Home NDC 72162-2638 Levetiracetam
Product NDC 72162-2638
11-digit product format 721622638
Labeler code 72162
Product ID 72162-2638_2051ef99-03d8-4b50-82d8-f7fb868d242d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Levetiracetam
Dosage form INJECTION, SOLUTION, CONCENTRATE
Route INTRAVENOUS
Labeler Bryant Ranch Prepack
Application ANDA215980
Marketing category ANDA
Marketing start 2022-11-15
Substance LEVETIRACETAM
Active strength 500 mg/5mL
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 A215980-001 LEVETIRACETAM LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2022-11-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215980-001 AP
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.
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 A215980-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2022-11-15 84e616aacf4f…2026-08-18 06:07:40 2026-07 A215980-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2022-11-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A215980-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2022-11-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215980-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2022-11-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215980-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2022-11-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215980-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2022-11-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215980-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2022-11-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215980-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2022-11-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215980-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2022-11-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215980-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2022-11-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215980-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2022-11-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215980-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2022-11-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215980-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2022-11-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215980-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2022-11-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215980-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2022-11-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215980-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2022-11-15 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215980-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2022-11-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215980-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2022-11-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A215980-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2022-11-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A215980-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2022-11-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A215980-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2022-11-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A215980-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2022-11-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A215980-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2022-11-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A215980-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2022-11-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A215980-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2022-11-15 3bdfa0b2c4d7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215980-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2022-11-15 a50c72e98297…
Observed Orange Book normalized TE history# 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 500 mg/5mL
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 647121 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 72162-2638-2 Levetiracetam 5 mL in 1 VIAL INJECTION, SOLUTION, CONCENTRATE 5 100 72162-2638-2 Levetiracetam 10 in 1 CARTON INJECTION, SOLUTION, CONCENTRATE 10 100 72162-2638-4 Levetiracetam 5 mL in 1 VIAL INJECTION, SOLUTION, CONCENTRATE 5 100 72162-2638-4 Levetiracetam 25 in 1 CARTON INJECTION, SOLUTION, CONCENTRATE 25 100
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 Units Marketing start Sample Exclude flag Status 72162-2638-2 72162263802 10 VIAL in 1 CARTON (72162-2638-2) / 5 mL in 1 VIAL 10 vial 2026-05-06 No No Current 72162-2638-4 72162263804 25 VIAL in 1 CARTON (72162-2638-4) / 5 mL in 1 VIAL 25 vial 2026-05-06 No No Current