Home NDC 70518-3804 Levetiracetam
Product NDC 70518-3804
11-digit product format 705183804
Labeler code 70518
Product ID 70518-3804_3b296ca7-548a-49c3-e063-6394a90a1849
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Levetiracetam
Dosage form SOLUTION
Route ORAL
Labeler REMEDYREPACK INC.
Application ANDA079063
Marketing category ANDA
Marketing start 2023-07-24
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 A079063-001 LEVETIRACETAM LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A079063-001 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 · 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 A079063-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079063-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A079063-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079063-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079063-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079063-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079063-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079063-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A079063-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A079063-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A079063-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A079063-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A079063-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A079063-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A079063-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A079063-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A079063-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A079063-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A079063-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A079063-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A079063-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A079063-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A079063-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A079063-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A079063-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A079063-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A079063-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A079063-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A079063-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A079063-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A079063-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A079063-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A079063-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A079063-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A079063-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A079063-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A079063-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A079063-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A079063-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A079063-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 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 Levetiracetam
Listing expiration 2027-12-31 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 70518-3804-0 Levetiracetam 10 in 1 BOX SOLUTION 10 6 70518-3804-1 Levetiracetam 10 mL in 1 CUP, UNIT-DOSE SOLUTION 10 6 70518-3804-2 Levetiracetam 10 in 1 BOX SOLUTION 10 6 70518-3804-3 Levetiracetam 25 mL in 1 CUP, UNIT-DOSE SOLUTION 25 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70518-3804 LEVETIRACETAM SOLUTION [REMEDYREPACK INC.] 5 Current NDC, 4 package rows 20250429_74ccc9f1-b957-4b1b-9464-1b5e3318c916.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 · 4 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 70518-3804-0 70518380400 10 CUP, UNIT-DOSE in 1 BOX (70518-3804-0) / 10 mL in 1 CUP, UNIT-DOSE (70518-3804-1) 2023-07-24 No No Current 70518-3804-1 70518380401 10 mL in 1 CUP, UNIT-DOSE 10 ml Historical 70518-3804-2 70518380402 10 CUP, UNIT-DOSE in 1 BOX (70518-3804-2) / 25 mL in 1 CUP, UNIT-DOSE (70518-3804-3) 2023-07-24 No No Current 70518-3804-3 70518380403 25 mL in 1 CUP, UNIT-DOSE 25 ml Historical