LEVETIRACETAM

Product NDC
0409-1886
Requested package NDC
0409-1886-05
11-digit product format
004091886
Labeler code
0409
Product ID
0409-1886_ba064ae4-ae86-4fc4-b0a9-0477d8db8727
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LEVETIRACETAM
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Hospira, Inc.
Application
ANDA202869
Marketing category
ANDA
Marketing start
2012-11-02
Substance
LEVETIRACETAM
Active strength
100 mg/mL
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0409-18860409-1886-05DDiscontinued by firm2026-08-11

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 dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202869-001LEVETIRACETAMLEVETIRACETAM500MG/5ML (100MG/ML)INJECTABLE / INTRAVENOUSAP2012-04-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A202869-001AP

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A202869-001LEVETIRACETAM500MG/5ML (100MG/ML)INJECTABLE / INTRAVENOUSAP2012-04-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202869-001LEVETIRACETAM500MG/5ML (100MG/ML)INJECTABLE / INTRAVENOUSAP2012-04-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A202869-001LEVETIRACETAM500MG/5ML (100MG/ML)INJECTABLE / INTRAVENOUSAP2012-04-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202869-001LEVETIRACETAM500MG/5ML (100MG/ML)INJECTABLE / INTRAVENOUSAP2012-04-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202869-001LEVETIRACETAM500MG/5ML (100MG/ML)INJECTABLE / INTRAVENOUSAP2012-04-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202869-001LEVETIRACETAM500MG/5ML (100MG/ML)INJECTABLE / INTRAVENOUSAP2012-04-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202869-001LEVETIRACETAM500MG/5ML (100MG/ML)INJECTABLE / INTRAVENOUSAP2012-04-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202869-001LEVETIRACETAM500MG/5ML (100MG/ML)INJECTABLE / INTRAVENOUSAP2012-04-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202869-001LEVETIRACETAM500MG/5ML (100MG/ML)INJECTABLE / INTRAVENOUSAP2012-04-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202869-001LEVETIRACETAM500MG/5ML (100MG/ML)INJECTABLE / INTRAVENOUSAP2012-04-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202869-001LEVETIRACETAM500MG/5ML (100MG/ML)INJECTABLE / INTRAVENOUSAP2012-04-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202869-001LEVETIRACETAM500MG/5ML (100MG/ML)INJECTABLE / INTRAVENOUSAP2012-04-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202869-001LEVETIRACETAM500MG/5ML (100MG/ML)INJECTABLE / INTRAVENOUSAP2012-04-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202869-001LEVETIRACETAM500MG/5ML (100MG/ML)INJECTABLE / INTRAVENOUSAP2012-04-068072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202869-001LEVETIRACETAM500MG/5ML (100MG/ML)INJECTABLE / INTRAVENOUSAP2012-04-065c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202869-001LEVETIRACETAM500MG/5ML (100MG/ML)INJECTABLE / INTRAVENOUSAP2012-04-065d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202869-001LEVETIRACETAM500MG/5ML (100MG/ML)INJECTABLE / INTRAVENOUSAP2012-04-064b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202869-001LEVETIRACETAM500MG/5ML (100MG/ML)INJECTABLE / INTRAVENOUSAP2012-04-0674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202869-001LEVETIRACETAM500MG/5ML (100MG/ML)INJECTABLE / INTRAVENOUSAP2012-04-06bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202869-001LEVETIRACETAM500MG/5ML (100MG/ML)INJECTABLE / INTRAVENOUSAP2012-04-06782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202869-001LEVETIRACETAM500MG/5ML (100MG/ML)INJECTABLE / INTRAVENOUSAP2012-04-0687673890dc5c…
2021-03-12 10:30 UTC2021-03A202869-001LEVETIRACETAM500MG/5ML (100MG/ML)INJECTABLE / INTRAVENOUSAP2012-04-065aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202869-001LEVETIRACETAM500MG/5ML (100MG/ML)INJECTABLE / INTRAVENOUSAP2012-04-068869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202869-001LEVETIRACETAM500MG/5ML (100MG/ML)INJECTABLE / INTRAVENOUSAP2012-04-06c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202869-001LEVETIRACETAM500MG/5ML (100MG/ML)INJECTABLE / INTRAVENOUSAP2012-04-063f01610625f2…
2019-09-15 20:21 UTC2019-09A202869-001LEVETIRACETAM500MG/5ML (100MG/ML)INJECTABLE / INTRAVENOUSAP2012-04-06b00525d2431f…
2019-07-19 19:46 UTC2019-07A202869-001LEVETIRACETAM500MG/5ML (100MG/ML)INJECTABLE / INTRAVENOUSAP2012-04-06ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202869-001LEVETIRACETAM500MG/5ML (100MG/ML)INJECTABLE / INTRAVENOUSAP2012-04-066a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A202869-001LEVETIRACETAM500MG/5ML (100MG/ML)INJECTABLE / INTRAVENOUSAP2012-04-061c564ffb4f44…
2023-12-20 04:57 UTC2023-12A202869-001LEVETIRACETAM500MG/5ML (100MG/ML)INJECTABLE / INTRAVENOUSAP2012-04-06ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202869-001LEVETIRACETAM500MG/5ML (100MG/ML)INJECTABLE / INTRAVENOUSAP2012-04-06a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202869-001LEVETIRACETAM500MG/5ML (100MG/ML)INJECTABLE / INTRAVENOUSAP2012-04-069b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202869-001LEVETIRACETAM500MG/5ML (100MG/ML)INJECTABLE / INTRAVENOUSAP2012-04-06a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A202869-001LEVETIRACETAM500MG/5ML (100MG/ML)INJECTABLE / INTRAVENOUSAP2012-04-063f0d92c62455…
2023-05-13 08:27 UTC2023-05A202869-001LEVETIRACETAM500MG/5ML (100MG/ML)INJECTABLE / INTRAVENOUSAP2012-04-06053a50430f4f…
2023-01-26 05:58 UTC2023-01A202869-001LEVETIRACETAM500MG/5ML (100MG/ML)INJECTABLE / INTRAVENOUSAP2012-04-063bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A202869-001LEVETIRACETAM500MG/5ML (100MG/ML)INJECTABLE / INTRAVENOUSAP2012-04-063a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A202869-001LEVETIRACETAM500MG/5ML (100MG/ML)INJECTABLE / INTRAVENOUSAP2012-04-06f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A202869-001LEVETIRACETAM500MG/5ML (100MG/ML)INJECTABLE / INTRAVENOUSAP2012-04-06e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A202869-001LEVETIRACETAM500MG/5ML (100MG/ML)INJECTABLE / INTRAVENOUSAP2012-04-06cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A202869-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202869-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202869-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202869-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202869-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202869-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202869-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202869-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202869-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202869-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202869-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202869-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202869-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202869-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202869-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202869-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202869-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202869-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202869-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202869-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202869-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A202869-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202869-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202869-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202869-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A202869-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A202869-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202869-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A202869-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A202869-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202869-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202869-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202869-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A202869-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A202869-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A202869-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A202869-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A202869-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A202869-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A202869-001AP1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
LEVETIRACETAM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVETIRACETAM100 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
647121Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ed1b74a8-2a9b-4315-b051-673c7941cb13Available 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
0409-1886-02LEVETIRACETAM25 in 1 CARTONINJECTION, SOLUTION2523
0409-1886-22LEVETIRACETAM5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION523

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-1886-02ML - Milliliter0409-18869b2a7b06-8c19-4e28-8857-01f16a7bf40c12013-02-13
0409-1886-05ML - Milliliter0409-188644e8bac9-346a-4cfd-bf38-d454745e753812018-03-08
0409-1886-15ML - Milliliter0409-1886d2d865df-e712-46d0-800e-96fc149edb2812018-03-08
0409-1886-22ML - Milliliter0409-18861e9301cf-122a-48d0-bfff-4439e01a4be312017-07-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVETIRACETAMACTIVE INGREDIENT44YRR34555LEVETIRACETAM INJECTION [HOSPIRA, INC.]4
LEVETIRACETAMACTIVE MOIETY44YRR34555LEVETIRACETAM INJECTION [HOSPIRA, INC.]4
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063PLEVETIRACETAM INJECTION [HOSPIRA, INC.]4
SODIUM ACETATEINACTIVE INGREDIENT4550K0SC9BLEVETIRACETAM INJECTION [HOSPIRA, INC.]4
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XLEVETIRACETAM INJECTION [HOSPIRA, INC.]4
WATERINACTIVE INGREDIENT059QF0KO0RLEVETIRACETAM INJECTION [HOSPIRA, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-1886LEVETIRACETAM INJECTION, SOLUTION [HOSPIRA, INC.]23Current NDC, Legacy NDC, 2 package rows20240601_ed1b74a8-2a9b-4315-b051-673c7941cb13.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LEVETIRACETAMLEVETIRACETAMHospira, Inc.f1935bc8-30ce-4b51-8a4c-0f12ce9000a62024-06-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202869
application number: ANDA202869
LEVETIRACETAMLEVETIRACETAMHospira, Inc.ed1b74a8-2a9b-4315-b051-673c7941cb132024-05-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202869
application number: ANDA202869
ndc (product): 0409-1886

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
647121levETIRAcetam 500 MG in 5 ML InjectionPSNed1b74a8-2a9b-4315-b051-673c7941cb1323
6471215 ML levetiracetam 100 MG/ML InjectionSCDed1b74a8-2a9b-4315-b051-673c7941cb1323
647121levetiracetam 500 MG per 5 ML InjectionSYed1b74a8-2a9b-4315-b051-673c7941cb1323

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0409-1886-050040918860525 VIAL, SINGLE-DOSE in 1 CARTON (0409-1886-05) > 5 mL in 1 VIAL, SINGLE-DOSE (0409-1886-15) 2018-03-010000-00-00NoNoCurrent