAL RLD, RS 2023-01-20 c2088c7a36db…2026-10-15 13:18:30 2026-09 N210274-005 VANCOMYCIN HYDROCHLORIDE EQ 750MG BASE/VIAL POWDER / INTRAVENOUS, ORAL RLD, RS 2025-08-01 c2088c7a36db…2026-10-15 13:18:30 2026-09 N210274-006 VANCOMYCIN HYDROCHLORIDE EQ 1.25GM BASE/VIAL POWDER / INTRAVENOUS, ORAL RLD, RS 2025-08-01 c2088c7a36db…2026-10-15 13:18:30 2026-09 N210274-007 VANCOMYCIN HYDROCHLORIDE EQ 1.5MG BASE/VIAL POWDER / INTRAVENOUS, ORAL RLD, RS 2025-08-01 c2088c7a36db…2026-09-14 22:38:34 2026-08 N210274-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS, ORAL RLD, RS 2023-01-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N210274-002 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL POWDER / INTRAVENOUS, ORAL RLD, RS 2023-01-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N210274-003 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL POWDER / INTRAVENOUS, ORAL RLD, RS 2023-01-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N210274-004 VANCOMYCIN HYDROCHLORIDE EQ 10GM BASE/VIAL POWDER / INTRAVENOUS, ORAL RLD, RS 2023-01-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N210274-005 VANCOMYCIN HYDROCHLORIDE EQ 750MG BASE/VIAL POWDER / INTRAVENOUS, ORAL RLD, RS 2025-08-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 N210274-006 VANCOMYCIN HYDROCHLORIDE EQ 1.25GM BASE/VIAL POWDER / INTRAVENOUS, ORAL RLD, RS 2025-08-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 N210274-007 VANCOMYCIN HYDROCHLORIDE EQ 1.5MG BASE/VIAL POWDER / INTRAVENOUS, ORAL RLD, RS 2025-08-01 84e616aacf4f…2026-08-18 06:07:40 2026-07 N210274-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS, ORAL RLD, RS 2023-01-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210274-002 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL POWDER / INTRAVENOUS, ORAL RLD, RS 2023-01-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210274-003 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL POWDER / INTRAVENOUS, ORAL RLD, RS 2023-01-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210274-004 VANCOMYCIN HYDROCHLORIDE EQ 10GM BASE/VIAL POWDER / INTRAVENOUS, ORAL RLD, RS 2023-01-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210274-005 VANCOMYCIN HYDROCHLORIDE EQ 750MG BASE/VIAL POWDER / INTRAVENOUS, ORAL RLD, RS 2025-08-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210274-006 VANCOMYCIN HYDROCHLORIDE EQ 1.25GM BASE/VIAL POWDER / INTRAVENOUS, ORAL RLD, RS 2025-08-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210274-007 VANCOMYCIN HYDROCHLORIDE EQ 1.5MG BASE/VIAL POWDER / INTRAVENOUS, ORAL RLD, RS 2025-08-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N210274-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS, ORAL RLD, RS 2023-01-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210274-002 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL POWDER / INTRAVENOUS, ORAL RLD, RS 2023-01-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210274-003 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL POWDER / INTRAVENOUS, ORAL RLD, RS 2023-01-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210274-004 VANCOMYCIN HYDROCHLORIDE EQ 10GM BASE/VIAL POWDER / INTRAVENOUS, ORAL RLD, RS 2023-01-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210274-005 VANCOMYCIN HYDROCHLORIDE EQ 750MG BASE/VIAL POWDER / INTRAVENOUS, ORAL RLD, RS 2025-08-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210274-006 VANCOMYCIN HYDROCHLORIDE EQ 1.25GM BASE/VIAL POWDER / INTRAVENOUS, ORAL RLD, RS 2025-08-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210274-007 VANCOMYCIN HYDROCHLORIDE EQ 1.5MG BASE/VIAL POWDER / INTRAVENOUS, ORAL RLD, RS 2025-08-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210274-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS, ORAL RLD, RS 2023-01-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210274-002 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL POWDER / INTRAVENOUS, ORAL RLD, RS 2023-01-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210274-003 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL POWDER / INTRAVENOUS, ORAL RLD, RS 2023-01-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210274-004 VANCOMYCIN HYDROCHLORIDE EQ 10GM BASE/VIAL POWDER / INTRAVENOUS, ORAL RLD, RS 2023-01-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210274-005 VANCOMYCIN HYDROCHLORIDE EQ 750MG BASE/VIAL POWDER / INTRAVENOUS, ORAL RLD, RS 2025-08-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210274-006 VANCOMYCIN HYDROCHLORIDE EQ 1.25GM BASE/VIAL POWDER / INTRAVENOUS, ORAL RLD, RS 2025-08-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210274-007 VANCOMYCIN HYDROCHLORIDE EQ 1.5MG BASE/VIAL POWDER / INTRAVENOUS, ORAL RLD, RS 2025-08-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210274-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS, ORAL RLD, RS 2023-01-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210274-002 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL POWDER / INTRAVENOUS, ORAL RLD, RS 2023-01-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210274-003 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL POWDER / INTRAVENOUS, ORAL RLD, RS 2023-01-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210274-004 VANCOMYCIN HYDROCHLORIDE EQ 10GM BASE/VIAL POWDER / INTRAVENOUS, ORAL RLD, RS 2023-01-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210274-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS, ORAL RLD, RS 2023-01-20 fd3edfee7708…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 5.13 g/g
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 239209 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 0143-9163-01 VANCOMYCIN HYDROCHLORIDE 5.13 g in 1 VIAL, PHARMACY BULK PACKAGE INJECTION, POWDER, FOR SOLUTION 5.13 4 0143-9163-01 VANCOMYCIN HYDROCHLORIDE 1 in 1 CARTON INJECTION, POWDER, FOR SOLUTION 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0143-9163 VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.] 4 Current NDC, 2 package rows 20240810_e4ce7b87-fab4-4b7a-b121-eba136c464ce.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 0143-9163-01 00143916301 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (0143-9163-01) / 5.13 g in 1 VIAL, PHARMACY BULK PACKAGE 2023-02-03 No No Current