Home NDC 0409-6535-01 Vancomycin Hydrochloride
Product NDC 0409-6535
Requested package NDC 0409-6535-01
11-digit product format 004096535
Labeler code 0409
Product ID 0409-6535_3adba283-02f8-45a2-b191-873ca5b99364
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name VANCOMYCIN HYDROCHLORIDE
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Hospira, Inc.
Application ANDA062933
Marketing category ANDA
Marketing start 2005-04-30
Marketing end 0000-00-00
Substance VANCOMYCIN HYDROCHLORIDE
Active strength 1 g/1
Pharmacologic classes Glycopeptide Antibacterial [EPC], Glycopeptides [CS]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A062933-001 VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 1992-10-29 A062933-002 VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 750MG BASE/VIAL INJECTABLE / INJECTION AP 2009-05-27
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 3 · 86 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 2026-09-14 22:38:34 2026-08 A062933-001 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 1992-10-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 A062933-002 VANCOMYCIN HYDROCHLORIDE EQ 750MG BASE/VIAL INJECTABLE / INJECTION AP 2009-05-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 A062933-001 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 1992-10-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A062933-002 VANCOMYCIN HYDROCHLORIDE EQ 750MG BASE/VIAL INJECTABLE / INJECTION AP 2009-05-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A062933-001 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 1992-10-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A062933-002 VANCOMYCIN HYDROCHLORIDE EQ 750MG BASE/VIAL INJECTABLE / INJECTION AP 2009-05-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A062933-001 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 1992-10-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A062933-002 VANCOMYCIN HYDROCHLORIDE EQ 750MG BASE/VIAL INJECTABLE / INJECTION AP 2009-05-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A062933-001 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 1992-10-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A062933-002 VANCOMYCIN HYDROCHLORIDE EQ 750MG BASE/VIAL INJECTABLE / INJECTION AP 2009-05-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A062933-001 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 1992-10-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A062933-002 VANCOMYCIN HYDROCHLORIDE EQ 750MG BASE/VIAL INJECTABLE / INJECTION AP 2009-05-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A062933-001 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 1992-10-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A062933-002 VANCOMYCIN HYDROCHLORIDE EQ 750MG BASE/VIAL INJECTABLE / INJECTION AP 2009-05-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A062933-001 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 1992-10-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A062933-002 VANCOMYCIN HYDROCHLORIDE EQ 750MG BASE/VIAL INJECTABLE / INJECTION AP 2009-05-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A062933-001 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 1992-10-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A062933-002 VANCOMYCIN HYDROCHLORIDE EQ 750MG BASE/VIAL INJECTABLE / INJECTION AP 2009-05-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A062933-001 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 1992-10-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A062933-002 VANCOMYCIN HYDROCHLORIDE EQ 750MG BASE/VIAL INJECTABLE / INJECTION AP 2009-05-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A062933-001 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 1992-10-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A062933-002 VANCOMYCIN HYDROCHLORIDE EQ 750MG BASE/VIAL INJECTABLE / INJECTION AP 2009-05-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A062933-001 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 1992-10-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A062933-002 VANCOMYCIN HYDROCHLORIDE EQ 750MG BASE/VIAL INJECTABLE / INJECTION AP 2009-05-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A062933-001 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 1992-10-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A062933-002 VANCOMYCIN HYDROCHLORIDE EQ 750MG BASE/VIAL INJECTABLE / INJECTION AP 2009-05-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A062933-001 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 1992-10-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A062933-002 VANCOMYCIN HYDROCHLORIDE EQ 750MG BASE/VIAL INJECTABLE / INJECTION AP 2009-05-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A062933-001 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 1992-10-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A062933-002 VANCOMYCIN HYDROCHLORIDE EQ 750MG BASE/VIAL INJECTABLE / INJECTION AP 2009-05-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A062933-001 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 1992-10-29 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A062933-002 VANCOMYCIN HYDROCHLORIDE EQ 750MG BASE/VIAL INJECTABLE / INJECTION AP 2009-05-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A062933-001 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 1992-10-29 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A062933-002 VANCOMYCIN HYDROCHLORIDE EQ 750MG BASE/VIAL INJECTABLE / INJECTION AP RS 2009-05-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A062933-001 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 1992-10-29 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A062933-002 VANCOMYCIN HYDROCHLORIDE EQ 750MG BASE/VIAL INJECTABLE / INJECTION AP RS 2009-05-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A062933-001 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 1992-10-29 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A062933-002 VANCOMYCIN HYDROCHLORIDE EQ 750MG BASE/VIAL INJECTABLE / INJECTION AP RS 2009-05-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A062933-001 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 1992-10-29 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A062933-002 VANCOMYCIN HYDROCHLORIDE EQ 750MG BASE/VIAL INJECTABLE / INJECTION AP RS 2009-05-27 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0409-6535-01 Vancomycin Hydrochloride 10 in 1 TRAY INJECTION, POWDER, LYOPHILIZED, 10 35 0409-6535-11 Vancomycin Hydrochloride 1 in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 1 35
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.] 18 VANCOMYCIN ACTIVE MOIETY 6Q205EH1VU VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.] 18 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.] 18 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.] 18
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0409-6535 VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.] 34 Legacy NDC, 2 package rows 20250116_2fd9de3f-a95f-451c-a687-d2e1306e53bf.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0409-6535-01 00409653501 10 VIAL, SINGLE-DOSE in 1 TRAY (0409-6535-01) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (0409-6535-11) 2005-04-30 0000-00-00 No No Current