Home NDC 62559-391 vancomycin hydrochloride
Product NDC 62559-391
11-digit product format 625590391
Labeler code 62559
Product ID 62559-391_cf20df7a-8689-49f9-a77b-a0a832fea8fa
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name vancomycin hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler ANI Pharmaceuticals, Inc.
Application NDA050606
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2015-10-26
Substance VANCOMYCIN HYDROCHLORIDE
Active strength 250 mg/1
Pharmacologic classes Glycopeptide Antibacterial [EPC], Glycopeptides [CS]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 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 · 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 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…2022-03-09 01:35 UTC 2022-03 N050606-001 VANCOCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL AB RLD 1986-04-15 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N050606-002 VANCOCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL AB RLD, RS 1986-04-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N050606-001 VANCOCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL AB RLD 1986-04-15 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N050606-002 VANCOCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL AB RLD, RS 1986-04-15 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 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 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 313570 Internal RxNorm lookup 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 62559-391-20 vancomycin hydrochloride 10 in 1 BLISTER PACK CAPSULE 10 11 62559-391-20 vancomycin hydrochloride 2 in 1 CARTON CAPSULE 2 11 62559-391-50 vancomycin hydrochloride 50 in 1 BOTTLE CAPSULE 50 11
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded vancomycin hydrochloride ACTIVE INGREDIENT 71WO621TJD VANCOMYCIN HYDROCHLORIDE CAPSULE [ANI PHARMACEUTICALS, INC.] 1 vancomycin ACTIVE MOIETY 6Q205EH1VU VANCOMYCIN HYDROCHLORIDE CAPSULE [ANI PHARMACEUTICALS, INC.] 1 FD&C Blue NO. 2 INACTIVE INGREDIENT L06K8R7DQK VANCOMYCIN HYDROCHLORIDE CAPSULE [ANI PHARMACEUTICALS, INC.] 1 Ferric Oxide Red INACTIVE INGREDIENT 1K09F3G675 VANCOMYCIN HYDROCHLORIDE CAPSULE [ANI PHARMACEUTICALS, INC.] 1 Ferric Oxide Yellow INACTIVE INGREDIENT EX438O2MRT VANCOMYCIN HYDROCHLORIDE CAPSULE [ANI PHARMACEUTICALS, INC.] 1 Ferrosoferric Oxide INACTIVE INGREDIENT XM0M87F357 VANCOMYCIN HYDROCHLORIDE CAPSULE [ANI PHARMACEUTICALS, INC.] 1 gelatin INACTIVE INGREDIENT 2G86QN327L VANCOMYCIN HYDROCHLORIDE CAPSULE [ANI PHARMACEUTICALS, INC.] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A VANCOMYCIN HYDROCHLORIDE CAPSULE [ANI PHARMACEUTICALS, INC.] 1 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP VANCOMYCIN HYDROCHLORIDE CAPSULE [ANI PHARMACEUTICALS, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62559-391 VANCOMYCIN HYDROCHLORIDE CAPSULE [ANI PHARMACEUTICALS, INC.] 9 Current NDC, Legacy NDC, 3 package rows 20240802_3707ad2e-5c82-4111-a370-e518e5e7e4c5.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 Marketing end Sample Exclude flag Status 62559-391-20 62559039120 2 BLISTER PACK in 1 CARTON (62559-391-20) / 10 CAPSULE in 1 BLISTER PACK 2 blister pack 2015-10-26 0000-00-00 No No Current 62559-391-50 62559039150 50 CAPSULE in 1 BOTTLE (62559-391-50) 50 capsule 2016-12-20 0000-00-00 No No Current