Home NDC 71288-023 Vancomycin Hydrochloride
Product NDC 71288-023
11-digit product format 712880023
Labeler code 71288
Product ID 71288-023_8783ba3b-c343-44ba-9a51-516751993478
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Vancomycin Hydrochloride
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Meitheal Pharmaceuticals Inc.
Application ANDA215197
Marketing category ANDA
Marketing start 2022-07-28
Substance VANCOMYCIN HYDROCHLORIDE
Active strength 1 g/20mL
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 42 .
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 A215197-001 VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2022-07-28 A215197-002 VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2022-07-28
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 · 56 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 2026-08-18 06:07:40 2026-07 A215197-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2022-07-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A215197-002 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2022-07-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A215197-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2022-07-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215197-002 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2022-07-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215197-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2022-07-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215197-002 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2022-07-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215197-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2022-07-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A215197-002 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2022-07-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215197-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2022-07-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215197-002 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2022-07-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215197-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2022-07-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215197-002 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2022-07-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215197-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2022-07-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215197-002 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2022-07-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215197-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2022-07-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215197-002 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2022-07-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215197-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2022-07-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215197-002 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2022-07-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215197-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2022-07-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215197-002 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2022-07-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215197-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2022-07-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A215197-002 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2022-07-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215197-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2022-07-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215197-002 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2022-07-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215197-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2022-07-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215197-002 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2022-07-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215197-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2022-07-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215197-002 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2022-07-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215197-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2022-07-28 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A215197-002 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2022-07-28 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215197-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2022-07-28 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215197-002 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2022-07-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215197-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2022-07-28 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A215197-002 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2022-07-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A215197-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2022-07-28 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A215197-002 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2022-07-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A215197-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2022-07-28 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A215197-002 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2022-07-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A215197-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2022-07-28 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A215197-002 VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2022-07-28 9b2671bbb829…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 56 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Vancomycin Hydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength VANCOMYCIN HYDROCHLORIDE 1 g/20mL
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1807513 Internal RxNorm lookup 1807516 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 71288-023-20 Vancomycin Hydrochloride 20 mL in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 20 5 71288-023-21 Vancomycin Hydrochloride 10 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 10 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71288-023 VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MEITHEAL PHARMACEUTICALS INC.] 5 Current NDC, Legacy NDC, 2 package rows 20231220_033efc76-11d5-4a93-91de-56ed41bab9c3.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 Marketing end Sample Exclude flag Status 71288-023-20 71288002320 20 mL in 1 VIAL, SINGLE-DOSE 20 ml Historical 71288-023-21 71288002321 10 VIAL, SINGLE-DOSE in 1 CARTON (71288-023-21) / 20 mL in 1 VIAL, SINGLE-DOSE (71288-023-20) 2022-07-28 0000-00-00 No No Current