Home NDC 72572-105 Vancomycin Hydrochloride
Product NDC 72572-105
11-digit product format 725720105
Labeler code 72572
Product ID 72572-105_50e4fb19-f603-439c-b193-25a455115383
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name VANCOMYCIN HYDROCHLORIDE
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Civica, Inc
Application ANDA063076
Marketing category ANDA
Marketing start 2025-10-13
Substance VANCOMYCIN HYDROCHLORIDE
Active strength 500 mg/10mL
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A063076-001 VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP RS 1990-12-21 A063076-002 VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2020-09-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 2 · 80 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 A063076-001 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP RS 1990-12-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A063076-002 VANCOMYCIN HYDROCHLORIDE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2020-09-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A063076-001 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP RS 1990-12-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A063076-002 VANCOMYCIN HYDROCHLORIDE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2020-09-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A063076-001 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP RS 1990-12-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A063076-002 VANCOMYCIN HYDROCHLORIDE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2020-09-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A063076-001 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP RS 1990-12-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A063076-002 VANCOMYCIN HYDROCHLORIDE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2020-09-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A063076-001 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP RS 1990-12-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A063076-002 VANCOMYCIN HYDROCHLORIDE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2020-09-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A063076-001 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP RS 1990-12-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A063076-002 VANCOMYCIN HYDROCHLORIDE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2020-09-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A063076-001 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP RS 1990-12-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A063076-002 VANCOMYCIN HYDROCHLORIDE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2020-09-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A063076-001 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP RS 1990-12-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A063076-002 VANCOMYCIN HYDROCHLORIDE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2020-09-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A063076-001 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP RS 1990-12-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A063076-002 VANCOMYCIN HYDROCHLORIDE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2020-09-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A063076-001 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP RS 1990-12-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A063076-002 VANCOMYCIN HYDROCHLORIDE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2020-09-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A063076-001 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP RS 1990-12-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A063076-002 VANCOMYCIN HYDROCHLORIDE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2020-09-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A063076-001 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP RS 1990-12-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A063076-002 VANCOMYCIN HYDROCHLORIDE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2020-09-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A063076-001 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP RS 1990-12-21 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A063076-002 VANCOMYCIN HYDROCHLORIDE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2020-09-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A063076-001 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP RS 1990-12-21 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A063076-002 VANCOMYCIN HYDROCHLORIDE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2020-09-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A063076-001 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP RS 1990-12-21 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A063076-002 VANCOMYCIN HYDROCHLORIDE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2020-09-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A063076-001 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP RS 1990-12-21 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A063076-002 VANCOMYCIN HYDROCHLORIDE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2020-09-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A063076-001 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP RS 1990-12-21 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A063076-002 VANCOMYCIN HYDROCHLORIDE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2020-09-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A063076-001 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP RS 1990-12-21 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A063076-002 VANCOMYCIN HYDROCHLORIDE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2020-09-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A063076-001 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP RS 1990-12-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A063076-001 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP RS 1990-12-21 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A063076-002 VANCOMYCIN HYDROCHLORIDE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2020-09-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A063076-001 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP RS 1990-12-21 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 80 observed states.
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 500 mg/10mL
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 239209 Internal RxNorm lookup 313572 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 72572-105-01 Vancomycin Hydrochloride 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 1 72572-105-01 Vancomycin Hydrochloride 100 mL in 1 VIAL, PHARMACY BULK PACKAGE INJECTION, POWDER, LYOPHILIZED, 100 1
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 72572-105-01 72572010501 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (72572-105-01) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE 2025-10-13 No No Current