Home NDC 72572-029 Vancomycin Hydrochloride
Product NDC 72572-029
11-digit product format 725720029
Labeler code 72572
Product ID 72572-029_a5c53da8-668f-4b69-a672-86fcc8e02bfb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name VANCOMYCIN HYDROCHLORIDE
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Civica, Inc
Application ANDA062912
Marketing category ANDA
Marketing start 2025-11-10
Substance VANCOMYCIN HYDROCHLORIDE
Active strength 1 g/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 42 .
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 A062912-001 VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 1988-08-04 A062912-002 VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 750MG BASE/VIAL INJECTABLE / INJECTION AP 2009-01-07 A062912-003 VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION RS 2020-07-10
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 4 · 122 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 A062912-001 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 1988-08-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A062912-002 VANCOMYCIN HYDROCHLORIDE EQ 750MG BASE/VIAL INJECTABLE / INJECTION AP 2009-01-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A062912-003 VANCOMYCIN HYDROCHLORIDE EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION RS 2020-07-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A062912-001 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 1988-08-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A062912-002 VANCOMYCIN HYDROCHLORIDE EQ 750MG BASE/VIAL INJECTABLE / INJECTION AP 2009-01-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A062912-003 VANCOMYCIN HYDROCHLORIDE EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION RS 2020-07-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A062912-001 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 1988-08-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A062912-002 VANCOMYCIN HYDROCHLORIDE EQ 750MG BASE/VIAL INJECTABLE / INJECTION AP 2009-01-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A062912-003 VANCOMYCIN HYDROCHLORIDE EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION RS 2020-07-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A062912-001 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 1988-08-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A062912-002 VANCOMYCIN HYDROCHLORIDE EQ 750MG BASE/VIAL INJECTABLE / INJECTION AP 2009-01-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A062912-003 VANCOMYCIN HYDROCHLORIDE EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION RS 2020-07-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A062912-001 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 1988-08-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A062912-002 VANCOMYCIN HYDROCHLORIDE EQ 750MG BASE/VIAL INJECTABLE / INJECTION AP 2009-01-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A062912-003 VANCOMYCIN HYDROCHLORIDE EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION RS 2020-07-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A062912-001 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 1988-08-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A062912-002 VANCOMYCIN HYDROCHLORIDE EQ 750MG BASE/VIAL INJECTABLE / INJECTION AP 2009-01-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A062912-003 VANCOMYCIN HYDROCHLORIDE EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION RS 2020-07-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A062912-001 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 1988-08-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A062912-002 VANCOMYCIN HYDROCHLORIDE EQ 750MG BASE/VIAL INJECTABLE / INJECTION AP 2009-01-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A062912-003 VANCOMYCIN HYDROCHLORIDE EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION RS 2020-07-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A062912-001 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 1988-08-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A062912-002 VANCOMYCIN HYDROCHLORIDE EQ 750MG BASE/VIAL INJECTABLE / INJECTION AP 2009-01-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A062912-003 VANCOMYCIN HYDROCHLORIDE EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION RS 2020-07-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A062912-001 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 1988-08-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A062912-002 VANCOMYCIN HYDROCHLORIDE EQ 750MG BASE/VIAL INJECTABLE / INJECTION AP 2009-01-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A062912-003 VANCOMYCIN HYDROCHLORIDE EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION RS 2020-07-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A062912-001 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 1988-08-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A062912-002 VANCOMYCIN HYDROCHLORIDE EQ 750MG BASE/VIAL INJECTABLE / INJECTION AP 2009-01-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A062912-003 VANCOMYCIN HYDROCHLORIDE EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION RS 2020-07-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A062912-001 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 1988-08-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A062912-002 VANCOMYCIN HYDROCHLORIDE EQ 750MG BASE/VIAL INJECTABLE / INJECTION AP 2009-01-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A062912-003 VANCOMYCIN HYDROCHLORIDE EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION RS 2020-07-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A062912-001 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 1988-08-04 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A062912-002 VANCOMYCIN HYDROCHLORIDE EQ 750MG BASE/VIAL INJECTABLE / INJECTION AP 2009-01-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A062912-003 VANCOMYCIN HYDROCHLORIDE EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION RS 2020-07-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A062912-001 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 1988-08-04 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A062912-002 VANCOMYCIN HYDROCHLORIDE EQ 750MG BASE/VIAL INJECTABLE / INJECTION AP 2009-01-07 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A062912-003 VANCOMYCIN HYDROCHLORIDE EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION RS 2020-07-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A062912-001 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 1988-08-04 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
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 1 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1807513 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 72572-029-01 Vancomycin Hydrochloride 1 in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 1 2 72572-029-10 Vancomycin Hydrochloride 10 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 10 2
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 72572-029-01 72572002901 1 in 1 VIAL, SINGLE-DOSE Historical 72572-029-10 72572002910 10 VIAL, SINGLE-DOSE in 1 CARTON (72572-029-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72572-029-01) 2025-11-10 No No Current