Home NDC 63323-400-05 Levetiracetam
Product NDC 63323-400
Requested package NDC 63323-400-05
11-digit product format 633230400
Labeler code 63323
Product ID 63323-400_799d949b-b1db-4e10-ab5c-89bf7c1bd308
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name LEVETIRACETAM
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application ANDA090876
Marketing category ANDA
Marketing start 2015-08-13
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 42 .
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 A090876-001 LEVETIRACETAM LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2015-08-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A090876-001 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.
Product history page 1 of 2 · 42 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 2026-08-18 06:07:40 2026-07 A090876-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2015-08-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090876-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2015-08-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090876-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2015-08-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090876-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2015-08-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090876-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2015-08-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090876-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2015-08-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090876-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2015-08-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090876-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2015-08-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090876-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2015-08-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090876-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2015-08-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090876-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2015-08-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090876-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2015-08-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090876-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2015-08-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090876-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2015-08-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090876-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2015-08-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090876-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2015-08-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090876-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2015-08-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090876-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2015-08-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090876-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2015-08-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090876-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2015-08-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090876-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2015-08-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090876-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2015-08-13 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090876-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2015-08-13 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090876-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2015-08-13 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090876-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2015-08-13 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090876-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2015-08-13 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090876-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2015-08-13 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090876-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2015-08-13 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090876-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2015-08-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090876-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2015-08-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090876-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2015-08-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090876-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2015-08-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090876-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2015-08-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090876-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2015-08-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090876-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2015-08-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090876-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2015-08-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090876-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2015-08-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090876-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2015-08-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090876-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2015-08-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A090876-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2015-08-13 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
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 63323-400-41 Levetiracetam 5 mL in 1 VIAL, SINGLE-USE INJECTION, SOLUTION 5 7 63323-400-44 Levetiracetam 10 in 1 TRAY INJECTION, SOLUTION 10 7 63323-400-01 Levetiracetam 5 mL in 1 VIAL, SINGLE-USE INJECTION, SOLUTION 5 6 63323-400-05 Levetiracetam 10 in 1 TRAY INJECTION, SOLUTION 10 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded LEVETIRACETAM ACTIVE INGREDIENT 44YRR34555 LEVETIRACETAM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 3 LEVETIRACETAM ACTIVE MOIETY 44YRR34555 LEVETIRACETAM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 3 ACETIC ACID INACTIVE INGREDIENT Q40Q9N063P LEVETIRACETAM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 3 SODIUM ACETATE INACTIVE INGREDIENT 4550K0SC9B LEVETIRACETAM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 3 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X LEVETIRACETAM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 3 WATER INACTIVE INGREDIENT 059QF0KO0R LEVETIRACETAM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63323-400 LEVETIRACETAM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC
] 7 Current NDC, Legacy NDC, 2 package rows 20220323_cc4a06f1-6509-4650-b20c-259a39353733.zip 63323-400 LEVETIRACETAM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 6 Current NDC, Legacy NDC, 2 package rows 20220222_cc41696c-9cf0-4410-bacc-09132ee805ce.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 Marketing start Marketing end Sample Exclude flag Status 63323-400-05 63323040005 10 VIAL, SINGLE-USE in 1 TRAY (63323-400-05) / 5 mL in 1 VIAL, SINGLE-USE (63323-400-01) 2015-08-13 0000-00-00 No No Current