Home NDC 70069-845-10 Levetiracetam
Product NDC 70069-845
Requested package NDC 70069-845-10
11-digit product format 700690845
Labeler code 70069
Product ID 70069-845_1baa5928-7efe-4b91-94d6-787335ae60bd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Levetiracetam in Sodium Chloride
Dosage form INJECTION
Route INTRAVENOUS
Labeler Somerset Therapeutics, LLC
Application ANDA219562
Marketing category ANDA
Marketing start 2026-04-20
Substance LEVETIRACETAM
Active strength 500 mg/100mL
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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A219562-001 LEVETIRACETAM IN SODIUM CHLORIDE LEVETIRACETAM 500MG/100ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2025-01-16 A219562-002 LEVETIRACETAM IN SODIUM CHLORIDE LEVETIRACETAM 1GM/100ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2025-01-16 A219562-003 LEVETIRACETAM IN SODIUM CHLORIDE LEVETIRACETAM 1.5GM/100ML (15MG/ML) INJECTABLE / INTRAVENOUS AP 2025-01-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 A219562-001 LEVETIRACETAM IN SODIUM CHLORIDE 500MG/100ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2025-01-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 A219562-002 LEVETIRACETAM IN SODIUM CHLORIDE 1GM/100ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2025-01-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 A219562-003 LEVETIRACETAM IN SODIUM CHLORIDE 1.5GM/100ML (15MG/ML) INJECTABLE / INTRAVENOUS AP 2025-01-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 A219562-001 LEVETIRACETAM IN SODIUM CHLORIDE 500MG/100ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2025-01-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A219562-002 LEVETIRACETAM IN SODIUM CHLORIDE 1GM/100ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2025-01-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A219562-003 LEVETIRACETAM IN SODIUM CHLORIDE 1.5GM/100ML (15MG/ML) INJECTABLE / INTRAVENOUS AP 2025-01-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A219562-001 LEVETIRACETAM IN SODIUM CHLORIDE 500MG/100ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2025-01-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A219562-002 LEVETIRACETAM IN SODIUM CHLORIDE 1GM/100ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2025-01-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A219562-003 LEVETIRACETAM IN SODIUM CHLORIDE 1.5GM/100ML (15MG/ML) INJECTABLE / INTRAVENOUS AP 2025-01-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219562-001 LEVETIRACETAM IN SODIUM CHLORIDE 500MG/100ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2025-01-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219562-002 LEVETIRACETAM IN SODIUM CHLORIDE 1GM/100ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2025-01-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219562-003 LEVETIRACETAM IN SODIUM CHLORIDE 1.5GM/100ML (15MG/ML) INJECTABLE / INTRAVENOUS AP 2025-01-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A219562-001 LEVETIRACETAM IN SODIUM CHLORIDE 500MG/100ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2025-01-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A219562-002 LEVETIRACETAM IN SODIUM CHLORIDE 1GM/100ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2025-01-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A219562-003 LEVETIRACETAM IN SODIUM CHLORIDE 1.5GM/100ML (15MG/ML) INJECTABLE / INTRAVENOUS AP 2025-01-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A219562-001 LEVETIRACETAM IN SODIUM CHLORIDE 500MG/100ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2025-01-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A219562-002 LEVETIRACETAM IN SODIUM CHLORIDE 1GM/100ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2025-01-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A219562-003 LEVETIRACETAM IN SODIUM CHLORIDE 1.5GM/100ML (15MG/ML) INJECTABLE / INTRAVENOUS AP 2025-01-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A219562-001 LEVETIRACETAM IN SODIUM CHLORIDE 500MG/100ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2025-01-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A219562-002 LEVETIRACETAM IN SODIUM CHLORIDE 1GM/100ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2025-01-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A219562-003 LEVETIRACETAM IN SODIUM CHLORIDE 1.5GM/100ML (15MG/ML) INJECTABLE / INTRAVENOUS AP 2025-01-16 b8a1b40f171c…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219562-001 LEVETIRACETAM IN SODIUM CHLORIDE 500MG/100ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2025-01-16 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219562-002 LEVETIRACETAM IN SODIUM CHLORIDE 1GM/100ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2025-01-16 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219562-003 LEVETIRACETAM IN SODIUM CHLORIDE 1.5GM/100ML (15MG/ML) INJECTABLE / INTRAVENOUS AP 2025-01-16 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/100mL
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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1193358 Internal RxNorm lookup 1193360 Internal RxNorm lookup 1193362 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 70069-845-01 Levetiracetam 100 mL in 1 BAG INJECTION 100 2 70069-845-01 Levetiracetam 1 in 1 POUCH INJECTION 1 2 70069-845-10 Levetiracetam 10 in 1 CASE INJECTION 10 2
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 70069-845-10 70069084510 10 POUCH in 1 CASE (70069-845-10) / 1 BAG in 1 POUCH (70069-845-01) / 100 mL in 1 BAG 10 pouch 2026-04-20 No No Current