Home NDC 68152-114-01 KHAPZORY
Product NDC 68152-114
Requested package NDC 68152-114-01
11-digit product format 681520114
Labeler code 68152
Product ID 68152-114_9a969df4-28f8-4a1d-81a7-204f06d61dec
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name levoleucovorin
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Spectrum Pharmaceuticals, Inc.
Application NDA211226
Marketing category NDA
Marketing start 2019-01-02
Marketing end 0000-00-00
Substance LEVOLEUCOVORIN DISODIUM
Active strength 300 mg/6mL
Pharmacologic classes Folate Analog [EPC],Folic Acid [CS]
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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…
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join KHAPZORY LEVOLEUCOVORIN Acrotech Biopharma Inc 344f65ac-9f04-49d7-b7c3-4ba19bd7b429 2026-03-17 Warnings, Adverse reactions Exact identifier application applno (NDA): 211226 application number: NDA211226
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68152-114-01 68152011401 1 VIAL in 1 CARTON (68152-114-01) > 6 mL in 1 VIAL 1 vial 2019-01-02 0000-00-00 No No Current