Home NDC 50474-001 Keppra
Product NDC 50474-001
11-digit product format 504740001
Labeler code 50474
Product ID 50474-001_4974b225-87ca-610e-e063-6294a90ad20a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name levetiracetam
Dosage form SOLUTION
Route ORAL
Labeler UCB, Inc.
Application NDA021505
Marketing category NDA
Marketing start 2003-10-20
Substance LEVETIRACETAM
Active strength 100 mg/mL
Pharmacologic classes Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag No
Listing certified through 2027-12-31
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 N021505-001 KEPPRA LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA RLD, RS 2003-07-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021505-001 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 N021505-001 KEPPRA 100MG/ML SOLUTION / ORAL AA RLD, RS 2003-07-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021505-001 KEPPRA 100MG/ML SOLUTION / ORAL AA RLD, RS 2003-07-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021505-001 KEPPRA 100MG/ML SOLUTION / ORAL AA RLD, RS 2003-07-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021505-001 KEPPRA 100MG/ML SOLUTION / ORAL AA RLD, RS 2003-07-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021505-001 KEPPRA 100MG/ML SOLUTION / ORAL AA RLD, RS 2003-07-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021505-001 KEPPRA 100MG/ML SOLUTION / ORAL AA RLD, RS 2003-07-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021505-001 KEPPRA 100MG/ML SOLUTION / ORAL AA RLD, RS 2003-07-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021505-001 KEPPRA 100MG/ML SOLUTION / ORAL AA RLD, RS 2003-07-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021505-001 KEPPRA 100MG/ML SOLUTION / ORAL AA RLD, RS 2003-07-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021505-001 KEPPRA 100MG/ML SOLUTION / ORAL AA RLD, RS 2003-07-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021505-001 KEPPRA 100MG/ML SOLUTION / ORAL AA RLD, RS 2003-07-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021505-001 KEPPRA 100MG/ML SOLUTION / ORAL AA RLD, RS 2003-07-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021505-001 KEPPRA 100MG/ML SOLUTION / ORAL AA RLD, RS 2003-07-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021505-001 KEPPRA 100MG/ML SOLUTION / ORAL AA RLD, RS 2003-07-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021505-001 KEPPRA 100MG/ML SOLUTION / ORAL AA RLD, RS 2003-07-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021505-001 KEPPRA 100MG/ML SOLUTION / ORAL AA RLD, RS 2003-07-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021505-001 KEPPRA 100MG/ML SOLUTION / ORAL AA RLD, RS 2003-07-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021505-001 KEPPRA 100MG/ML SOLUTION / ORAL AA RLD, RS 2003-07-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021505-001 KEPPRA 100MG/ML SOLUTION / ORAL AA RLD, RS 2003-07-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021505-001 KEPPRA 100MG/ML SOLUTION / ORAL AA RLD, RS 2003-07-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021505-001 KEPPRA 100MG/ML SOLUTION / ORAL AA RLD, RS 2003-07-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021505-001 KEPPRA 100MG/ML SOLUTION / ORAL AA RLD, RS 2003-07-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021505-001 KEPPRA 100MG/ML SOLUTION / ORAL AA RLD, RS 2003-07-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021505-001 KEPPRA 100MG/ML SOLUTION / ORAL AA RLD, RS 2003-07-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021505-001 KEPPRA 100MG/ML SOLUTION / ORAL AA RLD, RS 2003-07-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021505-001 KEPPRA 100MG/ML SOLUTION / ORAL AA RLD, RS 2003-07-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021505-001 KEPPRA 100MG/ML SOLUTION / ORAL AA RLD, RS 2003-07-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021505-001 KEPPRA 100MG/ML SOLUTION / ORAL AA RLD, RS 2003-07-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021505-001 KEPPRA 100MG/ML SOLUTION / ORAL AA RLD, RS 2003-07-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021505-001 KEPPRA 100MG/ML SOLUTION / ORAL AA RLD, RS 2003-07-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021505-001 KEPPRA 100MG/ML SOLUTION / ORAL AA RLD, RS 2003-07-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021505-001 KEPPRA 100MG/ML SOLUTION / ORAL AA RLD, RS 2003-07-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021505-001 KEPPRA 100MG/ML SOLUTION / ORAL AA RLD, RS 2003-07-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021505-001 KEPPRA 100MG/ML SOLUTION / ORAL AA RLD, RS 2003-07-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021505-001 KEPPRA 100MG/ML SOLUTION / ORAL AA RLD, RS 2003-07-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021505-001 KEPPRA 100MG/ML SOLUTION / ORAL AA RLD, RS 2003-07-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021505-001 KEPPRA 100MG/ML SOLUTION / ORAL AA RLD, RS 2003-07-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021505-001 KEPPRA 100MG/ML SOLUTION / ORAL AA RLD, RS 2003-07-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021505-001 KEPPRA 100MG/ML SOLUTION / ORAL AA RLD, RS 2003-07-15 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021505-001 KEPPRA 100MG/ML SOLUTION / ORAL AA RLD, RS 2003-07-15 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 Keppra
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 · 10 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 261335 Internal RxNorm lookup 261336 Internal RxNorm lookup 284391 Internal RxNorm lookup 311288 Internal RxNorm lookup 311289 Internal RxNorm lookup 311290 Internal RxNorm lookup 387003 Internal RxNorm lookup 403884 Internal RxNorm lookup 404595 Internal RxNorm lookup 630807 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 50474-001-48 Keppra 473 mL in 1 BOTTLE, PLASTIC SOLUTION 473 36
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded levetiracetam ACTIVE INGREDIENT 44YRR34555 KEPPRA (LEVETIRACETAM) TABLET, FILM COATED KEPPRA (LEVETIRACETAM) SOLUTION [UCB, INC.] 16 levetiracetam ACTIVE MOIETY 44YRR34555 KEPPRA (LEVETIRACETAM) TABLET, FILM COATED KEPPRA (LEVETIRACETAM) SOLUTION [UCB, INC.] 16 aluminum oxide INACTIVE INGREDIENT LMI26O6933 KEPPRA (LEVETIRACETAM) TABLET, FILM COATED KEPPRA (LEVETIRACETAM) SOLUTION [UCB, INC.] 16 ammonium glycyrrhizate INACTIVE INGREDIENT 3VRD35U26C KEPPRA (LEVETIRACETAM) TABLET, FILM COATED KEPPRA (LEVETIRACETAM) SOLUTION [UCB, INC.] 16 citric acid monohydrate INACTIVE INGREDIENT 2968PHW8QP KEPPRA (LEVETIRACETAM) TABLET, FILM COATED KEPPRA (LEVETIRACETAM) SOLUTION [UCB, INC.] 16 croscarmellose sodium INACTIVE INGREDIENT M28OL1HH48 KEPPRA (LEVETIRACETAM) TABLET, FILM COATED KEPPRA (LEVETIRACETAM) SOLUTION [UCB, INC.] 16 FD&C blue no. 2 INACTIVE INGREDIENT L06K8R7DQK KEPPRA (LEVETIRACETAM) TABLET, FILM COATED KEPPRA (LEVETIRACETAM) SOLUTION [UCB, INC.] 16 FD&C yellow no. 6 INACTIVE INGREDIENT H77VEI93A8 KEPPRA (LEVETIRACETAM) TABLET, FILM COATED KEPPRA (LEVETIRACETAM) SOLUTION [UCB, INC.] 16 ferric oxide red INACTIVE INGREDIENT 1K09F3G675 KEPPRA (LEVETIRACETAM) TABLET, FILM COATED KEPPRA (LEVETIRACETAM) SOLUTION [UCB, INC.] 16 ferric oxide yellow INACTIVE INGREDIENT EX438O2MRT KEPPRA (LEVETIRACETAM) TABLET, FILM COATED KEPPRA (LEVETIRACETAM) SOLUTION [UCB, INC.] 16 glycerin INACTIVE INGREDIENT PDC6A3C0OX KEPPRA (LEVETIRACETAM) TABLET, FILM COATED KEPPRA (LEVETIRACETAM) SOLUTION [UCB, INC.] 16 indigotindisulfonate sodium INACTIVE INGREDIENT D3741U8K7L KEPPRA (LEVETIRACETAM) TABLET, FILM COATED KEPPRA (LEVETIRACETAM) SOLUTION [UCB, INC.] 16 magnesium stearate INACTIVE INGREDIENT 70097M6I30 KEPPRA (LEVETIRACETAM) TABLET, FILM COATED KEPPRA (LEVETIRACETAM) SOLUTION [UCB, INC.] 16 methylparaben INACTIVE INGREDIENT A2I8C7HI9T KEPPRA (LEVETIRACETAM) TABLET, FILM COATED KEPPRA (LEVETIRACETAM) SOLUTION [UCB, INC.] 16 polyethylene glycol 3350 INACTIVE INGREDIENT G2M7P15E5P KEPPRA (LEVETIRACETAM) TABLET, FILM COATED KEPPRA (LEVETIRACETAM) SOLUTION [UCB, INC.] 16 polyethylene glycol 6000 INACTIVE INGREDIENT 30IQX730WE KEPPRA (LEVETIRACETAM) TABLET, FILM COATED KEPPRA (LEVETIRACETAM) SOLUTION [UCB, INC.] 16 polyvinyl alcohol INACTIVE INGREDIENT 532B59J990 KEPPRA (LEVETIRACETAM) TABLET, FILM COATED KEPPRA (LEVETIRACETAM) SOLUTION [UCB, INC.] 16 propylparaben INACTIVE INGREDIENT Z8IX2SC1OH KEPPRA (LEVETIRACETAM) TABLET, FILM COATED KEPPRA (LEVETIRACETAM) SOLUTION [UCB, INC.] 16 silicon dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 KEPPRA (LEVETIRACETAM) TABLET, FILM COATED KEPPRA (LEVETIRACETAM) SOLUTION [UCB, INC.] 16 talc INACTIVE INGREDIENT 7SEV7J4R1U KEPPRA (LEVETIRACETAM) TABLET, FILM COATED KEPPRA (LEVETIRACETAM) SOLUTION [UCB, INC.] 16 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP KEPPRA (LEVETIRACETAM) TABLET, FILM COATED KEPPRA (LEVETIRACETAM) SOLUTION [UCB, INC.] 16 trisodium citrate dihydrate INACTIVE INGREDIENT B22547B95K KEPPRA (LEVETIRACETAM) TABLET, FILM COATED KEPPRA (LEVETIRACETAM) SOLUTION [UCB, INC.] 16 water INACTIVE INGREDIENT 059QF0KO0R KEPPRA (LEVETIRACETAM) TABLET, FILM COATED KEPPRA (LEVETIRACETAM) SOLUTION [UCB, INC.] 16
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50474-001 KEPPRA (LEVETIRACETAM) TABLET, FILM COATED KEPPRA (LEVETIRACETAM) SOLUTION [UCB, INC.] 32 Current NDC, Legacy NDC, 1 package rows 20240430_3ca9df05-a506-4ec8-a4fe-320f1219ab21.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 50474-001-48 50474000148 473 mL in 1 BOTTLE, PLASTIC (50474-001-48) 473 ml 2003-10-20 0000-00-00 No No Current