Home NDC 25021-816 Leucovorin Calcium
Product NDC 25021-816
11-digit product format 250210816
Labeler code 25021
Product ID 25021-816_ff2ba160-e2f9-4ab9-9e67-2409f02c923e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name leucovorin calcium
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Sagent Pharmaceuticals
Application ANDA200855
Marketing category ANDA
Marketing start 2012-09-15
Substance LEUCOVORIN CALCIUM
Active strength 350 mg/17.5mL
Pharmacologic classes Folate Analog [EPC], Folic Acid [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 25021-816-67 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 25021-816-67 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 25021-816-67 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 25021-816-67 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 25021-816-67 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 25021-816-67 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 25021-816-67 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 25021-816-67 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 25021-816-67 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 25021-816-67 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 25021-816-67 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 25021-816-67 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A200855-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE LEUCOVORIN CALCIUM EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2012-09-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A200855-001 AP
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 · 41 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 A200855-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2012-09-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200855-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2012-09-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A200855-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2012-09-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200855-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2012-09-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200855-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2012-09-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200855-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2012-09-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200855-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2012-09-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200855-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2012-09-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200855-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2012-09-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A200855-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2012-09-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200855-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2012-09-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200855-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2012-09-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A200855-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2012-09-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A200855-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2012-09-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A200855-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2012-09-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A200855-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2012-09-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A200855-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2012-09-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A200855-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2012-09-06 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A200855-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2012-09-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A200855-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2012-09-06 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A200855-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2012-09-06 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A200855-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2012-09-06 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A200855-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2012-09-06 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A200855-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2012-09-06 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A200855-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2012-09-06 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A200855-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2012-09-06 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A200855-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2012-09-06 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A200855-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2012-09-06 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A200855-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2012-09-06 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A200855-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2012-09-06 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A200855-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2012-09-06 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A200855-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2012-09-06 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A200855-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2012-09-06 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A200855-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2012-09-06 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A200855-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2012-09-06 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A200855-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2012-09-06 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A200855-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2012-09-06 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A200855-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2012-09-06 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A200855-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2012-09-06 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A200855-001 LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2012-09-06 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Leucovorin Calcium
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LEUCOVORIN CALCIUM 350 mg/17.5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination RPR1R4C0P4 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 237788 Internal RxNorm lookup 1803930 Internal RxNorm lookup 1803932 Internal RxNorm lookup 1803937 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 25021-816-30 Leucovorin Calcium 17.5 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 17.5 9 25021-816-30 Leucovorin Calcium 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 9
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded leucovorin calcium ACTIVE INGREDIENT RPR1R4C0P4 LEUCOVORIN (LEUCOVORIN CALCIUM) INJECTION, POWDER, FOR SOLUTION [SAGENT PHARMACEUTICALS] 5 leucovorin ACTIVE MOIETY Q573I9DVLP LEUCOVORIN (LEUCOVORIN CALCIUM) INJECTION, POWDER, FOR SOLUTION [SAGENT PHARMACEUTICALS] 5 hydrochloric acid INACTIVE INGREDIENT QTT17582CB LEUCOVORIN (LEUCOVORIN CALCIUM) INJECTION, POWDER, FOR SOLUTION [SAGENT PHARMACEUTICALS] 5 sodium chloride INACTIVE INGREDIENT 451W47IQ8X LEUCOVORIN (LEUCOVORIN CALCIUM) INJECTION, POWDER, FOR SOLUTION [SAGENT PHARMACEUTICALS] 5 sodium hydroxide INACTIVE INGREDIENT 55X04QC32I LEUCOVORIN (LEUCOVORIN CALCIUM) INJECTION, POWDER, FOR SOLUTION [SAGENT PHARMACEUTICALS] 5 leucovorin calcium ACTIVE INGREDIENT RPR1R4C0P4 LEUCOVORIN (LEUCOVORIN CALCIUM) INJECTION, POWDER, FOR SOLUTION [SAGENT PHARMACEUTICALS] 3 leucovorin ACTIVE MOIETY Q573I9DVLP LEUCOVORIN (LEUCOVORIN CALCIUM) INJECTION, POWDER, FOR SOLUTION [SAGENT PHARMACEUTICALS] 3 hydrochloric acid INACTIVE INGREDIENT QTT17582CB LEUCOVORIN (LEUCOVORIN CALCIUM) INJECTION, POWDER, FOR SOLUTION [SAGENT PHARMACEUTICALS] 3 sodium chloride INACTIVE INGREDIENT 451W47IQ8X LEUCOVORIN (LEUCOVORIN CALCIUM) INJECTION, POWDER, FOR SOLUTION [SAGENT PHARMACEUTICALS] 3 sodium hydroxide INACTIVE INGREDIENT 55X04QC32I LEUCOVORIN (LEUCOVORIN CALCIUM) INJECTION, POWDER, FOR SOLUTION [SAGENT PHARMACEUTICALS] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 25021-816 LEUCOVORIN CALCIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SAGENT PHARMACEUTICALS] 9 Current NDC, Legacy NDC, 2 package rows 20221201_9d0e5356-ff39-4a8e-944c-e808a21ef4b2.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 25021-816-30 25021081630 1 VIAL in 1 CARTON (25021-816-30) / 17.5 mL in 1 VIAL 1 vial 2012-09-15 0000-00-00 No No Current 25021-816-67 25021081667 1 VIAL in 1 CARTON (25021-816-67) > 17.5 mL in 1 VIAL 1 vial 2013-12-01 2022-01-31 No No Current