Home NDC 67877-751-58 VANCOMYCIN HYDROCHLORIDE
Product NDC 67877-751
Requested package NDC 67877-751-58
11-digit product format 678770751
Labeler code 67877
Product ID 67877-751_fc015767-2010-4750-9eeb-b04fccdc8c7f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name VANCOMYCIN HYDROCHLORIDE
Dosage form KIT
Labeler Ascend Laboratories, LLC
Application ANDA214913
Marketing category ANDA
Marketing start 2023-08-01
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 A214913-001 VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 25MG BASE/ML FOR SOLUTION / ORAL AA 2022-11-14 A214913-002 VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 50MG BASE/ML FOR SOLUTION / ORAL AA 2022-11-14
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 2 · 52 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 A214913-001 VANCOMYCIN HYDROCHLORIDE EQ 25MG BASE/ML FOR SOLUTION / ORAL AA 2022-11-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 A214913-002 VANCOMYCIN HYDROCHLORIDE EQ 50MG BASE/ML FOR SOLUTION / ORAL AA 2022-11-14 84e616aacf4f…2026-08-18 06:07:40 2026-07 A214913-001 VANCOMYCIN HYDROCHLORIDE EQ 25MG BASE/ML FOR SOLUTION / ORAL AA 2022-11-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A214913-002 VANCOMYCIN HYDROCHLORIDE EQ 50MG BASE/ML FOR SOLUTION / ORAL AA 2022-11-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A214913-001 VANCOMYCIN HYDROCHLORIDE EQ 25MG BASE/ML FOR SOLUTION / ORAL AB 2022-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214913-002 VANCOMYCIN HYDROCHLORIDE EQ 50MG BASE/ML FOR SOLUTION / ORAL AB 2022-11-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214913-001 VANCOMYCIN HYDROCHLORIDE EQ 25MG BASE/ML FOR SOLUTION / ORAL AB 2022-11-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214913-002 VANCOMYCIN HYDROCHLORIDE EQ 50MG BASE/ML FOR SOLUTION / ORAL AB 2022-11-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214913-001 VANCOMYCIN HYDROCHLORIDE EQ 25MG BASE/ML FOR SOLUTION / ORAL AB 2022-11-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214913-002 VANCOMYCIN HYDROCHLORIDE EQ 50MG BASE/ML FOR SOLUTION / ORAL AB 2022-11-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214913-001 VANCOMYCIN HYDROCHLORIDE EQ 25MG BASE/ML FOR SOLUTION / ORAL AB 2022-11-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214913-002 VANCOMYCIN HYDROCHLORIDE EQ 50MG BASE/ML FOR SOLUTION / ORAL AB 2022-11-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214913-001 VANCOMYCIN HYDROCHLORIDE EQ 25MG BASE/ML FOR SOLUTION / ORAL AB 2022-11-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214913-002 VANCOMYCIN HYDROCHLORIDE EQ 50MG BASE/ML FOR SOLUTION / ORAL AB 2022-11-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214913-001 VANCOMYCIN HYDROCHLORIDE EQ 25MG BASE/ML FOR SOLUTION / ORAL AB 2022-11-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214913-002 VANCOMYCIN HYDROCHLORIDE EQ 50MG BASE/ML FOR SOLUTION / ORAL AB 2022-11-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214913-001 VANCOMYCIN HYDROCHLORIDE EQ 25MG BASE/ML FOR SOLUTION / ORAL AB 2022-11-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214913-002 VANCOMYCIN HYDROCHLORIDE EQ 50MG BASE/ML FOR SOLUTION / ORAL AB 2022-11-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214913-001 VANCOMYCIN HYDROCHLORIDE EQ 25MG BASE/ML FOR SOLUTION / ORAL AB 2022-11-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214913-002 VANCOMYCIN HYDROCHLORIDE EQ 50MG BASE/ML FOR SOLUTION / ORAL AB 2022-11-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214913-001 VANCOMYCIN HYDROCHLORIDE EQ 25MG BASE/ML FOR SOLUTION / ORAL AB 2022-11-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214913-002 VANCOMYCIN HYDROCHLORIDE EQ 50MG BASE/ML FOR SOLUTION / ORAL AB 2022-11-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214913-001 VANCOMYCIN HYDROCHLORIDE EQ 25MG BASE/ML FOR SOLUTION / ORAL AB 2022-11-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A214913-002 VANCOMYCIN HYDROCHLORIDE EQ 50MG BASE/ML FOR SOLUTION / ORAL AB 2022-11-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214913-001 VANCOMYCIN HYDROCHLORIDE EQ 25MG BASE/ML FOR SOLUTION / ORAL AB 2022-11-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214913-002 VANCOMYCIN HYDROCHLORIDE EQ 50MG BASE/ML FOR SOLUTION / ORAL AB 2022-11-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214913-001 VANCOMYCIN HYDROCHLORIDE EQ 25MG BASE/ML FOR SOLUTION / ORAL AB 2022-11-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214913-002 VANCOMYCIN HYDROCHLORIDE EQ 50MG BASE/ML FOR SOLUTION / ORAL AB 2022-11-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214913-001 VANCOMYCIN HYDROCHLORIDE EQ 25MG BASE/ML FOR SOLUTION / ORAL AB 2022-11-14 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214913-002 VANCOMYCIN HYDROCHLORIDE EQ 50MG BASE/ML FOR SOLUTION / ORAL AB 2022-11-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214913-001 VANCOMYCIN HYDROCHLORIDE EQ 25MG BASE/ML FOR SOLUTION / ORAL AB 2022-11-14 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A214913-002 VANCOMYCIN HYDROCHLORIDE EQ 50MG BASE/ML FOR SOLUTION / ORAL AB 2022-11-14 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214913-001 VANCOMYCIN HYDROCHLORIDE EQ 25MG BASE/ML FOR SOLUTION / ORAL AB 2022-11-14 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214913-002 VANCOMYCIN HYDROCHLORIDE EQ 50MG BASE/ML FOR SOLUTION / ORAL AB 2022-11-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A214913-001 VANCOMYCIN HYDROCHLORIDE EQ 25MG BASE/ML FOR SOLUTION / ORAL AB 2022-11-14 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A214913-002 VANCOMYCIN HYDROCHLORIDE EQ 50MG BASE/ML FOR SOLUTION / ORAL AB 2022-11-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A214913-001 VANCOMYCIN HYDROCHLORIDE EQ 25MG BASE/ML FOR SOLUTION / ORAL AB 2022-11-14 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A214913-002 VANCOMYCIN HYDROCHLORIDE EQ 50MG BASE/ML FOR SOLUTION / ORAL AB 2022-11-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A214913-001 VANCOMYCIN HYDROCHLORIDE EQ 25MG BASE/ML FOR SOLUTION / ORAL AB 2022-11-14 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A214913-002 VANCOMYCIN HYDROCHLORIDE EQ 50MG BASE/ML FOR SOLUTION / ORAL AB 2022-11-14 a72a2bbeb626…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 52 observed states.
Observed Orange Book exclusivity history# 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 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2000127 Internal RxNorm lookup 2000134 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 67877-751-58 VANCOMYCIN HYDROCHLORIDE 1 in 1 CARTON KIT 1 4 67877-751-81 VANCOMYCIN HYDROCHLORIDE 1 in 1 CARTON KIT 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67877-751 VANCOMYCIN HYDROCHLORIDE KIT [ASCEND LABORATORIES, LLC] 4 Current NDC, 2 package rows 20230801_b9a7c728-750b-467f-bf61-54dd836dba1b.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 · 1 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 67877-751-58 67877075158 1 KIT in 1 CARTON (67877-751-58) * 145 mL in 1 BOTTLE * 15 g in 1 BOTTLE * 289 mL in 1 BOTTLE * 7.5 g in 1 BOTTLE 1 kit 2023-08-01 No No Current