Home NDC 42571-331-92 LEVETIRACETAM
Product NDC 42571-331
Requested package NDC 42571-331-92
11-digit product format 425710331
Labeler code 42571
Product ID 42571-331_1ccd66c0-e671-efb8-e063-6394a90aed04
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name LEVETIRACETAM
Dosage form INJECTION
Route INTRAVENOUS
Labeler Micro Labs Limited
Application ANDA211954
Marketing category ANDA
Marketing start 2019-10-04
Substance LEVETIRACETAM
Active strength 100 mg/mL
Pharmacologic classes Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag No
Listing certified through 2026-12-31
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A211954-001 LEVETIRACETAM LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2019-08-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A211954-001 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.
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 A211954-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2019-08-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211954-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2019-08-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211954-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2019-08-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211954-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2019-08-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211954-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2019-08-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211954-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2019-08-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211954-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2019-08-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211954-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2019-08-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211954-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2019-08-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211954-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2019-08-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211954-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2019-08-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211954-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2019-08-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211954-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2019-08-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211954-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2019-08-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211954-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2019-08-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211954-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2019-08-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211954-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2019-08-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A211954-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2019-08-09 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A211954-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2019-08-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211954-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2019-08-09 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A211954-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2019-08-09 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A211954-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2019-08-09 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A211954-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2019-08-09 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A211954-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2019-08-09 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A211954-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2019-08-09 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A211954-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2019-08-09 b00525d2431f…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211954-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2019-08-09 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211954-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2019-08-09 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211954-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2019-08-09 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211954-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2019-08-09 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211954-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2019-08-09 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211954-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2019-08-09 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A211954-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2019-08-09 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A211954-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2019-08-09 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A211954-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2019-08-09 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A211954-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2019-08-09 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A211954-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2019-08-09 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A211954-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2019-08-09 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A211954-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2019-08-09 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211954-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2019-08-09 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base LEVETIRACETAM
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LEVETIRACETAM 100 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 44YRR34555 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 647121 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 42571-331-92 LEVETIRACETAM 5 mL in 1 VIAL INJECTION 5 8 42571-331-92 LEVETIRACETAM 10 in 1 CARTON INJECTION 10 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42571-331 LEVETIRACETAM (LEVETIRACETAM) INJECTION [MICRO LABS LIMITED] 8 Current NDC, Legacy NDC, 2 package rows 20240710_1e3cfafe-5784-4ec6-91dc-cd74b01d0bb4.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 · 2 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 42571-331-92 42571033192 10 VIAL in 1 CARTON (42571-331-92) / 5 mL in 1 VIAL 10 vial 2019-10-04 0000-00-00 No No Current