Home NDC 0121-1598 Levetiracetam
Product NDC 0121-1598
11-digit product format 001211598
Labeler code 0121
Product ID 0121-1598_f63f4202-d0c1-4ef3-8dc5-8bb4cab6a613
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name LEVETIRACETAM
Dosage form SOLUTION
Route ORAL
Labeler PAI Holdings, LLC dba PAI Pharma
Application ANDA201157
Marketing category ANDA
Marketing start 2015-06-04
Substance LEVETIRACETAM
Active strength 1000 mg/10mL
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 A201157-001 LEVETIRACETAM LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2015-06-04
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A201157-001 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 A201157-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2015-06-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201157-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2015-06-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A201157-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2015-06-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201157-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2015-06-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201157-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2015-06-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201157-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2015-06-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201157-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2015-06-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201157-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2015-06-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201157-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2015-06-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A201157-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2015-06-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201157-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2015-06-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201157-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2015-06-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201157-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2015-06-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A201157-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2015-06-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201157-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2015-06-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A201157-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2015-06-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A201157-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2015-06-04 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A201157-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2015-06-04 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A201157-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2015-06-04 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A201157-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2015-06-04 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A201157-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2015-06-04 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A201157-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2015-06-04 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A201157-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2015-06-04 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A201157-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2015-06-04 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A201157-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2015-06-04 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A201157-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2015-06-04 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A201157-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2015-06-04 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A201157-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2015-06-04 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A201157-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2015-06-04 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A201157-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2015-06-04 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A201157-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2015-06-04 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A201157-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2015-06-04 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A201157-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2015-06-04 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A201157-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2015-06-04 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A201157-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2015-06-04 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A201157-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2015-06-04 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A201157-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2015-06-04 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A201157-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2015-06-04 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A201157-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2015-06-04 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A201157-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2015-06-04 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 Levetiracetam
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LEVETIRACETAM 1000 mg/10mL
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 0121-1598-10 Levetiracetam 10 mL in 1 CUP, UNIT-DOSE SOLUTION 10 23 0121-1598-20 Levetiracetam 2 in 1 CASE SOLUTION 2 23 0121-1598-20 Levetiracetam 10 in 1 TRAY SOLUTION 10 23 0121-1598-40 Levetiracetam 4 in 1 CASE SOLUTION 4 23 0121-1598-40 Levetiracetam 10 in 1 TRAY SOLUTION 10 23
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded LEVETIRACETAM ACTIVE INGREDIENT 44YRR34555 LEVETIRACETAM SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 6 LEVETIRACETAM ACTIVE MOIETY 44YRR34555 LEVETIRACETAM SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 6 ACESULFAME POTASSIUM INACTIVE INGREDIENT 23OV73Q5G9 LEVETIRACETAM SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 6 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP LEVETIRACETAM SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 6 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX LEVETIRACETAM SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 6 MALTITOL INACTIVE INGREDIENT D65DG142WK LEVETIRACETAM SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 6 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T LEVETIRACETAM SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 6 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH LEVETIRACETAM SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 6 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR LEVETIRACETAM SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 6 WATER INACTIVE INGREDIENT 059QF0KO0R LEVETIRACETAM SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0121-1598 LEVETIRACETAM SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA] 23 Current NDC, Legacy NDC, 5 package rows 20240507_9dca1330-52ca-47a4-a134-ec55c9d5786d.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 · 4 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 0121-1598-10 00121159810 10 mL in 1 CUP, UNIT-DOSE 10 ml Historical 0121-1598-20 00121159820 2 TRAY in 1 CASE (0121-1598-20) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-1598-10) 2 tray 2022-10-10 0000-00-00 No No Current 0121-1598-40 00121159840 4 TRAY in 1 CASE (0121-1598-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-1598-10) 4 tray 2015-06-04 0000-00-00 No No Current