Home NDC 0409-6509 Vancomycin Hydrochloride
Product NDC 0409-6509
11-digit product format 004096509
Labeler code 0409
Product ID 0409-6509_39396834-5ba8-43a0-8ba2-719755e332b9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name VANCOMYCIN HYDROCHLORIDE
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Hospira, Inc.
Application ANDA063076
Marketing category ANDA
Marketing start 2005-06-06
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 1 .
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 · 78 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 2026-02-19 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…2021-12-28 21:50 UTC 2021-12 A063076-002 VANCOMYCIN HYDROCHLORIDE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2020-09-14 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A063076-001 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP RS 1990-12-21 87673890dc5c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 78 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 0409-6509-01 Vancomycin Hydrochloride 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 29 0409-6509-01 Vancomycin Hydrochloride 100 mL in 1 VIAL, PHARMACY BULK PACKAGE INJECTION, POWDER, LYOPHILIZED, 100 29 0409-6509-49 Vancomycin Hydrochloride 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 18 0409-6509-49 Vancomycin Hydrochloride 100 mL in 1 VIAL, PHARMACY BULK PACKAGE INJECTION, POWDER, LYOPHILIZED, 100 18
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded VANCOMYCIN HYDROCHLORIDE ACTIVE INGREDIENT 71WO621TJD VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.] 17 VANCOMYCIN ACTIVE MOIETY 6Q205EH1VU VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.] 17 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.] 17 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.] 17 VANCOMYCIN HYDROCHLORIDE ACTIVE INGREDIENT 71WO621TJD VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.] 1 VANCOMYCIN ACTIVE MOIETY 6Q205EH1VU VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.] 1 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0409-6509 VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.] 29 Current NDC, Legacy NDC, 2 package rows 20250119_91c050cf-3b2d-48bc-7297-e8dc68225e5a.zip 0409-6509 VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.] 18 Current NDC, Legacy NDC, 2 package rows 20250117_b01aaa02-8f1d-4b57-96a5-337503428af1.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 Marketing end Sample Exclude flag Status 0409-6509-01 00409650901 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (0409-6509-01) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE 2005-06-06 0000-00-00 No No Current 0409-6509-49 00409650949 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (0409-6509-49) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE 2019-01-15 0000-00-00 No No Current