Home NDC 16714-890-01 LEVOLEUCOVORIN
Product NDC 16714-890
Requested package NDC 16714-890-01
11-digit product format 167140890
Labeler code 16714
Product ID 16714-890_a133917e-1ae8-1bbd-152b-58a5a07769b7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name LEVOLEUCOVORIN
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler NorthStar RxLLC
Application ANDA210892
Marketing category ANDA
Marketing start 2018-09-26
Marketing end 0000-00-00
Substance LEVOLEUCOVORIN CALCIUM
Active strength 175 mg/17.5mL
Pharmacologic classes Folate Analog [EPC], Folic Acid [CS]
NDC exclude flag No
Listing certified through 2023-12-31
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 A210892-001 LEVOLEUCOVORIN CALCIUM LEVOLEUCOVORIN CALCIUM EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS AP 2018-09-14 A210892-002 LEVOLEUCOVORIN CALCIUM LEVOLEUCOVORIN CALCIUM EQ 250MG BASE/25ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS AP RS 2018-09-14
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 A210892-001 LEVOLEUCOVORIN CALCIUM EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS AP 2018-09-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210892-002 LEVOLEUCOVORIN CALCIUM EQ 250MG BASE/25ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS AP RS 2018-09-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210892-001 LEVOLEUCOVORIN CALCIUM EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS AP 2018-09-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210892-002 LEVOLEUCOVORIN CALCIUM EQ 250MG BASE/25ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS AP RS 2018-09-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210892-001 LEVOLEUCOVORIN CALCIUM EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS AP 2018-09-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210892-002 LEVOLEUCOVORIN CALCIUM EQ 250MG BASE/25ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS AP RS 2018-09-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210892-001 LEVOLEUCOVORIN CALCIUM EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS AP 2018-09-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210892-002 LEVOLEUCOVORIN CALCIUM EQ 250MG BASE/25ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS AP RS 2018-09-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210892-001 LEVOLEUCOVORIN CALCIUM EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS AP 2018-09-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210892-002 LEVOLEUCOVORIN CALCIUM EQ 250MG BASE/25ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS AP RS 2018-09-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210892-001 LEVOLEUCOVORIN CALCIUM EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS AP 2018-09-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210892-002 LEVOLEUCOVORIN CALCIUM EQ 250MG BASE/25ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS AP RS 2018-09-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210892-001 LEVOLEUCOVORIN CALCIUM EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS AP 2018-09-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210892-002 LEVOLEUCOVORIN CALCIUM EQ 250MG BASE/25ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS AP RS 2018-09-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210892-001 LEVOLEUCOVORIN CALCIUM EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS AP 2018-09-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210892-002 LEVOLEUCOVORIN CALCIUM EQ 250MG BASE/25ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS AP RS 2018-09-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210892-001 LEVOLEUCOVORIN CALCIUM EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS AP 2018-09-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210892-002 LEVOLEUCOVORIN CALCIUM EQ 250MG BASE/25ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS AP RS 2018-09-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210892-001 LEVOLEUCOVORIN CALCIUM EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS AP 2018-09-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A210892-002 LEVOLEUCOVORIN CALCIUM EQ 250MG BASE/25ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS AP RS 2018-09-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210892-001 LEVOLEUCOVORIN CALCIUM EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS AP 2018-09-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210892-002 LEVOLEUCOVORIN CALCIUM EQ 250MG BASE/25ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS AP RS 2018-09-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210892-001 LEVOLEUCOVORIN CALCIUM EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS AP 2018-09-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210892-002 LEVOLEUCOVORIN CALCIUM EQ 250MG BASE/25ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS AP RS 2018-09-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210892-001 LEVOLEUCOVORIN CALCIUM EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS AP 2018-09-14 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210892-002 LEVOLEUCOVORIN CALCIUM EQ 250MG BASE/25ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS AP RS 2018-09-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210892-001 LEVOLEUCOVORIN CALCIUM EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS AP 2018-09-14 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A210892-002 LEVOLEUCOVORIN CALCIUM EQ 250MG BASE/25ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS AP RS 2018-09-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210892-001 LEVOLEUCOVORIN CALCIUM EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS AP RS 2018-09-14 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210892-002 LEVOLEUCOVORIN CALCIUM EQ 250MG BASE/25ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS AP RS 2018-09-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210892-001 LEVOLEUCOVORIN CALCIUM EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS AP RS 2018-09-14 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A210892-002 LEVOLEUCOVORIN CALCIUM EQ 250MG BASE/25ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS AP RS 2018-09-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210892-001 LEVOLEUCOVORIN CALCIUM EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS AP RS 2018-09-14 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A210892-002 LEVOLEUCOVORIN CALCIUM EQ 250MG BASE/25ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS AP RS 2018-09-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A210892-001 LEVOLEUCOVORIN CALCIUM EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS AP 2018-09-14 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A210892-002 LEVOLEUCOVORIN CALCIUM EQ 250MG BASE/25ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS AP 2018-09-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A210892-001 LEVOLEUCOVORIN CALCIUM EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS AP RS 2018-09-14 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A210892-002 LEVOLEUCOVORIN CALCIUM EQ 250MG BASE/25ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS AP RS 2018-09-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210892-001 LEVOLEUCOVORIN CALCIUM EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS AP 2018-09-14 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A210892-002 LEVOLEUCOVORIN CALCIUM EQ 250MG BASE/25ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS AP 2018-09-14 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 80 observed states.
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 · 2 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 16714-890-01 16714089001 1 VIAL, SINGLE-DOSE in 1 CARTON (16714-890-01) > 17.5 mL in 1 VIAL, SINGLE-DOSE 2018-09-26 0000-00-00 No No Current