Home NDC 50474-002 Keppra
Product NDC 50474-002
11-digit product format 504740002
Labeler code 50474
Product ID 50474-002_38cabb23-4e04-9a05-e063-6394a90a2a94
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name levetiracetam
Dosage form INJECTION, SOLUTION, CONCENTRATE
Route INTRAVENOUS
Labeler UCB, Inc.
Application NDA021872
Marketing category NDA
Marketing start 2006-08-23
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 N021872-001 KEPPRA LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-07-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021872-001 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 · 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 N021872-001 KEPPRA 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-07-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021872-001 KEPPRA 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-07-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021872-001 KEPPRA 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-07-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021872-001 KEPPRA 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-07-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021872-001 KEPPRA 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-07-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021872-001 KEPPRA 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-07-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021872-001 KEPPRA 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-07-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021872-001 KEPPRA 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-07-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021872-001 KEPPRA 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-07-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021872-001 KEPPRA 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-07-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021872-001 KEPPRA 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-07-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021872-001 KEPPRA 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-07-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021872-001 KEPPRA 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-07-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021872-001 KEPPRA 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-07-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021872-001 KEPPRA 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-07-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021872-001 KEPPRA 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-07-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021872-001 KEPPRA 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-07-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021872-001 KEPPRA 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-07-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021872-001 KEPPRA 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-07-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021872-001 KEPPRA 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-07-31 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021872-001 KEPPRA 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-07-31 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021872-001 KEPPRA 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-07-31 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021872-001 KEPPRA 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-07-31 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021872-001 KEPPRA 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-07-31 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021872-001 KEPPRA 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-07-31 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021872-001 KEPPRA 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-07-31 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021872-001 KEPPRA 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-07-31 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021872-001 KEPPRA 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-07-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021872-001 KEPPRA 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-07-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021872-001 KEPPRA 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-07-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021872-001 KEPPRA 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-07-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021872-001 KEPPRA 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-07-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021872-001 KEPPRA 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-07-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021872-001 KEPPRA 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-07-31 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021872-001 KEPPRA 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-07-31 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021872-001 KEPPRA 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-07-31 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021872-001 KEPPRA 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-07-31 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021872-001 KEPPRA 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-07-31 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021872-001 KEPPRA 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-07-31 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021872-001 KEPPRA 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-07-31 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 Keppra
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 647121 Internal RxNorm lookup 647123 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 50474-002-63 Keppra 10 in 1 CARTON INJECTION, SOLUTION, CONCENTRATE 10 29 50474-002-63 Keppra 5 mL in 1 VIAL, SINGLE-USE INJECTION, SOLUTION, CONCENTRATE 5 29
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded levetiracetam ACTIVE INGREDIENT 44YRR34555 KEPPRA (LEVETIRACETAM) INJECTION, SOLUTION, CONCENTRATE [UCB, INC.] 9 levetiracetam ACTIVE MOIETY 44YRR34555 KEPPRA (LEVETIRACETAM) INJECTION, SOLUTION, CONCENTRATE [UCB, INC.] 9 acetic acid INACTIVE INGREDIENT Q40Q9N063P KEPPRA (LEVETIRACETAM) INJECTION, SOLUTION, CONCENTRATE [UCB, INC.] 9 sodium acetate INACTIVE INGREDIENT 4550K0SC9B KEPPRA (LEVETIRACETAM) INJECTION, SOLUTION, CONCENTRATE [UCB, INC.] 9 sodium chloride INACTIVE INGREDIENT 451W47IQ8X KEPPRA (LEVETIRACETAM) INJECTION, SOLUTION, CONCENTRATE [UCB, INC.] 9 Water INACTIVE INGREDIENT 059QF0KO0R KEPPRA (LEVETIRACETAM) INJECTION, SOLUTION, CONCENTRATE [UCB, INC.] 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50474-002 KEPPRA (LEVETIRACETAM) INJECTION, SOLUTION, CONCENTRATE [UCB, INC.] 26 Current NDC, Legacy NDC, 2 package rows 20240322_c6d5784d-abf9-45fe-ac5a-d5c53bd50f7e.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 Marketing start Marketing end Sample Exclude flag Status 50474-002-63 50474000263 10 VIAL, SINGLE-USE in 1 CARTON (50474-002-63) / 5 mL in 1 VIAL, SINGLE-USE 2006-08-23 0000-00-00 No No Current