Home NDC 68180-115-02 Levetiracetam
Product NDC 68180-115
Requested package NDC 68180-115-02
11-digit product format 681800115
Labeler code 68180
Product ID 68180-115_24fe2e98-0b9f-4eea-a745-e26002329cec
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Levetiracetam
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Lupin Pharmaceuticals, Inc.
Application ANDA090025
Marketing category ANDA
Marketing start 2009-01-15
Substance LEVETIRACETAM
Active strength 1000 mg/1
Pharmacologic classes Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A090025-001 LEVETIRACETAM LEVETIRACETAM 1GM TABLET / ORAL AB 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 A090025-001 AB
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 · 43 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 2026-09-14 22:38:34 2026-08 A090025-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 84e616aacf4f…2026-08-18 06:07:40 2026-07 A090025-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090025-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090025-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090025-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090025-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090025-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090025-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090025-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090025-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090025-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090025-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090025-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090025-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090025-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090025-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090025-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090025-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090025-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090025-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090025-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090025-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090025-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090025-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090025-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090025-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090025-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090025-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090025-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090025-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090025-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090025-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090025-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090025-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090025-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090025-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090025-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090025-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090025-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090025-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Levetiracetam
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LEVETIRACETAM 1000 mg/1
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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 311288 Internal RxNorm lookup 311289 Internal RxNorm lookup 311290 Internal RxNorm lookup 387003 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 68180-115-02 Levetiracetam 500 in 1 BOTTLE TABLET, FILM COATED 500 26 68180-115-07 Levetiracetam 60 in 1 BOTTLE TABLET, FILM COATED 60 26 68180-115-02 Levetiracetam 500 in 1 BOTTLE TABLET, FILM COATED 500 1 68180-115-07 Levetiracetam 60 in 1 BOTTLE TABLET, FILM COATED 60 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded LEVETIRACETAM ACTIVE INGREDIENT 44YRR34555 LEVETIRACETAM TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] 8 LEVETIRACETAM ACTIVE MOIETY 44YRR34555 LEVETIRACETAM TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] 8 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U LEVETIRACETAM TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] 8 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 LEVETIRACETAM TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] 8 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 LEVETIRACETAM TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] 8 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK LEVETIRACETAM TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] 8 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK LEVETIRACETAM TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] 8 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 LEVETIRACETAM TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] 8 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 LEVETIRACETAM TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] 8 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT LEVETIRACETAM TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] 8 HYPROMELLOSE 2910 (3 MPA.S) INACTIVE INGREDIENT 0VUT3PMY82 LEVETIRACETAM TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] 8 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 LEVETIRACETAM TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] 8 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LEVETIRACETAM TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] 8 POLYETHYLENE GLYCOL 4000 INACTIVE INGREDIENT 4R4HFI6D95 LEVETIRACETAM TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] 8 POLYETHYLENE GLYCOL 6000 INACTIVE INGREDIENT 30IQX730WE LEVETIRACETAM TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] 8 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 LEVETIRACETAM TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] 8 POVIDONE INACTIVE INGREDIENT FZ989GH94E LEVETIRACETAM TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] 8 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ LEVETIRACETAM TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] 8 TALC INACTIVE INGREDIENT 7SEV7J4R1U LEVETIRACETAM TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] 8 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP LEVETIRACETAM TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] 8 LEVETIRACETAM ACTIVE INGREDIENT 44YRR34555 LEVETIRACETAM TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC] 1 LEVETIRACETAM ACTIVE MOIETY 44YRR34555 LEVETIRACETAM TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U LEVETIRACETAM TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 LEVETIRACETAM TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LEVETIRACETAM TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC] 1 POLYETHYLENE GLYCOL INACTIVE INGREDIENT 3WJQ0SDW1A LEVETIRACETAM TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC] 1 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 LEVETIRACETAM TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC] 1 POVIDONE INACTIVE INGREDIENT FZ989GH94E LEVETIRACETAM TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 LEVETIRACETAM TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ LEVETIRACETAM TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U LEVETIRACETAM TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP LEVETIRACETAM TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68180-115 LEVETIRACETAM TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] 23 Current NDC, Legacy NDC, 2 package rows 20240418_df661166-325d-4071-9bc1-f7bf992996d2.zip 68180-115 LEVETIRACETAM TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC] 1 Current NDC, Legacy NDC, 2 package rows 20101130_e196c127-c081-43a7-8f0d-be3e2b434b50.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 68180-115-02 68180011502 500 TABLET, FILM COATED in 1 BOTTLE (68180-115-02) 2009-01-15 0000-00-00 No No Current