Home NDC 72893-004 KHAPZORY
Product NDC 72893-004
11-digit product format 728930004
Labeler code 72893
Product ID 72893-004_4b8997a9-ddf8-4618-966a-291d583f24f7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name levoleucovorin
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Acrotech Biopharma Inc
Application NDA211226
Marketing category NDA
Marketing start 2019-01-02
Substance LEVOLEUCOVORIN DISODIUM
Active strength 175 mg/3.5mL
Pharmacologic classes Folate Analog [EPC], Folic Acid [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 N211226-001 KHAPZORY LEVOLEUCOVORIN 175MG/VIAL POWDER / INTRAVENOUS RLD, RS 2018-10-19 N211226-002 KHAPZORY LEVOLEUCOVORIN 300MG/VIAL POWDER / INTRAVENOUS RLD 2018-10-19
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N211226-001 11541012 2039-03-25 Drug product 2023-01-09 N211226-002 11541012 2039-03-25 Drug product 2023-01-09
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 N211226-001 KHAPZORY 175MG/VIAL POWDER / INTRAVENOUS RLD, RS 2018-10-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211226-002 KHAPZORY 300MG/VIAL POWDER / INTRAVENOUS RLD 2018-10-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211226-001 KHAPZORY 175MG/VIAL POWDER / INTRAVENOUS RLD, RS 2018-10-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211226-002 KHAPZORY 300MG/VIAL POWDER / INTRAVENOUS RLD 2018-10-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N211226-001 KHAPZORY 175MG/VIAL POWDER / INTRAVENOUS RLD, RS 2018-10-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211226-002 KHAPZORY 300MG/VIAL POWDER / INTRAVENOUS RLD 2018-10-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211226-001 KHAPZORY 175MG/VIAL POWDER / INTRAVENOUS RLD, RS 2018-10-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211226-002 KHAPZORY 300MG/VIAL POWDER / INTRAVENOUS RLD 2018-10-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211226-001 KHAPZORY 175MG/VIAL POWDER / INTRAVENOUS RLD, RS 2018-10-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211226-002 KHAPZORY 300MG/VIAL POWDER / INTRAVENOUS RLD 2018-10-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211226-001 KHAPZORY 175MG/VIAL POWDER / INTRAVENOUS RLD, RS 2018-10-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211226-002 KHAPZORY 300MG/VIAL POWDER / INTRAVENOUS RLD 2018-10-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211226-001 KHAPZORY 175MG/VIAL POWDER / INTRAVENOUS RLD, RS 2018-10-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211226-002 KHAPZORY 300MG/VIAL POWDER / INTRAVENOUS RLD 2018-10-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211226-001 KHAPZORY 175MG/VIAL POWDER / INTRAVENOUS RLD, RS 2018-10-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211226-002 KHAPZORY 300MG/VIAL POWDER / INTRAVENOUS RLD 2018-10-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N211226-001 KHAPZORY 175MG/VIAL POWDER / INTRAVENOUS RLD, RS 2018-10-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N211226-002 KHAPZORY 300MG/VIAL POWDER / INTRAVENOUS RLD 2018-10-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N211226-001 KHAPZORY 175MG/VIAL POWDER / INTRAVENOUS RLD, RS 2018-10-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N211226-002 KHAPZORY 300MG/VIAL POWDER / INTRAVENOUS RLD 2018-10-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N211226-001 KHAPZORY 175MG/VIAL POWDER / INTRAVENOUS RLD, RS 2018-10-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N211226-002 KHAPZORY 300MG/VIAL POWDER / INTRAVENOUS RLD 2018-10-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N211226-001 KHAPZORY 175MG/VIAL POWDER / INTRAVENOUS RLD, RS 2018-10-19 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N211226-002 KHAPZORY 300MG/VIAL POWDER / INTRAVENOUS RLD 2018-10-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N211226-001 KHAPZORY 175MG/VIAL POWDER / INTRAVENOUS RLD, RS 2018-10-19 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N211226-002 KHAPZORY 300MG/VIAL POWDER / INTRAVENOUS RLD 2018-10-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N211226-001 KHAPZORY 175MG/VIAL POWDER / INTRAVENOUS RLD, RS 2018-10-19 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N211226-002 KHAPZORY 300MG/VIAL POWDER / INTRAVENOUS RLD 2018-10-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N211226-001 KHAPZORY 175MG/VIAL POWDER / INTRAVENOUS RLD, RS 2018-10-19 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N211226-002 KHAPZORY 300MG/VIAL POWDER / INTRAVENOUS RLD, RS 2018-10-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N211226-001 KHAPZORY 175MG/VIAL POWDER / INTRAVENOUS RLD, RS 2018-10-19 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N211226-002 KHAPZORY 300MG/VIAL POWDER / INTRAVENOUS RLD, RS 2018-10-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N211226-001 KHAPZORY 175MG/VIAL POWDER / INTRAVENOUS RLD, RS 2018-10-19 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N211226-002 KHAPZORY 300MG/VIAL POWDER / INTRAVENOUS RLD, RS 2018-10-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N211226-001 KHAPZORY 175MG/VIAL POWDER / INTRAVENOUS RLD, RS 2018-10-19 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N211226-002 KHAPZORY 300MG/VIAL POWDER / INTRAVENOUS RLD, RS 2018-10-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N211226-001 KHAPZORY 175MG/VIAL POWDER / INTRAVENOUS RLD, RS 2018-10-19 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N211226-002 KHAPZORY 300MG/VIAL POWDER / INTRAVENOUS RLD, RS 2018-10-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N211226-001 KHAPZORY 175MG/VIAL POWDER / INTRAVENOUS RLD, RS 2018-10-19 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N211226-002 KHAPZORY 300MG/VIAL POWDER / INTRAVENOUS RLD, RS 2018-10-19 782e0a99824c…
Observed Orange Book patent history# Patent history page 1 of 2 · 46 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N211226-001 11541012 2039-03-25 Drug product 2023-01-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211226-002 11541012 2039-03-25 Drug product 2023-01-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211226-001 11541012 2039-03-25 Drug product 2023-01-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211226-002 11541012 2039-03-25 Drug product 2023-01-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N211226-001 11541012 2039-03-25 Drug product 2023-01-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211226-002 11541012 2039-03-25 Drug product 2023-01-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211226-001 11541012 2039-03-25 Drug product 2023-01-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211226-002 11541012 2039-03-25 Drug product 2023-01-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211226-001 11541012 2039-03-25 Drug product 2023-01-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211226-002 11541012 2039-03-25 Drug product 2023-01-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211226-001 11541012 2039-03-25 Drug product 2023-01-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211226-002 11541012 2039-03-25 Drug product 2023-01-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211226-001 11541012 2039-03-25 Drug product 2023-01-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211226-002 11541012 2039-03-25 Drug product 2023-01-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211226-001 11541012 2039-03-25 Drug product 2023-01-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211226-002 11541012 2039-03-25 Drug product 2023-01-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N211226-001 11541012 2039-03-25 Drug product 2023-01-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N211226-002 11541012 2039-03-25 Drug product 2023-01-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N211226-001 11541012 2039-03-25 Drug product 2023-01-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N211226-002 11541012 2039-03-25 Drug product 2023-01-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N211226-001 11541012 2039-03-25 Drug product 2023-01-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N211226-002 11541012 2039-03-25 Drug product 2023-01-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N211226-001 11541012 2039-03-25 Drug product 2023-01-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N211226-002 11541012 2039-03-25 Drug product 2023-01-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N211226-001 11541012 2039-03-25 Drug product 2023-01-09 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N211226-002 11541012 2039-03-25 Drug product 2023-01-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N211226-001 11541012 2039-03-25 Drug product 2023-01-09 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N211226-002 11541012 2039-03-25 Drug product 2023-01-09 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N211226-001 11541012 2039-03-25 Drug product 2023-01-09 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N211226-002 11541012 2039-03-25 Drug product 2023-01-09 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N211226-001 11541012 2039-03-25 Drug product 2023-01-09 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 N211226-002 11541012 2039-03-25 Drug product 2023-01-09 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N211226-001 11541012 2039-03-25 Drug product 2023-01-09 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 N211226-002 11541012 2039-03-25 Drug product 2023-01-09 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N211226-001 11541012 2039-03-25 Drug product 2023-01-09 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N211226-002 11541012 2039-03-25 Drug product 2023-01-09 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N211226-001 11541012 2039-03-25 Drug product 2023-01-09 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N211226-002 11541012 2039-03-25 Drug product 2023-01-09 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N211226-001 11541012 2039-03-25 Drug product 2023-01-09 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N211226-002 11541012 2039-03-25 Drug product 2023-01-09 a67488948f0b…
Additional Listing Data#
Finished product Yes
Brand name base KHAPZORY
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LEVOLEUCOVORIN DISODIUM 175 mg/3.5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5TXQ76K65T Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1858561 Internal RxNorm lookup 2106373 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 72893-004-01 KHAPZORY 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 12 72893-004-01 KHAPZORY 3.5 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 3.5 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72893-004 KHAPZORY (LEVOLEUCOVORIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACROTECH BIOPHARMA INC] 11 Current NDC, Legacy NDC, 2 package rows 20241213_344f65ac-9f04-49d7-b7c3-4ba19bd7b429.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 72893-004-01 72893000401 1 VIAL in 1 CARTON (72893-004-01) / 3.5 mL in 1 VIAL 1 vial 2019-01-02 0000-00-00 No No Current