Home NDC 0409-4332-01 Vancomycin Hydrochloride
Product NDC 0409-4332
Requested package NDC 0409-4332-01
11-digit product format 004094332
Labeler code 0409
Product ID 0409-4332_10032a19-0373-4c42-b785-f3d915614e30
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name VANCOMYCIN HYDROCHLORIDE
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Hospira, Inc.
Application ANDA062911
Marketing category ANDA
Marketing start 2005-04-30
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A062911-001 VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1988-08-04
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A062911-001 AP
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 · 44 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 A062911-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1988-08-04 c2088c7a36db…2026-09-14 22:38:34 2026-08 A062911-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1988-08-04 84e616aacf4f…2026-08-18 06:07:40 2026-07 A062911-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1988-08-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A062911-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1988-08-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A062911-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1988-08-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A062911-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1988-08-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A062911-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1988-08-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A062911-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1988-08-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A062911-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1988-08-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A062911-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1988-08-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A062911-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1988-08-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A062911-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1988-08-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A062911-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1988-08-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A062911-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1988-08-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A062911-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1988-08-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A062911-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1988-08-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A062911-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1988-08-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A062911-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1988-08-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A062911-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1988-08-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A062911-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1988-08-04 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A062911-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1988-08-04 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A062911-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1988-08-04 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A062911-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1988-08-04 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A062911-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1988-08-04 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A062911-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1988-08-04 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A062911-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1988-08-04 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A062911-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1988-08-04 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A062911-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1988-08-04 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A062911-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1988-08-04 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A062911-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1988-08-04 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A062911-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1988-08-04 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A062911-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1988-08-04 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A062911-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1988-08-04 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A062911-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1988-08-04 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A062911-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1988-08-04 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A062911-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1988-08-04 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A062911-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1988-08-04 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A062911-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1988-08-04 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A062911-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1988-08-04 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A062911-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1988-08-04 3a93d1ddd44b…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 44 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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1807513 Internal RxNorm lookup 1807516 Internal RxNorm lookup 1807518 Internal RxNorm lookup 2049890 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 0409-4332-01 Vancomycin Hydrochloride 10 in 1 TRAY INJECTION, POWDER, LYOPHILIZED, 10 37 0409-4332-11 Vancomycin Hydrochloride 1 in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 1 37 0409-4332-49 Vancomycin Hydrochloride 10 in 1 TRAY INJECTION, POWDER, LYOPHILIZED, 10 11 0409-4332-59 Vancomycin Hydrochloride 1 in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 1 11
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 STERILE VANCOMYCIN HYDROCHLORIDE (VANCOMYCIN HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GENERAL INJECTABLES & VACCINES, INC] 6 Vancomycin ACTIVE MOIETY 6Q205EH1VU STERILE VANCOMYCIN HYDROCHLORIDE (VANCOMYCIN HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GENERAL INJECTABLES & VACCINES, INC] 6 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 0409-4332 VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.] 36 Current NDC, Legacy NDC, 2 package rows 20250109_f2901045-904f-47bd-74a1-c561facd7f25.zip 0409-4332 VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.] 10 Current NDC, Legacy NDC, 2 package rows 20250117_c9ea31ec-4c26-452f-b07b-c5f894212cd5.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 Units Marketing start Marketing end Sample Exclude flag Status 0409-4332-01 00409433201 10 VIAL in 1 TRAY (0409-4332-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (0409-4332-11) 10 vial 2005-04-30 0000-00-00 No No Current