Levetiracetam

Product NDC
65219-042
11-digit product format
652190042
Labeler code
65219
Product ID
65219-042_cf503053-d8bd-4546-b3f7-497c968dae67
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levetiracetam
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA208619
Marketing category
ANDA
Marketing start
2025-12-12
Substance
LEVETIRACETAM
Active strength
5 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A208619-001LEVETIRACETAM IN SODIUM CHLORIDELEVETIRACETAM500MG/100ML (5MG/ML)INJECTABLE / INTRAVENOUSAP2023-01-31
A208619-002LEVETIRACETAM IN SODIUM CHLORIDELEVETIRACETAM1GM/100ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2023-01-31
A208619-003LEVETIRACETAM IN SODIUM CHLORIDELEVETIRACETAM1.5GM/100ML (15MG/ML)INJECTABLE / INTRAVENOUSAP2023-01-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A208619-001AP
A208619-002AP
A208619-003AP

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 · 75 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A208619-001LEVETIRACETAM IN SODIUM CHLORIDE500MG/100ML (5MG/ML)INJECTABLE / INTRAVENOUSAP2023-01-3184e616aacf4f…
2026-09-14 22:38:342026-08A208619-002LEVETIRACETAM IN SODIUM CHLORIDE1GM/100ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2023-01-3184e616aacf4f…
2026-09-14 22:38:342026-08A208619-003LEVETIRACETAM IN SODIUM CHLORIDE1.5GM/100ML (15MG/ML)INJECTABLE / INTRAVENOUSAP2023-01-3184e616aacf4f…
2026-08-18 06:07:402026-07A208619-001LEVETIRACETAM IN SODIUM CHLORIDE500MG/100ML (5MG/ML)INJECTABLE / INTRAVENOUSAP2023-01-31caaa826d4ba7…
2026-08-18 06:07:402026-07A208619-002LEVETIRACETAM IN SODIUM CHLORIDE1GM/100ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2023-01-31caaa826d4ba7…
2026-08-18 06:07:402026-07A208619-003LEVETIRACETAM IN SODIUM CHLORIDE1.5GM/100ML (15MG/ML)INJECTABLE / INTRAVENOUSAP2023-01-31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208619-001LEVETIRACETAM IN SODIUM CHLORIDE500MG/100ML (5MG/ML)INJECTABLE / INTRAVENOUSAP2023-01-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208619-002LEVETIRACETAM IN SODIUM CHLORIDE1GM/100ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2023-01-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208619-003LEVETIRACETAM IN SODIUM CHLORIDE1.5GM/100ML (15MG/ML)INJECTABLE / INTRAVENOUSAP2023-01-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208619-001LEVETIRACETAM IN SODIUM CHLORIDE500MG/100ML (5MG/ML)INJECTABLE / INTRAVENOUSAP2023-01-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208619-002LEVETIRACETAM IN SODIUM CHLORIDE1GM/100ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2023-01-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208619-003LEVETIRACETAM IN SODIUM CHLORIDE1.5GM/100ML (15MG/ML)INJECTABLE / INTRAVENOUSAP2023-01-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208619-001LEVETIRACETAM IN SODIUM CHLORIDE500MG/100ML (5MG/ML)INJECTABLE / INTRAVENOUS2023-01-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208619-002LEVETIRACETAM IN SODIUM CHLORIDE1GM/100ML (10MG/ML)INJECTABLE / INTRAVENOUS2023-01-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208619-003LEVETIRACETAM IN SODIUM CHLORIDE1.5GM/100ML (15MG/ML)INJECTABLE / INTRAVENOUS2023-01-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208619-001LEVETIRACETAM IN SODIUM CHLORIDE500MG/100ML (5MG/ML)INJECTABLE / INTRAVENOUS2023-01-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208619-002LEVETIRACETAM IN SODIUM CHLORIDE1GM/100ML (10MG/ML)INJECTABLE / INTRAVENOUS2023-01-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208619-003LEVETIRACETAM IN SODIUM CHLORIDE1.5GM/100ML (15MG/ML)INJECTABLE / INTRAVENOUS2023-01-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208619-001LEVETIRACETAM IN SODIUM CHLORIDE500MG/100ML (5MG/ML)INJECTABLE / INTRAVENOUS2023-01-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208619-002LEVETIRACETAM IN SODIUM CHLORIDE1GM/100ML (10MG/ML)INJECTABLE / INTRAVENOUS2023-01-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208619-003LEVETIRACETAM IN SODIUM CHLORIDE1.5GM/100ML (15MG/ML)INJECTABLE / INTRAVENOUS2023-01-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208619-001LEVETIRACETAM IN SODIUM CHLORIDE500MG/100ML (5MG/ML)INJECTABLE / INTRAVENOUS2023-01-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208619-002LEVETIRACETAM IN SODIUM CHLORIDE1GM/100ML (10MG/ML)INJECTABLE / INTRAVENOUS2023-01-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208619-003LEVETIRACETAM IN SODIUM CHLORIDE1.5GM/100ML (15MG/ML)INJECTABLE / INTRAVENOUS2023-01-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208619-001LEVETIRACETAM IN SODIUM CHLORIDE500MG/100ML (5MG/ML)INJECTABLE / INTRAVENOUS2023-01-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208619-002LEVETIRACETAM IN SODIUM CHLORIDE1GM/100ML (10MG/ML)INJECTABLE / INTRAVENOUS2023-01-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208619-003LEVETIRACETAM IN SODIUM CHLORIDE1.5GM/100ML (15MG/ML)INJECTABLE / INTRAVENOUS2023-01-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208619-001LEVETIRACETAM IN SODIUM CHLORIDE500MG/100ML (5MG/ML)INJECTABLE / INTRAVENOUS2023-01-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208619-002LEVETIRACETAM IN SODIUM CHLORIDE1GM/100ML (10MG/ML)INJECTABLE / INTRAVENOUS2023-01-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208619-003LEVETIRACETAM IN SODIUM CHLORIDE1.5GM/100ML (15MG/ML)INJECTABLE / INTRAVENOUS2023-01-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208619-001LEVETIRACETAM IN SODIUM CHLORIDE500MG/100ML (5MG/ML)INJECTABLE / INTRAVENOUS2023-01-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208619-002LEVETIRACETAM IN SODIUM CHLORIDE1GM/100ML (10MG/ML)INJECTABLE / INTRAVENOUS2023-01-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208619-003LEVETIRACETAM IN SODIUM CHLORIDE1.5GM/100ML (15MG/ML)INJECTABLE / INTRAVENOUS2023-01-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208619-001LEVETIRACETAM IN SODIUM CHLORIDE500MG/100ML (5MG/ML)INJECTABLE / INTRAVENOUS2023-01-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A208619-002LEVETIRACETAM IN SODIUM CHLORIDE1GM/100ML (10MG/ML)INJECTABLE / INTRAVENOUS2023-01-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A208619-003LEVETIRACETAM IN SODIUM CHLORIDE1.5GM/100ML (15MG/ML)INJECTABLE / INTRAVENOUS2023-01-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208619-001LEVETIRACETAM IN SODIUM CHLORIDE500MG/100ML (5MG/ML)INJECTABLE / INTRAVENOUS2023-01-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208619-002LEVETIRACETAM IN SODIUM CHLORIDE1GM/100ML (10MG/ML)INJECTABLE / INTRAVENOUS2023-01-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208619-003LEVETIRACETAM IN SODIUM CHLORIDE1.5GM/100ML (15MG/ML)INJECTABLE / INTRAVENOUS2023-01-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208619-001LEVETIRACETAM IN SODIUM CHLORIDE500MG/100ML (5MG/ML)INJECTABLE / INTRAVENOUS2023-01-31301d65b070ca…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A208619-001AP184e616aacf4f…
2026-09-14 22:38:342026-08A208619-002AP184e616aacf4f…
2026-09-14 22:38:342026-08A208619-003AP184e616aacf4f…
2026-08-18 06:07:402026-07A208619-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A208619-002AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A208619-003AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208619-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208619-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208619-003AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208619-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208619-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208619-003AP131067a03dcf5…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A208619-001AP16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A208619-002AP16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A208619-003AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A208619-001AP11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A208619-002AP11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A208619-003AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A208619-001AP1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A208619-002AP1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A208619-003AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A208619-001AP1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A208619-002AP1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A208619-003AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A208619-001AP19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A208619-002AP19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A208619-003AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A208619-001AP1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A208619-002AP1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A208619-003AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A208619-001AP13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A208619-002AP13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A208619-003AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A208619-001AP1053a50430f4f…
2023-05-13 08:27 UTC2023-05A208619-002AP1053a50430f4f…
2023-05-13 08:27 UTC2023-05A208619-003AP1053a50430f4f…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A208619-001AP1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A208619-002AP1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A208619-003AP1a50c72e98297…

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
IngredientStrength
LEVETIRACETAM5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
44YRR34555Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1193358Internal RxNorm lookup
1193360Internal RxNorm lookup
1193362Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
da858849-1d18-4d38-b53d-d4dd1cd8fabcAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
76e81f18-c6b9-f226-530a-a6296d5cd5f4Product name620251106
087c9486-f4a9-a565-c6fb-d6fa49f4572aProduct name620230317
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
525a8d4d-1988-fc3f-e292-27fd384de4f0Product name820230104
32b651f8-caa7-6882-11c7-54c4ad21796bProduct name820201216
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
ce453ca5-90cf-41ed-9de4-de519f70a0f2Product name220160303
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
66666eb8-1fa6-4a60-bae9-e564e73b4cd5Product name120150728
eecbc0ef-ab5c-4ff9-8aaa-6ea73ee46477Product name120150410
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65219-042-21Levetiracetam100 mL in 1 BAGINJECTION1003
65219-042-71Levetiracetam24 in 1 CARTONINJECTION243

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65219-042-21ML - Milliliter65219-042ea34462c-ff88-48f5-b267-6691c53867ad12025-12-16
65219-042-71ML - Milliliter65219-0424f3c55b7-e3aa-4981-b3c3-3f440674c6ba12025-12-16

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LevetiracetamLEVETIRACETAMFresenius Kabi USA, LLCda858849-1d18-4d38-b53d-d4dd1cd8fabc2026-02-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208619
application number: ANDA208619
ndc (product): 65219-042
LevetiracetamLEVETIRACETAMHp Halden Pharma AS1d9abcce-8ef7-422b-bf4b-5835bf4dbb342025-11-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208619
application number: ANDA208619
LevetiracetamLEVETIRACETAMHp Halden Pharma AS6951de41-4a16-4cca-8039-44fc814070812025-11-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208619
application number: ANDA208619
LevetiracetamLEVETIRACETAMHp Halden Pharma AS35bb1e5f-d5cd-4e7f-a056-48c0cf9ebd762025-11-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208619
application number: ANDA208619

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1193358levETIRAcetam 1000 MG in 100 ML InjectionPSNda858849-1d18-4d38-b53d-d4dd1cd8fabc3
1193360levETIRAcetam 1500 MG in 100 ML InjectionPSNda858849-1d18-4d38-b53d-d4dd1cd8fabc3
1193362levETIRAcetam 500 MG in 100 ML InjectionPSNda858849-1d18-4d38-b53d-d4dd1cd8fabc3
1193358100 ML levetiracetam 10 MG/ML InjectionSCDda858849-1d18-4d38-b53d-d4dd1cd8fabc3
1193360100 ML levetiracetam 15 MG/ML InjectionSCDda858849-1d18-4d38-b53d-d4dd1cd8fabc3
1193362100 ML levetiracetam 5 MG/ML InjectionSCDda858849-1d18-4d38-b53d-d4dd1cd8fabc3
1193358levetiracetam 1000 MG per 100 ML InjectionSYda858849-1d18-4d38-b53d-d4dd1cd8fabc3
1193360levetiracetam 1500 MG per 100 ML InjectionSYda858849-1d18-4d38-b53d-d4dd1cd8fabc3
1193362levetiracetam 500 MG per 100 ML InjectionSYda858849-1d18-4d38-b53d-d4dd1cd8fabc3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65219-042-2165219004221100 mL in 1 BAG100 mlHistorical
65219-042-716521900427124 BAG in 1 CARTON (65219-042-71) / 100 mL in 1 BAG (65219-042-21) 24 bag2025-12-12NoNoCurrent