Home NDC 70752-203 LEVETIRACETAM
Product NDC 70752-203
11-digit product format 707520203
Labeler code 70752
Product ID 70752-203_339d66da-457a-4267-806b-7673122db283
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name LEVETIRACETAM
Dosage form SOLUTION
Route ORAL
Labeler QUAGEN PHARMACEUTICALS LLC
Application ANDA090079
Marketing category ANDA
Marketing start 2025-02-01
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 A090079-001 LEVETIRACETAM LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2012-04-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A090079-001 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 A090079-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2012-04-11 84e616aacf4f…2026-08-18 06:07:40 2026-07 A090079-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2012-04-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090079-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2012-04-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090079-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2012-04-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090079-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2012-04-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090079-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2012-04-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090079-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2012-04-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090079-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2012-04-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090079-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2012-04-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090079-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2012-04-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090079-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2012-04-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090079-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2012-04-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090079-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2012-04-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090079-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2012-04-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090079-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2012-04-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090079-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2012-04-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090079-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2012-04-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090079-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2012-04-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090079-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2012-04-11 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090079-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2012-04-11 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090079-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2012-04-11 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090079-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2012-04-11 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090079-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2012-04-11 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090079-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2012-04-11 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090079-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2012-04-11 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090079-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2012-04-11 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090079-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2012-04-11 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090079-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2012-04-11 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090079-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2012-04-11 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090079-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2012-04-11 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090079-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2012-04-11 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090079-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2012-04-11 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090079-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2012-04-11 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090079-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2012-04-11 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090079-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2012-04-11 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090079-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2012-04-11 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090079-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2012-04-11 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090079-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2012-04-11 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090079-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2012-04-11 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090079-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2012-04-11 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 2 · 43 observed states.
Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2022-09-29 23:25 UTC 2022-09 A090079-001 AA 1 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A090079-001 AA 1 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A090079-001 AA 1 a50c72e98297…
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
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 70752-203-02 LEVETIRACETAM 15 mL in 1 CUP, UNIT-DOSE SOLUTION 15 1 70752-203-02 LEVETIRACETAM 10 in 1 TRAY SOLUTION 10 1 70752-203-12 LEVETIRACETAM 473 mL in 1 BOTTLE SOLUTION 473 1 70752-203-16 LEVETIRACETAM 10 in 1 TRAY SOLUTION 10 1 70752-203-16 LEVETIRACETAM 5 mL in 1 CUP, UNIT-DOSE SOLUTION 5 1 70752-203-27 LEVETIRACETAM 10 mL in 1 CUP, UNIT-DOSE SOLUTION 10 1 70752-203-27 LEVETIRACETAM 10 in 1 TRAY SOLUTION 10 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70752-203 LEVETIRACETAM SOLUTION [QUAGEN PHARMACEUTICALS LLC] 1 Current NDC, 7 package rows 20250406_1d67cb3c-1173-4dce-a79b-a3c36934ab2e.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 Sample Exclude flag Status 70752-203-02 70752020302 10 CUP, UNIT-DOSE in 1 TRAY (70752-203-02) / 15 mL in 1 CUP, UNIT-DOSE 2025-02-01 No No Current 70752-203-12 70752020312 473 mL in 1 BOTTLE (70752-203-12) 473 ml 2025-02-01 No No Current 70752-203-16 70752020316 10 CUP, UNIT-DOSE in 1 TRAY (70752-203-16) / 5 mL in 1 CUP, UNIT-DOSE 2025-02-01 No No Current 70752-203-27 70752020327 10 CUP, UNIT-DOSE in 1 TRAY (70752-203-27) / 10 mL in 1 CUP, UNIT-DOSE 2025-02-01 No No Current