Home NDC 65162-685-86 Levetiracetam
Product NDC 65162-685
Requested package NDC 65162-685-86
11-digit product format 651620685
Labeler code 65162
Product ID 65162-685_118a42f5-1f6e-4cbb-b2ed-8a4c5beb1719
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Levetiracetam
Dosage form SOLUTION
Route ORAL
Labeler Amneal Pharmaceuticals LLC
Application ANDA090992
Marketing category ANDA
Marketing start 2009-10-27
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 A090992-001 LEVETIRACETAM LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-10-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A090992-001 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 A090992-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-10-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 A090992-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-10-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090992-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-10-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090992-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-10-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090992-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-10-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090992-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-10-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090992-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-10-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090992-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-10-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090992-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-10-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090992-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-10-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090992-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-10-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090992-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-10-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090992-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-10-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090992-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-10-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090992-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-10-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090992-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-10-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090992-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-10-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090992-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-10-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090992-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-10-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090992-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-10-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090992-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-10-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090992-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-10-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090992-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-10-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090992-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-10-27 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090992-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-10-27 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090992-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-10-27 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090992-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-10-27 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090992-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-10-27 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090992-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-10-27 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090992-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-10-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090992-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-10-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090992-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-10-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090992-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-10-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090992-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-10-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090992-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-10-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090992-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-10-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090992-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-10-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090992-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-10-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090992-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-10-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090992-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-10-27 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
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 65162-685-86 Levetiracetam 118 mL in 1 BOTTLE SOLUTION 118 34 65162-685-90 Levetiracetam 473 mL in 1 BOTTLE SOLUTION 473 34
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded LEVETIRACETAM ACTIVE INGREDIENT 44YRR34555 LEVETIRACETAM SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 23 LEVETIRACETAM ACTIVE MOIETY 44YRR34555 LEVETIRACETAM SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 23 ACESULFAME POTASSIUM INACTIVE INGREDIENT 23OV73Q5G9 LEVETIRACETAM SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 23 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL LEVETIRACETAM SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 23 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX LEVETIRACETAM SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 23 MALTITOL INACTIVE INGREDIENT D65DG142WK LEVETIRACETAM SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 23 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T LEVETIRACETAM SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 23 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH LEVETIRACETAM SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 23 SODIUM CITRATE, UNSPECIFIED FORM INACTIVE INGREDIENT 1Q73Q2JULR LEVETIRACETAM SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 23 LEVETIRACETAM ACTIVE INGREDIENT 44YRR34555 LEVETIRACETAM SOLUTION [ATLANTIC BIOLOGICALS CORPS] 3 LEVETIRACETAM ACTIVE MOIETY 44YRR34555 LEVETIRACETAM SOLUTION [ATLANTIC BIOLOGICALS CORPS] 3 ACESULFAME POTASSIUM INACTIVE INGREDIENT 23OV73Q5G9 LEVETIRACETAM SOLUTION [ATLANTIC BIOLOGICALS CORPS] 3 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL LEVETIRACETAM SOLUTION [ATLANTIC BIOLOGICALS CORPS] 3 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX LEVETIRACETAM SOLUTION [ATLANTIC BIOLOGICALS CORPS] 3 MALTITOL INACTIVE INGREDIENT D65DG142WK LEVETIRACETAM SOLUTION [ATLANTIC BIOLOGICALS CORPS] 3 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T LEVETIRACETAM SOLUTION [ATLANTIC BIOLOGICALS CORPS] 3 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH LEVETIRACETAM SOLUTION [ATLANTIC BIOLOGICALS CORPS] 3 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR LEVETIRACETAM SOLUTION [ATLANTIC BIOLOGICALS CORPS] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65162-685 LEVETIRACETAM SOLUTION [AMNEAL PHARMACEUTICALS LLC] 34 Current NDC, Legacy NDC, 2 package rows 20240625_5c4877cc-52bc-4f98-a995-0aa9439da742.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 · 1 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 65162-685-86 65162068586 118 mL in 1 BOTTLE (65162-685-86) 118 ml 2009-10-27 0000-00-00 No No Current