Home NDC 68999-548 LEVETIRACETAM solution
Product NDC 68999-548
11-digit product format 689990548
Labeler code 68999
Product ID 68999-548_4357753b-846a-c5ea-e063-6394a90aa1ec
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name LEVETIRACETAM
Dosage form SOLUTION
Route ORAL
Labeler Chartwell Governmental & Specialty RX, LLC.
Application ANDA090263
Marketing category ANDA
Marketing start 2009-04-03
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 43 .
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 A090263-001 LEVETIRACETAM LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-04-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A090263-001 AA
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 · 43 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 2026-09-14 22:38:34 2026-08 A090263-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-04-03 84e616aacf4f…2026-08-18 06:07:40 2026-07 A090263-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-04-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090263-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-04-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090263-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-04-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090263-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-04-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090263-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-04-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090263-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-04-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090263-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-04-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090263-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-04-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090263-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-04-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090263-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-04-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090263-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-04-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090263-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-04-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090263-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-04-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090263-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-04-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090263-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-04-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090263-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-04-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090263-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-04-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090263-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-04-03 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090263-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-04-03 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090263-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-04-03 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090263-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-04-03 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090263-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-04-03 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090263-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-04-03 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090263-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-04-03 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090263-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-04-03 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090263-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-04-03 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090263-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-04-03 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090263-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-04-03 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090263-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-04-03 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090263-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-04-03 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090263-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-04-03 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090263-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-04-03 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090263-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-04-03 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090263-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-04-03 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090263-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-04-03 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090263-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-04-03 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090263-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-04-03 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090263-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-04-03 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090263-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-04-03 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base LEVETIRACETAM solution
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 403884 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 68999-548-24 LEVETIRACETAM solution 2 in 1 BOX SOLUTION 2 1 68999-548-24 LEVETIRACETAM solution 10 in 1 TRAY SOLUTION 10 1 68999-548-45 LEVETIRACETAM solution 5 mL in 1 CUP SOLUTION 5 1
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 Sample Exclude flag Status 68999-548-24 68999054824 2 TRAY in 1 BOX (68999-548-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (68999-548-45) 2 tray 2025-10-29 No No Current 68999-548-45 68999054845 5 mL in 1 CUP 5 ml Historical