Home NDC 0121-1033 VANCOMYCIN HYDROCHLORIDE
Product NDC 0121-1033
11-digit product format 001211033
Labeler code 0121
Product ID 0121-1033_1db451d1-f9ef-4e0a-8239-1c740369b64e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name VANCOMYCIN HYDROCHLORIDE
Dosage form CAPSULE
Route ORAL
Labeler PAI Holdings, LLC dba PAI Pharma
Application ANDA065478
Marketing category ANDA
Marketing start 2026-05-01
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 A065478-001 VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL AB 2012-04-09 A065478-002 VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL AB 2012-04-09
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 A065478-001 VANCOMYCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL 2012-04-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065478-002 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL 2012-04-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065478-001 VANCOMYCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL 2012-04-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065478-002 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL 2012-04-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065478-001 VANCOMYCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL 2012-04-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065478-002 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL 2012-04-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065478-001 VANCOMYCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL 2012-04-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065478-002 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL 2012-04-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065478-001 VANCOMYCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL 2012-04-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065478-002 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL 2012-04-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065478-001 VANCOMYCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL 2012-04-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065478-002 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL 2012-04-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065478-001 VANCOMYCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL 2012-04-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065478-002 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL 2012-04-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065478-001 VANCOMYCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL 2012-04-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065478-002 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL 2012-04-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065478-001 VANCOMYCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL 2012-04-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065478-002 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL 2012-04-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065478-001 VANCOMYCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL 2012-04-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065478-002 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL 2012-04-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065478-001 VANCOMYCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL 2012-04-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065478-002 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL 2012-04-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065478-001 VANCOMYCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL 2012-04-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065478-002 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL 2012-04-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065478-001 VANCOMYCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL 2012-04-09 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065478-002 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL 2012-04-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065478-001 VANCOMYCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL 2012-04-09 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A065478-002 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL 2012-04-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065478-001 VANCOMYCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL AB 2012-04-09 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065478-002 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL AB 2012-04-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065478-001 VANCOMYCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL AB 2012-04-09 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A065478-002 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL AB 2012-04-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065478-001 VANCOMYCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL AB 2012-04-09 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A065478-002 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL AB 2012-04-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065478-001 VANCOMYCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL AB 2012-04-09 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A065478-002 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL AB 2012-04-09 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065478-001 VANCOMYCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL AB 2012-04-09 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A065478-002 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL AB 2012-04-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065478-001 VANCOMYCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL AB 2012-04-09 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A065478-002 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL AB 2012-04-09 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 52 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 0121-1033-20 VANCOMYCIN HYDROCHLORIDE 2 in 1 CARTON CAPSULE 2 1 0121-1033-20 VANCOMYCIN HYDROCHLORIDE 10 in 1 BLISTER PACK CAPSULE 10 1 0121-1033-50 VANCOMYCIN HYDROCHLORIDE 50 in 1 BOTTLE CAPSULE 50 1
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 0121-1033-20 00121103320 2 BLISTER PACK in 1 CARTON (0121-1033-20) / 10 CAPSULE in 1 BLISTER PACK 2 blister pack 2026-05-01 No No Current 0121-1033-50 00121103350 50 CAPSULE in 1 BOTTLE (0121-1033-50) 50 capsule 2026-05-01 No No Current