Home NDC 76333-265-17 VANCOMYCIN HYDROCHLORIDE
Product NDC 76333-265
Requested package NDC 76333-265-17
11-digit product format 763330265
Labeler code 76333
Product ID 76333-265_e28461cb-fb8f-f468-e053-2a95a90ac294
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name VANCOMYCIN HYDROCHLORIDE
Dosage form CAPSULE
Route ORAL
Labeler Orient Pharma Co.,Ltd Yunlin Plant
Application ANDA210729
Marketing category ANDA
Marketing start 2019-07-25
Marketing end 0000-00-00
Substance VANCOMYCIN HYDROCHLORIDE
Active strength 250 mg/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 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 · 15 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…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
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 A210729-001 VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL AB 2019-04-29 A210729-002 VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL AB 2019-04-29
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 · 82 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 A210729-001 VANCOMYCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL AB 2019-04-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210729-002 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL AB 2019-04-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210729-001 VANCOMYCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL AB 2019-04-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210729-002 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL AB 2019-04-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210729-001 VANCOMYCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL AB 2019-04-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210729-002 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL AB 2019-04-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210729-001 VANCOMYCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL AB 2019-04-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210729-002 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL AB 2019-04-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210729-001 VANCOMYCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL AB 2019-04-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210729-002 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL AB 2019-04-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210729-001 VANCOMYCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL AB 2019-04-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210729-002 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL AB 2019-04-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210729-001 VANCOMYCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL AB 2019-04-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210729-002 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL AB 2019-04-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210729-001 VANCOMYCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL AB 2019-04-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210729-002 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL AB 2019-04-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210729-001 VANCOMYCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL AB 2019-04-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210729-002 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL AB 2019-04-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210729-001 VANCOMYCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL AB 2019-04-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A210729-002 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL AB 2019-04-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210729-001 VANCOMYCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL AB 2019-04-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210729-002 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL AB 2019-04-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210729-001 VANCOMYCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL AB 2019-04-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210729-002 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL AB 2019-04-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210729-001 VANCOMYCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL AB 2019-04-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210729-002 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL AB 2019-04-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210729-001 VANCOMYCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL AB 2019-04-29 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A210729-002 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL AB 2019-04-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210729-001 VANCOMYCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL AB 2019-04-29 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210729-002 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL AB 2019-04-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210729-001 VANCOMYCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL AB 2019-04-29 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A210729-002 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL AB 2019-04-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210729-001 VANCOMYCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL AB 2019-04-29 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A210729-002 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL AB 2019-04-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A210729-001 VANCOMYCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL AB 2019-04-29 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A210729-002 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL AB 2019-04-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A210729-001 VANCOMYCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL AB 2019-04-29 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A210729-002 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL AB 2019-04-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210729-001 VANCOMYCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL AB 2019-04-29 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A210729-002 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL AB 2019-04-29 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 76333-265-01 VANCOMYCIN HYDROCHLORIDE 2 in 1 CARTON CAPSULE 2 10 76333-265-17 VANCOMYCIN HYDROCHLORIDE 50 in 1 BOTTLE CAPSULE 50 10 76333-265-26 VANCOMYCIN HYDROCHLORIDE 10 in 1 BLISTER PACK CAPSULE 10 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76333-265 VANCOMYCIN HYDROCHLORIDE CAPSULE [ORIENT PHARMA CO.,LTD YUNLIN PLANT] 10 Legacy NDC, 3 package rows 20220630_6d7205eb-dd9f-4a43-91d8-4678293e7159.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 76333-265-17 76333026517 50 CAPSULE in 1 BOTTLE (76333-265-17) 50 capsule 2019-07-25 0000-00-00 No No Current