Home NDC 51672-4136-9 Levetiracetam
Product NDC 51672-4136
Requested package NDC 51672-4136-9
11-digit product format 516724136
Labeler code 51672
Product ID 51672-4136_4db1dfc7-68f0-641e-e063-6294a90a6f67
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Levetiracetam
Dosage form SOLUTION
Route ORAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA078774
Marketing category ANDA
Marketing start 2009-02-10
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 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 A078774-001 LEVETIRACETAM LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-02-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A078774-001 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 · 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 A078774-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-02-10 84e616aacf4f…2026-08-18 06:07:40 2026-07 A078774-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-02-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078774-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-02-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078774-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-02-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078774-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-02-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078774-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-02-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078774-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-02-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078774-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-02-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078774-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-02-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078774-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-02-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078774-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-02-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078774-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-02-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078774-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-02-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078774-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-02-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078774-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-02-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078774-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-02-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078774-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-02-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078774-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-02-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078774-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-02-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078774-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-02-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078774-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-02-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078774-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-02-10 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078774-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-02-10 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078774-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-02-10 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078774-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-02-10 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078774-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-02-10 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078774-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-02-10 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078774-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-02-10 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078774-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-02-10 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078774-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-02-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078774-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-02-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078774-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-02-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078774-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-02-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078774-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-02-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078774-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-02-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078774-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-02-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078774-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-02-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078774-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-02-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A078774-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-02-10 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A078774-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-02-10 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 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 · 5 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 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 51672-4136-0 Levetiracetam 3785 mL in 1 BOTTLE SOLUTION 3785 15 51672-4136-7 Levetiracetam 100 mL in 1 BOTTLE SOLUTION 100 15 51672-4136-9 Levetiracetam 473 mL in 1 BOTTLE SOLUTION 473 15
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Levetiracetam ACTIVE INGREDIENT 44YRR34555 LEVETIRACETAM TABLET, FILM COATED LEVETIRACETAM SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] 9 Levetiracetam ACTIVE MOIETY 44YRR34555 LEVETIRACETAM TABLET, FILM COATED LEVETIRACETAM SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] 9 acesulfame potassium INACTIVE INGREDIENT 23OV73Q5G9 LEVETIRACETAM TABLET, FILM COATED LEVETIRACETAM SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] 9 aluminum oxide INACTIVE INGREDIENT LMI26O6933 LEVETIRACETAM TABLET, FILM COATED LEVETIRACETAM SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] 9 ammonium glycyrrhizate INACTIVE INGREDIENT 3VRD35U26C LEVETIRACETAM TABLET, FILM COATED LEVETIRACETAM SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] 9 citric acid monohydrate INACTIVE INGREDIENT 2968PHW8QP LEVETIRACETAM TABLET, FILM COATED LEVETIRACETAM SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] 9 FD&C Blue no. 2 INACTIVE INGREDIENT L06K8R7DQK LEVETIRACETAM TABLET, FILM COATED LEVETIRACETAM SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] 9 ferric oxide red INACTIVE INGREDIENT 1K09F3G675 LEVETIRACETAM TABLET, FILM COATED LEVETIRACETAM SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] 9 ferric oxide yellow INACTIVE INGREDIENT EX438O2MRT LEVETIRACETAM TABLET, FILM COATED LEVETIRACETAM SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] 9 ferrosoferric oxide INACTIVE INGREDIENT XM0M87F357 LEVETIRACETAM TABLET, FILM COATED LEVETIRACETAM SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] 9 glycerin INACTIVE INGREDIENT PDC6A3C0OX LEVETIRACETAM TABLET, FILM COATED LEVETIRACETAM SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] 9 hypromelloses INACTIVE INGREDIENT 3NXW29V3WO LEVETIRACETAM TABLET, FILM COATED LEVETIRACETAM SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] 9 indigotindisulfonate sodium INACTIVE INGREDIENT D3741U8K7L LEVETIRACETAM TABLET, FILM COATED LEVETIRACETAM SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] 9 magnesium stearate INACTIVE INGREDIENT 70097M6I30 LEVETIRACETAM TABLET, FILM COATED LEVETIRACETAM SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] 9 methylparaben INACTIVE INGREDIENT A2I8C7HI9T LEVETIRACETAM TABLET, FILM COATED LEVETIRACETAM SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] 9 polyethylene glycols INACTIVE INGREDIENT 3WJQ0SDW1A LEVETIRACETAM TABLET, FILM COATED LEVETIRACETAM SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] 9 povidones INACTIVE INGREDIENT FZ989GH94E LEVETIRACETAM TABLET, FILM COATED LEVETIRACETAM SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] 9 propylparaben INACTIVE INGREDIENT Z8IX2SC1OH LEVETIRACETAM TABLET, FILM COATED LEVETIRACETAM SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] 9 silicon dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 LEVETIRACETAM TABLET, FILM COATED LEVETIRACETAM SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] 9 starch, corn INACTIVE INGREDIENT O8232NY3SJ LEVETIRACETAM TABLET, FILM COATED LEVETIRACETAM SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] 9 talc INACTIVE INGREDIENT 7SEV7J4R1U LEVETIRACETAM TABLET, FILM COATED LEVETIRACETAM SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] 9 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP LEVETIRACETAM TABLET, FILM COATED LEVETIRACETAM SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] 9 trisodium citrate dihydrate INACTIVE INGREDIENT B22547B95K LEVETIRACETAM TABLET, FILM COATED LEVETIRACETAM SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] 9 water INACTIVE INGREDIENT 059QF0KO0R LEVETIRACETAM TABLET, FILM COATED LEVETIRACETAM SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51672-4136 LEVETIRACETAM TABLET, FILM COATED LEVETIRACETAM SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] 12 Current NDC, Legacy NDC, 3 package rows 20200723_bf412e94-ca36-4da9-83d7-fb0f1323cf21.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 51672-4136-9 51672413609 473 mL in 1 BOTTLE (51672-4136-9) 473 ml 2009-02-10 0000-00-00 No No Current