Home NDC 70594-042 Vancomycin
Product NDC 70594-042
11-digit product format 705940042
Labeler code 70594
Product ID 70594-042_e49b6589-caca-4c8f-8c57-55a1ee7774cc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Vancomycin
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Xellia Pharmaceuticals USA LLC
Application NDA211962
Marketing category NDA
Marketing start 2019-02-15
Substance VANCOMYCIN
Active strength 1 g/200mL
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 · 7 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N211962-001 TYZAVAN VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/100ML (EQ 5MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-02-15 N211962-002 TYZAVAN VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/200ML (EQ 5MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-02-15 N211962-003 TYZAVAN VANCOMYCIN HYDROCHLORIDE EQ 1.5GM BASE/300ML (EQ 5MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-02-15 N211962-004 TYZAVAN VANCOMYCIN HYDROCHLORIDE EQ 2GM BASE/400ML (EQ 5MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-02-15 N211962-005 TYZAVAN VANCOMYCIN HYDROCHLORIDE EQ 750MG BASE/150ML (EQ 5MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-13 N211962-006 TYZAVAN VANCOMYCIN HYDROCHLORIDE EQ 1.25GM BASE/250ML (EQ 5MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-13 N211962-007 TYZAVAN VANCOMYCIN HYDROCHLORIDE EQ 1.75GM BASE/350ML (EQ 5MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-13
Orange Book patents# Current patent rows page 1 of 1 · 42 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 8 · 282 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 N211962-001 TYZAVAN EQ 500MG BASE/100ML (EQ 5MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-02-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211962-002 TYZAVAN EQ 1GM BASE/200ML (EQ 5MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-02-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211962-003 TYZAVAN EQ 1.5GM BASE/300ML (EQ 5MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-02-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211962-004 TYZAVAN EQ 2GM BASE/400ML (EQ 5MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-02-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211962-005 TYZAVAN EQ 750MG BASE/150ML (EQ 5MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211962-006 TYZAVAN EQ 1.25GM BASE/250ML (EQ 5MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211962-007 TYZAVAN EQ 1.75GM BASE/350ML (EQ 5MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N211962-001 TYZAVAN EQ 500MG BASE/100ML (EQ 5MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-02-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211962-002 TYZAVAN EQ 1GM BASE/200ML (EQ 5MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-02-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211962-003 TYZAVAN EQ 1.5GM BASE/300ML (EQ 5MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-02-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211962-004 TYZAVAN EQ 2GM BASE/400ML (EQ 5MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-02-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211962-005 TYZAVAN EQ 750MG BASE/150ML (EQ 5MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211962-006 TYZAVAN EQ 1.25GM BASE/250ML (EQ 5MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211962-007 TYZAVAN EQ 1.75GM BASE/350ML (EQ 5MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211962-001 TYZAVAN EQ 500MG BASE/100ML (EQ 5MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-02-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211962-002 TYZAVAN EQ 1GM BASE/200ML (EQ 5MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-02-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211962-003 TYZAVAN EQ 1.5GM BASE/300ML (EQ 5MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-02-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211962-004 TYZAVAN EQ 2GM BASE/400ML (EQ 5MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-02-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211962-005 TYZAVAN EQ 750MG BASE/150ML (EQ 5MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211962-006 TYZAVAN EQ 1.25GM BASE/250ML (EQ 5MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211962-007 TYZAVAN EQ 1.75GM BASE/350ML (EQ 5MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N211962-001 TYZAVAN EQ 500MG BASE/100ML (EQ 5MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-02-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211962-002 TYZAVAN EQ 1GM BASE/200ML (EQ 5MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-02-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211962-003 TYZAVAN EQ 1.5GM BASE/300ML (EQ 5MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-02-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211962-004 TYZAVAN EQ 2GM BASE/400ML (EQ 5MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-02-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211962-005 TYZAVAN EQ 750MG BASE/150ML (EQ 5MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211962-006 TYZAVAN EQ 1.25GM BASE/250ML (EQ 5MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211962-007 TYZAVAN EQ 1.75GM BASE/350ML (EQ 5MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211962-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/100ML (EQ 5MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-02-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211962-002 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/200ML (EQ 5MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-02-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211962-003 VANCOMYCIN HYDROCHLORIDE EQ 1.5GM BASE/300ML (EQ 5MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-02-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211962-004 VANCOMYCIN HYDROCHLORIDE EQ 2GM BASE/400ML (EQ 5MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-02-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211962-005 VANCOMYCIN HYDROCHLORIDE EQ 750MG BASE/150ML (EQ 5MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211962-006 VANCOMYCIN HYDROCHLORIDE EQ 1.25GM BASE/250ML (EQ 5MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211962-007 VANCOMYCIN HYDROCHLORIDE EQ 1.75GM BASE/350ML (EQ 5MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211962-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/100ML (EQ 5MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-02-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211962-002 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/200ML (EQ 5MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-02-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211962-003 VANCOMYCIN HYDROCHLORIDE EQ 1.5GM BASE/300ML (EQ 5MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-02-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211962-004 VANCOMYCIN HYDROCHLORIDE EQ 2GM BASE/400ML (EQ 5MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-02-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211962-005 VANCOMYCIN HYDROCHLORIDE EQ 750MG BASE/150ML (EQ 5MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-13 b8a1b40f171c…
Observed Orange Book patent history# Patent history page 1 of 31 · 1,201 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N211962-001 10039804 2035-11-06 U-282 Drug product 2019-03-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211962-001 10188697 2035-11-06 U-282 Drug product 2019-03-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211962-001 10849956 2035-11-06 Drug product 2020-12-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211962-001 11517609 2035-11-06 U-282 2022-12-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211962-001 11628200 2035-11-06 Drug product 2023-05-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211962-001 12161690 2035-11-06 Drug product 2025-01-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211962-002 10039804 2035-11-06 U-282 Drug product 2019-03-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211962-002 10188697 2035-11-06 U-282 Drug product 2019-03-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211962-002 10849956 2035-11-06 Drug product 2020-12-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211962-002 11517609 2035-11-06 U-282 2022-12-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211962-002 11628200 2035-11-06 Drug product 2023-05-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211962-002 12161690 2035-11-06 Drug product 2025-01-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211962-003 10039804 2035-11-06 U-282 Drug product 2019-03-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211962-003 10188697 2035-11-06 U-282 Drug product 2019-03-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211962-003 10849956 2035-11-06 Drug product 2020-12-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211962-003 11517609 2035-11-06 U-282 2022-12-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211962-003 11628200 2035-11-06 Drug product 2023-05-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211962-003 12161690 2035-11-06 Drug product 2025-01-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211962-004 10039804 2035-11-06 U-282 Drug product 2019-03-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211962-004 10188697 2035-11-06 U-282 Drug product 2019-03-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211962-004 10849956 2035-11-06 Drug product 2020-12-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211962-004 11517609 2035-11-06 U-282 2022-12-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211962-004 11628200 2035-11-06 Drug product 2023-05-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211962-004 12161690 2035-11-06 Drug product 2025-01-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211962-005 10039804 2035-11-06 U-282 Drug product 2020-05-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211962-005 10188697 2035-11-06 U-282 Drug product 2020-05-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211962-005 10849956 2035-11-06 Drug product 2020-12-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211962-005 11517609 2035-11-06 U-282 2022-12-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211962-005 11628200 2035-11-06 Drug product 2023-05-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211962-005 12161690 2035-11-06 Drug product 2025-01-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211962-006 10039804 2035-11-06 U-282 Drug product 2020-05-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211962-006 10188697 2035-11-06 U-282 Drug product 2020-05-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211962-006 10849956 2035-11-06 Drug product 2020-12-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211962-006 11517609 2035-11-06 U-282 2022-12-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211962-006 11628200 2035-11-06 Drug product 2023-05-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211962-006 12161690 2035-11-06 Drug product 2025-01-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211962-007 10039804 2035-11-06 U-282 Drug product 2020-05-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211962-007 10188697 2035-11-06 U-282 Drug product 2020-05-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211962-007 10849956 2035-11-06 Drug product 2020-12-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211962-007 11517609 2035-11-06 U-282 2022-12-15 caaa826d4ba7…
Additional Listing Data#
Finished product Yes
Brand name base Vancomycin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength VANCOMYCIN 1 g/200mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 6Q205EH1VU Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 7 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1807508 Internal RxNorm lookup 1807510 Internal RxNorm lookup 1807511 Internal RxNorm lookup 2118448 Internal RxNorm lookup 2118449 Internal RxNorm lookup 2387078 Internal RxNorm lookup 2387079 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 70594-042-01 Vancomycin 200 mL in 1 BAG INJECTION, SOLUTION 200 17 70594-042-02 Vancomycin 6 in 1 CARTON INJECTION, SOLUTION 6 17 70594-042-03 Vancomycin 12 in 1 CARTON INJECTION, SOLUTION 12 17
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70594-042 VANCOMYCIN INJECTION, SOLUTION [XELLIA PHARMACEUTICALS USA LLC] 17 Current NDC, Legacy NDC, 3 package rows 20230331_60bee69b-be70-412c-9e83-a24a0a8a5e7b.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 Units Marketing start Marketing end Sample Exclude flag Status 70594-042-01 70594004201 200 mL in 1 BAG 200 ml Historical 70594-042-02 70594004202 6 BAG in 1 CARTON (70594-042-02) / 200 mL in 1 BAG (70594-042-01) 6 bag 2019-02-15 0000-00-00 No No Current 70594-042-03 70594004203 12 BAG in 1 CARTON (70594-042-03) / 200 mL in 1 BAG (70594-042-01) 12 bag 2019-02-15 0000-00-00 No No Current