Home NDC 72078-065 Vancomycin Hydrochloride
Product NDC 72078-065
11-digit product format 720780065
Labeler code 72078
Product ID 72078-065_40a88420-5fcb-4715-abc5-595a18fd08d0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Vancomycin Hydrochloride
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Mylan Institutional LLC
Application NDA209481
Marketing category NDA
Marketing start 2024-07-23
Substance VANCOMYCIN HYDROCHLORIDE
Active strength 1.75 g/35mL
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 43 .
Orange Book products# Current product rows page 1 of 1 · 6 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N209481-001 VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** POWDER / INTRAVENOUS RLD 2018-07-10 N209481-002 VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 750MG BASE/VIAL POWDER / INTRAVENOUS AP RLD, RS 2018-07-10 N209481-003 VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 1.25GM BASE/VIAL POWDER / INTRAVENOUS AP RLD, RS 2018-07-10 N209481-004 VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 1.5GM BASE/VIAL POWDER / INTRAVENOUS AP RLD, RS 2018-07-10 N209481-005 VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 1.75GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2024-06-26 N209481-006 VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 2GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2024-06-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 5 · 200 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 2026-09-14 22:38:34 2026-08 N209481-001 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** POWDER / INTRAVENOUS RLD 2018-07-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209481-002 VANCOMYCIN HYDROCHLORIDE EQ 750MG BASE/VIAL POWDER / INTRAVENOUS AP RLD, RS 2018-07-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209481-003 VANCOMYCIN HYDROCHLORIDE EQ 1.25GM BASE/VIAL POWDER / INTRAVENOUS AP RLD, RS 2018-07-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209481-004 VANCOMYCIN HYDROCHLORIDE EQ 1.5GM BASE/VIAL POWDER / INTRAVENOUS AP RLD, RS 2018-07-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209481-005 VANCOMYCIN HYDROCHLORIDE EQ 1.75GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2024-06-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209481-006 VANCOMYCIN HYDROCHLORIDE EQ 2GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2024-06-26 84e616aacf4f…2026-08-18 06:07:40 2026-07 N209481-001 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** POWDER / INTRAVENOUS RLD 2018-07-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209481-002 VANCOMYCIN HYDROCHLORIDE EQ 750MG BASE/VIAL POWDER / INTRAVENOUS AP RLD, RS 2018-07-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209481-003 VANCOMYCIN HYDROCHLORIDE EQ 1.25GM BASE/VIAL POWDER / INTRAVENOUS AP RLD, RS 2018-07-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209481-004 VANCOMYCIN HYDROCHLORIDE EQ 1.5GM BASE/VIAL POWDER / INTRAVENOUS AP RLD, RS 2018-07-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209481-005 VANCOMYCIN HYDROCHLORIDE EQ 1.75GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2024-06-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209481-006 VANCOMYCIN HYDROCHLORIDE EQ 2GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2024-06-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N209481-001 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** POWDER / INTRAVENOUS RLD 2018-07-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209481-002 VANCOMYCIN HYDROCHLORIDE EQ 750MG BASE/VIAL POWDER / INTRAVENOUS AP RLD, RS 2018-07-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209481-003 VANCOMYCIN HYDROCHLORIDE EQ 1.25GM BASE/VIAL POWDER / INTRAVENOUS AP RLD, RS 2018-07-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209481-004 VANCOMYCIN HYDROCHLORIDE EQ 1.5GM BASE/VIAL POWDER / INTRAVENOUS AP RLD, RS 2018-07-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209481-005 VANCOMYCIN HYDROCHLORIDE EQ 1.75GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2024-06-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209481-006 VANCOMYCIN HYDROCHLORIDE EQ 2GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2024-06-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209481-001 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** POWDER / INTRAVENOUS RLD 2018-07-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209481-002 VANCOMYCIN HYDROCHLORIDE EQ 750MG BASE/VIAL POWDER / INTRAVENOUS AP RLD, RS 2018-07-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209481-003 VANCOMYCIN HYDROCHLORIDE EQ 1.25GM BASE/VIAL POWDER / INTRAVENOUS AP RLD, RS 2018-07-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209481-004 VANCOMYCIN HYDROCHLORIDE EQ 1.5GM BASE/VIAL POWDER / INTRAVENOUS AP RLD, RS 2018-07-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209481-005 VANCOMYCIN HYDROCHLORIDE EQ 1.75GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2024-06-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209481-006 VANCOMYCIN HYDROCHLORIDE EQ 2GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2024-06-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209481-001 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** POWDER / INTRAVENOUS RLD 2018-07-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209481-002 VANCOMYCIN HYDROCHLORIDE EQ 750MG BASE/VIAL POWDER / INTRAVENOUS AP RLD, RS 2018-07-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209481-003 VANCOMYCIN HYDROCHLORIDE EQ 1.25GM BASE/VIAL POWDER / INTRAVENOUS AP RLD, RS 2018-07-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209481-004 VANCOMYCIN HYDROCHLORIDE EQ 1.5GM BASE/VIAL POWDER / INTRAVENOUS AP RLD, RS 2018-07-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209481-005 VANCOMYCIN HYDROCHLORIDE EQ 1.75GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2024-06-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209481-006 VANCOMYCIN HYDROCHLORIDE EQ 2GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2024-06-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209481-001 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** POWDER / INTRAVENOUS RLD 2018-07-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209481-002 VANCOMYCIN HYDROCHLORIDE EQ 750MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2018-07-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209481-003 VANCOMYCIN HYDROCHLORIDE EQ 1.25GM BASE/VIAL POWDER / INTRAVENOUS AP RLD, RS 2018-07-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209481-004 VANCOMYCIN HYDROCHLORIDE EQ 1.5GM BASE/VIAL POWDER / INTRAVENOUS AP RLD, RS 2018-07-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209481-005 VANCOMYCIN HYDROCHLORIDE EQ 1.75GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2024-06-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209481-006 VANCOMYCIN HYDROCHLORIDE EQ 2GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2024-06-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209481-001 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** POWDER / INTRAVENOUS RLD 2018-07-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209481-002 VANCOMYCIN HYDROCHLORIDE EQ 750MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2018-07-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209481-003 VANCOMYCIN HYDROCHLORIDE EQ 1.25GM BASE/VIAL POWDER / INTRAVENOUS AP RLD, RS 2018-07-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209481-004 VANCOMYCIN HYDROCHLORIDE EQ 1.5GM BASE/VIAL POWDER / INTRAVENOUS AP RLD, RS 2018-07-10 b8a1b40f171c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 52 observed states.
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 1.75 g/35mL
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 2688632 Internal RxNorm lookup 2688634 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 72078-065-50 Vancomycin Hydrochloride 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 1 72078-065-50 Vancomycin Hydrochloride 50 mL in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 50 1 72078-065-99 Vancomycin Hydrochloride 10 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 10 1 72078-065-99 Vancomycin Hydrochloride 50 mL in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 50 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72078-065 VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MYLAN INSTITUTIONAL LLC] 1 Current NDC, 4 package rows 20240725_40a88420-5fcb-4715-abc5-595a18fd08d0.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 · 2 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 72078-065-50 72078006550 1 in 1 CARTON Historical 72078-065-99 72078006599 10 VIAL, SINGLE-DOSE in 1 CARTON (72078-065-99) / 50 mL in 1 VIAL, SINGLE-DOSE 2024-07-23 No No Current