Home NDC 80425-0514-6 vancomycin hydrochloride
Product NDC 80425-0514
Requested package NDC 80425-0514-6
11-digit product format 804250514
Labeler code 80425
Product ID 80425-0514_331277b8-8300-d082-e063-6394a90a4dd3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name vancomycin hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Advanced Rx of Tennessee, LLC
Application NDA050606
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2025-04-18
Substance VANCOMYCIN HYDROCHLORIDE
Active strength 250 mg/1
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 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 N050606-001 VANCOCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL AB RLD 1986-04-15 N050606-002 VANCOCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL AB RLD, RS 1986-04-15
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 N050606-001 VANCOCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL AB RLD 1986-04-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 N050606-002 VANCOCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL AB RLD, RS 1986-04-15 84e616aacf4f…2026-08-18 06:07:40 2026-07 N050606-001 VANCOCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL AB RLD 1986-04-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N050606-002 VANCOCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL AB RLD, RS 1986-04-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N050606-001 VANCOCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL AB RLD 1986-04-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N050606-002 VANCOCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL AB RLD, RS 1986-04-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050606-001 VANCOCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL AB RLD 1986-04-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050606-002 VANCOCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL AB RLD, RS 1986-04-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N050606-001 VANCOCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL AB RLD 1986-04-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N050606-002 VANCOCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL AB RLD, RS 1986-04-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050606-001 VANCOCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL AB RLD 1986-04-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050606-002 VANCOCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL AB RLD, RS 1986-04-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050606-001 VANCOCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL AB RLD 1986-04-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050606-002 VANCOCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL AB RLD, RS 1986-04-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050606-001 VANCOCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL AB RLD 1986-04-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050606-002 VANCOCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL AB RLD, RS 1986-04-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050606-001 VANCOCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL AB RLD 1986-04-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050606-002 VANCOCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL AB RLD, RS 1986-04-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050606-001 VANCOCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL AB RLD 1986-04-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050606-002 VANCOCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL AB RLD, RS 1986-04-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050606-001 VANCOCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL AB RLD 1986-04-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050606-002 VANCOCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL AB RLD, RS 1986-04-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N050606-001 VANCOCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL AB RLD 1986-04-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N050606-002 VANCOCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL AB RLD, RS 1986-04-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050606-001 VANCOCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL AB RLD 1986-04-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050606-002 VANCOCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL AB RLD, RS 1986-04-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050606-001 VANCOCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL AB RLD 1986-04-15 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050606-002 VANCOCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL AB RLD, RS 1986-04-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050606-001 VANCOCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL AB RLD 1986-04-15 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050606-002 VANCOCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL AB RLD, RS 1986-04-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N050606-001 VANCOCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL AB RLD 1986-04-15 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N050606-002 VANCOCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL AB RLD, RS 1986-04-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050606-001 VANCOCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL AB RLD 1986-04-15 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050606-002 VANCOCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL AB RLD, RS 1986-04-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N050606-001 VANCOCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL AB RLD 1986-04-15 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N050606-002 VANCOCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL AB RLD, RS 1986-04-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N050606-001 VANCOCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL AB RLD 1986-04-15 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N050606-002 VANCOCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL AB RLD, RS 1986-04-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N050606-001 VANCOCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL AB RLD 1986-04-15 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N050606-002 VANCOCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL AB RLD, RS 1986-04-15 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.
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 250 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 313571 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 80425-0514-1 vancomycin hydrochloride 20 in 1 BOTTLE CAPSULE 20 1 80425-0514-2 vancomycin hydrochloride 30 in 1 BOTTLE CAPSULE 30 1 80425-0514-3 vancomycin hydrochloride 60 in 1 BOTTLE CAPSULE 60 1 80425-0514-4 vancomycin hydrochloride 90 in 1 BOTTLE CAPSULE 90 1 80425-0514-5 vancomycin hydrochloride 40 in 1 BOTTLE CAPSULE 40 1 80425-0514-6 vancomycin hydrochloride 50 in 1 BOTTLE CAPSULE 50 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80425-0514 VANCOMYCIN HYDROCHLORIDE CAPSULE [ADVANCED RX OF TENNESSEE, LLC] 1 Current NDC, 6 package rows 20250420_33127951-1fad-15c1-e063-6294a90a6996.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 · 4 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 80425-0514-6 80425051406 50 CAPSULE in 1 BOTTLE (80425-0514-6) 50 capsule 2025-04-18 No No Current