Home NDC 0472-0235 Levetiracetam
Product NDC 0472-0235
11-digit product format 004720235
Labeler code 0472
Product ID 0472-0235_b64ea04d-69cd-4d88-885a-4210492d881c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Levetiracetam
Dosage form SOLUTION
Route ORAL
Labeler Actavis Pharma, Inc.
Application ANDA078976
Marketing category ANDA
Marketing start 2009-01-15
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 A078976-001 LEVETIRACETAM LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A078976-001 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 · 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 A078976-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078976-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078976-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078976-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078976-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078976-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078976-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078976-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078976-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078976-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078976-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078976-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078976-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078976-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078976-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078976-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078976-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078976-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078976-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078976-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078976-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078976-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078976-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078976-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078976-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078976-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078976-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078976-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078976-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078976-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078976-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078976-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078976-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078976-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078976-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078976-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078976-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A078976-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A078976-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A078976-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 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 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 0472-0235-16 Levetiracetam 473 mL in 1 BOTTLE, PLASTIC SOLUTION 473 22
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded LEVETIRACETAM ACTIVE INGREDIENT 44YRR34555 LEVETIRACETAM SOLUTION [ACTAVIS MID ATLANTIC LLC] 12 LEVETIRACETAM ACTIVE MOIETY 44YRR34555 LEVETIRACETAM SOLUTION [ACTAVIS MID ATLANTIC LLC] 12 ACESULFAME POTASSIUM INACTIVE INGREDIENT 23OV73Q5G9 LEVETIRACETAM SOLUTION [ACTAVIS MID ATLANTIC LLC] 12 AMMONIUM GLYCYRRHIZATE INACTIVE INGREDIENT 3VRD35U26C LEVETIRACETAM SOLUTION [ACTAVIS MID ATLANTIC LLC] 12 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP LEVETIRACETAM SOLUTION [ACTAVIS MID ATLANTIC LLC] 12 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX LEVETIRACETAM SOLUTION [ACTAVIS MID ATLANTIC LLC] 12 GRAPE INACTIVE INGREDIENT 6X543N684K LEVETIRACETAM SOLUTION [ACTAVIS MID ATLANTIC LLC] 12 MALTITOL INACTIVE INGREDIENT D65DG142WK LEVETIRACETAM SOLUTION [ACTAVIS MID ATLANTIC LLC] 12 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T LEVETIRACETAM SOLUTION [ACTAVIS MID ATLANTIC LLC] 12 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH LEVETIRACETAM SOLUTION [ACTAVIS MID ATLANTIC LLC] 12 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR LEVETIRACETAM SOLUTION [ACTAVIS MID ATLANTIC LLC] 12 WATER INACTIVE INGREDIENT 059QF0KO0R LEVETIRACETAM SOLUTION [ACTAVIS MID ATLANTIC LLC] 12 Levetiracetam ACTIVE INGREDIENT 44YRR34555 LEVETIRACETAM SOLUTION [VISTAPHARM, INC] 2 Levetiracetam ACTIVE MOIETY 44YRR34555 LEVETIRACETAM SOLUTION [VISTAPHARM, INC] 2 acesulfame potassium INACTIVE INGREDIENT 23OV73Q5G9 LEVETIRACETAM SOLUTION [VISTAPHARM, INC] 2 citric acid monohydrate INACTIVE INGREDIENT 2968PHW8QP LEVETIRACETAM SOLUTION [VISTAPHARM, INC] 2 glycerin INACTIVE INGREDIENT PDC6A3C0OX LEVETIRACETAM SOLUTION [VISTAPHARM, INC] 2 glycyrrhizin, ammoniated INACTIVE INGREDIENT 3VRD35U26C LEVETIRACETAM SOLUTION [VISTAPHARM, INC] 2 maltitol INACTIVE INGREDIENT D65DG142WK LEVETIRACETAM SOLUTION [VISTAPHARM, INC] 2 methylparaben INACTIVE INGREDIENT A2I8C7HI9T LEVETIRACETAM SOLUTION [VISTAPHARM, INC] 2 propylparaben INACTIVE INGREDIENT Z8IX2SC1OH LEVETIRACETAM SOLUTION [VISTAPHARM, INC] 2 trisodium citrate dihydrate INACTIVE INGREDIENT B22547B95K LEVETIRACETAM SOLUTION [VISTAPHARM, INC] 2 water INACTIVE INGREDIENT 059QF0KO0R LEVETIRACETAM SOLUTION [VISTAPHARM, INC] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0472-0235 LEVETIRACETAM SOLUTION [ACTAVIS PHARMA, INC.] 22 Current NDC, Legacy NDC, 1 package rows 20240625_5cb4a1db-f32d-44af-8985-0a94ca506468.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 0472-0235-16 00472023516 473 mL in 1 BOTTLE, PLASTIC (0472-0235-16) 473 ml 2009-01-15 0000-00-00 No No Current