Home NDC 70594-122 Vancomycin Hydrochloride
Product NDC 70594-122
11-digit product format 705940122
Labeler code 70594
Product ID 70594-122_047a47f7-3fc4-4f77-aae1-a895c0f47e32
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name vancomycin hydrochloride
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Xellia Pharmaceuticals USA LLC
Application ANDA205694
Marketing category ANDA
Marketing start 2016-02-23
Substance VANCOMYCIN HYDROCHLORIDE
Active strength 500 mg/1
Pharmacologic classes Glycopeptide Antibacterial [EPC], Glycopeptides [CS]
NDC exclude flag No
Listing certified through 2027-12-31
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 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A205694-001 VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-01-21 A205694-002 VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2016-01-21 A205694-003 VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2023-06-06 A205694-004 VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2023-06-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 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 4 · 138 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 A205694-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-01-21 c2088c7a36db…2026-10-15 13:18:30 2026-09 A205694-002 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2016-01-21 c2088c7a36db…2026-10-15 13:18:30 2026-09 A205694-003 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2023-06-06 c2088c7a36db…2026-10-15 13:18:30 2026-09 A205694-004 VANCOMYCIN HYDROCHLORIDE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2023-06-06 c2088c7a36db…2026-09-14 22:38:34 2026-08 A205694-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-01-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A205694-002 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2016-01-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A205694-003 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2023-06-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A205694-004 VANCOMYCIN HYDROCHLORIDE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2023-06-06 84e616aacf4f…2026-08-18 06:07:40 2026-07 A205694-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-01-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205694-002 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2016-01-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205694-003 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2023-06-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205694-004 VANCOMYCIN HYDROCHLORIDE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2023-06-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A205694-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-01-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205694-002 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2016-01-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205694-003 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2023-06-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205694-004 VANCOMYCIN HYDROCHLORIDE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2023-06-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205694-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-01-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205694-002 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2016-01-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205694-003 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2023-06-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205694-004 VANCOMYCIN HYDROCHLORIDE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2023-06-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205694-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-01-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205694-002 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2016-01-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205694-003 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2023-06-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205694-004 VANCOMYCIN HYDROCHLORIDE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2023-06-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205694-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-01-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205694-002 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2016-01-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205694-003 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2023-06-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205694-004 VANCOMYCIN HYDROCHLORIDE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2023-06-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205694-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-01-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205694-002 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2016-01-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205694-003 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2023-06-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205694-004 VANCOMYCIN HYDROCHLORIDE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2023-06-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205694-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-01-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205694-002 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2016-01-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205694-003 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2023-06-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205694-004 VANCOMYCIN HYDROCHLORIDE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2023-06-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205694-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-01-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205694-002 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2016-01-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205694-003 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2023-06-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205694-004 VANCOMYCIN HYDROCHLORIDE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2023-06-06 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 138 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 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength VANCOMYCIN HYDROCHLORIDE 500 mg/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 · 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 70594-122-01 Vancomycin Hydrochloride 1 in 1 VIAL, GLASS INJECTION, POWDER, LYOPHILIZED, 1 1 70594-122-02 Vancomycin Hydrochloride 10 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 10 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70594-122 VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [XELLIA PHARMACEUTICALS USA LLC] 1 Current NDC, 2 package rows 20231214_8403695c-3614-490b-9797-6c5ebcdeef9b.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 70594-122-01 70594012201 1 in 1 VIAL, GLASS Historical 70594-122-02 70594012202 10 VIAL, GLASS in 1 CARTON (70594-122-02) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS (70594-122-01) 2023-10-29 No No Current