Home NDC 68083-597 Vancomycin Hydrochloride
Product NDC 68083-597
11-digit product format 680830597
Labeler code 68083
Product ID 68083-597_16f3240c-d1ce-4407-ad09-565915a13805
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Vancomycin Hydrochloride
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Gland Pharma Limited
Application ANDA218140
Marketing category ANDA
Marketing start 2025-03-21
Substance VANCOMYCIN HYDROCHLORIDE
Active strength 1.5 g/1
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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A218140-001 VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 750MG BASE/VIAL POWDER / INTRAVENOUS AP 2025-03-21 A218140-002 VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 1.25GM BASE/VIAL POWDER / INTRAVENOUS AP 2025-03-21 A218140-003 VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 1.5GM BASE/VIAL POWDER / INTRAVENOUS AP 2025-03-21
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.
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 A218140-001 VANCOMYCIN HYDROCHLORIDE EQ 750MG BASE/VIAL POWDER / INTRAVENOUS AP 2025-03-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A218140-002 VANCOMYCIN HYDROCHLORIDE EQ 1.25GM BASE/VIAL POWDER / INTRAVENOUS AP 2025-03-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A218140-003 VANCOMYCIN HYDROCHLORIDE EQ 1.5GM BASE/VIAL POWDER / INTRAVENOUS AP 2025-03-21 84e616aacf4f…2026-08-18 06:07:40 2026-07 A218140-001 VANCOMYCIN HYDROCHLORIDE EQ 750MG BASE/VIAL POWDER / INTRAVENOUS AP 2025-03-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218140-002 VANCOMYCIN HYDROCHLORIDE EQ 1.25GM BASE/VIAL POWDER / INTRAVENOUS AP 2025-03-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218140-003 VANCOMYCIN HYDROCHLORIDE EQ 1.5GM BASE/VIAL POWDER / INTRAVENOUS AP 2025-03-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A218140-001 VANCOMYCIN HYDROCHLORIDE EQ 750MG BASE/VIAL POWDER / INTRAVENOUS AP 2025-03-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218140-002 VANCOMYCIN HYDROCHLORIDE EQ 1.25GM BASE/VIAL POWDER / INTRAVENOUS AP 2025-03-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218140-003 VANCOMYCIN HYDROCHLORIDE EQ 1.5GM BASE/VIAL POWDER / INTRAVENOUS AP 2025-03-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218140-001 VANCOMYCIN HYDROCHLORIDE EQ 750MG BASE/VIAL POWDER / INTRAVENOUS AP 2025-03-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218140-002 VANCOMYCIN HYDROCHLORIDE EQ 1.25GM BASE/VIAL POWDER / INTRAVENOUS AP 2025-03-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218140-003 VANCOMYCIN HYDROCHLORIDE EQ 1.5GM BASE/VIAL POWDER / INTRAVENOUS AP 2025-03-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218140-001 VANCOMYCIN HYDROCHLORIDE EQ 750MG BASE/VIAL POWDER / INTRAVENOUS AP 2025-03-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218140-002 VANCOMYCIN HYDROCHLORIDE EQ 1.25GM BASE/VIAL POWDER / INTRAVENOUS AP 2025-03-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218140-003 VANCOMYCIN HYDROCHLORIDE EQ 1.5GM BASE/VIAL POWDER / INTRAVENOUS AP 2025-03-21 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218140-001 VANCOMYCIN HYDROCHLORIDE EQ 750MG BASE/VIAL POWDER / INTRAVENOUS AP 2025-03-21 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218140-002 VANCOMYCIN HYDROCHLORIDE EQ 1.25GM BASE/VIAL POWDER / INTRAVENOUS AP 2025-03-21 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218140-003 VANCOMYCIN HYDROCHLORIDE EQ 1.5GM BASE/VIAL POWDER / INTRAVENOUS AP 2025-03-21 a50c72e98297…
Observed Orange Book normalized TE history# 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 1.5 g/1
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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1807518 Internal RxNorm lookup 2049888 Internal RxNorm lookup 2049890 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 68083-597-01 Vancomycin Hydrochloride 1 in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 1 4 68083-597-10 Vancomycin Hydrochloride 10 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 10 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68083-597 VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GLAND PHARMA LIMITED] 4 Current NDC, 2 package rows 20250515_65e5f2ee-934c-40d7-967c-00d085f84ffd.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 68083-597-01 68083059701 1 in 1 VIAL, SINGLE-DOSE Historical 68083-597-10 68083059710 10 VIAL, SINGLE-DOSE in 1 CARTON (68083-597-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (68083-597-01) 2025-03-21 No No Current