Home NDC 67457-613-10 Vancomycin Hydrochloride
Product NDC 67457-613
Requested package NDC 67457-613-10
11-digit product format 674570613
Labeler code 67457
Product ID 67457-613_142d60ec-f7c0-4dbf-8802-6820966f3a9b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Vancomycin Hydrochloride
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Mylan Institutional LLC
Application ANDA065432
Marketing category ANDA
Marketing start 2008-12-31
Marketing end 0000-00-00
Substance VANCOMYCIN HYDROCHLORIDE
Active strength 5 g/100mL
Pharmacologic classes Glycopeptide Antibacterial [EPC],Glycopeptides [CS]
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A065432-001 VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2008-12-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A065432-001 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 · 43 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 A065432-001 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2008-12-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 A065432-001 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2008-12-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065432-001 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2008-12-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065432-001 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2008-12-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065432-001 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2008-12-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065432-001 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2008-12-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065432-001 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2008-12-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065432-001 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2008-12-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065432-001 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2008-12-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065432-001 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2008-12-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065432-001 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2008-12-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065432-001 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2008-12-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065432-001 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2008-12-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065432-001 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2008-12-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065432-001 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2008-12-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065432-001 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2008-12-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065432-001 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2008-12-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065432-001 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2008-12-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065432-001 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2008-12-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065432-001 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2008-12-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065432-001 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2008-12-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065432-001 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2008-12-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A065432-001 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2008-12-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A065432-001 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2008-12-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A065432-001 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2008-12-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A065432-001 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2008-12-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A065432-001 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2008-12-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A065432-001 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2008-12-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A065432-001 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2008-12-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A065432-001 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2008-12-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A065432-001 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2008-12-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A065432-001 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2008-12-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A065432-001 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2008-12-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A065432-001 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2008-12-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A065432-001 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2008-12-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A065432-001 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2008-12-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A065432-001 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2008-12-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A065432-001 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2008-12-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A065432-001 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2008-12-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A065432-001 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2008-12-30 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 [MYLAN INSTITUTIONAL LLC] 1 VANCOMYCIN ACTIVE MOIETY 6Q205EH1VU VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MYLAN INSTITUTIONAL LLC] 1 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MYLAN INSTITUTIONAL LLC] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MYLAN INSTITUTIONAL LLC] 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 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 67457-613-10 67457061310 1 VIAL in 1 CARTON (67457-613-10) > 100 mL in 1 VIAL 1 vial 2008-12-31 0000-00-00 No No Current