Levetiracetam

Product NDC
14335-050
11-digit product format
143350050
Labeler code
14335
Product ID
14335-050_7bcb0387-53da-281d-e053-2991aa0ac67b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levetiracetam
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
Hainan Poly Pharm. Co., Ltd.
Application
ANDA209781
Marketing category
ANDA
Marketing start
2018-11-30
Marketing end
0000-00-00
Substance
LEVETIRACETAM
Active strength
100 mg/mL
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct14335-050IInactivated by FDA2026-08-11
excluded packagepackage14335-05014335-050-10IInactivated by FDA2026-08-11
excluded packagepackage14335-05014335-050-25IInactivated by FDA2026-08-11

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 2 · 63 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage14335-050-25d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage14335-050-10d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage14335-050-25f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage14335-050-10f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage14335-050-252ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage14335-050-102ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage14335-050-25a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage14335-050-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage14335-050-25cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage14335-050-10cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage14335-050-25cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage14335-050-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage14335-050-25302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage14335-050-10302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage14335-050-25ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage14335-050-10ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage14335-050-250efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage14335-050-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage14335-050-25ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage14335-050-10ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage14335-050-25367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage14335-050-10367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage14335-050-25557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage14335-050-10557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage14335-050-258af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage14335-050-108af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage14335-050-25834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage14335-050-10834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage14335-050-251332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage14335-050-101332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage14335-050-10fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage14335-050-25fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage14335-050-1086f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage14335-050-2586f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage14335-050-10bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage14335-050-25bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage14335-050-108dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage14335-050-258dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage14335-050-10e2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage14335-050-25e2bbac7714bc…27bdfed8d636…

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
A209781-001LEVETIRACETAMLEVETIRACETAM500MG/5ML (100MG/ML)INJECTABLE / INTRAVENOUSAP2018-03-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A209781-001AP

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 UTC2026-02A209781-001LEVETIRACETAM500MG/5ML (100MG/ML)INJECTABLE / INTRAVENOUSAP2018-03-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209781-001LEVETIRACETAM500MG/5ML (100MG/ML)INJECTABLE / INTRAVENOUSAP2018-03-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A209781-001LEVETIRACETAM500MG/5ML (100MG/ML)INJECTABLE / INTRAVENOUSAP2018-03-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209781-001LEVETIRACETAM500MG/5ML (100MG/ML)INJECTABLE / INTRAVENOUSAP2018-03-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209781-001LEVETIRACETAM500MG/5ML (100MG/ML)INJECTABLE / INTRAVENOUSAP2018-03-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209781-001LEVETIRACETAM500MG/5ML (100MG/ML)INJECTABLE / INTRAVENOUSAP2018-03-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209781-001LEVETIRACETAM500MG/5ML (100MG/ML)INJECTABLE / INTRAVENOUSAP2018-03-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209781-001LEVETIRACETAM500MG/5ML (100MG/ML)INJECTABLE / INTRAVENOUSAP2018-03-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209781-001LEVETIRACETAM500MG/5ML (100MG/ML)INJECTABLE / INTRAVENOUSAP2018-03-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209781-001LEVETIRACETAM500MG/5ML (100MG/ML)INJECTABLE / INTRAVENOUSAP2018-03-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209781-001LEVETIRACETAM500MG/5ML (100MG/ML)INJECTABLE / INTRAVENOUSAP2018-03-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209781-001LEVETIRACETAM500MG/5ML (100MG/ML)INJECTABLE / INTRAVENOUSAP2018-03-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209781-001LEVETIRACETAM500MG/5ML (100MG/ML)INJECTABLE / INTRAVENOUSAP2018-03-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209781-001LEVETIRACETAM500MG/5ML (100MG/ML)INJECTABLE / INTRAVENOUSAP2018-03-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209781-001LEVETIRACETAM500MG/5ML (100MG/ML)INJECTABLE / INTRAVENOUSAP2018-03-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209781-001LEVETIRACETAM500MG/5ML (100MG/ML)INJECTABLE / INTRAVENOUSAP2018-03-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209781-001LEVETIRACETAM500MG/5ML (100MG/ML)INJECTABLE / INTRAVENOUSAP2018-03-204b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209781-001LEVETIRACETAM500MG/5ML (100MG/ML)INJECTABLE / INTRAVENOUSAP2018-03-2074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A209781-001LEVETIRACETAM500MG/5ML (100MG/ML)INJECTABLE / INTRAVENOUSAP2018-03-20bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A209781-001LEVETIRACETAM500MG/5ML (100MG/ML)INJECTABLE / INTRAVENOUSAP2018-03-20782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A209781-001LEVETIRACETAM500MG/5ML (100MG/ML)INJECTABLE / INTRAVENOUSAP2018-03-2087673890dc5c…
2021-03-12 10:30 UTC2021-03A209781-001LEVETIRACETAM500MG/5ML (100MG/ML)INJECTABLE / INTRAVENOUSAP2018-03-205aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A209781-001LEVETIRACETAM500MG/5ML (100MG/ML)INJECTABLE / INTRAVENOUSAP2018-03-208869cabd3fbd…
2020-11-12 02:37 UTC2020-11A209781-001LEVETIRACETAM500MG/5ML (100MG/ML)INJECTABLE / INTRAVENOUSAP2018-03-20c0c555d07b60…
2019-12-14 00:12 UTC2019-12A209781-001LEVETIRACETAM500MG/5ML (100MG/ML)INJECTABLE / INTRAVENOUSAP2018-03-203f01610625f2…
2019-09-15 20:21 UTC2019-09A209781-001LEVETIRACETAM500MG/5ML (100MG/ML)INJECTABLE / INTRAVENOUSAP2018-03-20b00525d2431f…
2019-07-19 19:46 UTC2019-07A209781-001LEVETIRACETAM500MG/5ML (100MG/ML)INJECTABLE / INTRAVENOUSAP2018-03-20ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A209781-001LEVETIRACETAM500MG/5ML (100MG/ML)INJECTABLE / INTRAVENOUSAP2018-03-206a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A209781-001LEVETIRACETAM500MG/5ML (100MG/ML)INJECTABLE / INTRAVENOUSAP2018-03-201c564ffb4f44…
2023-12-20 04:57 UTC2023-12A209781-001LEVETIRACETAM500MG/5ML (100MG/ML)INJECTABLE / INTRAVENOUSAP2018-03-20ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A209781-001LEVETIRACETAM500MG/5ML (100MG/ML)INJECTABLE / INTRAVENOUSAP2018-03-20a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A209781-001LEVETIRACETAM500MG/5ML (100MG/ML)INJECTABLE / INTRAVENOUSAP2018-03-209b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A209781-001LEVETIRACETAM500MG/5ML (100MG/ML)INJECTABLE / INTRAVENOUSAP2018-03-20a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A209781-001LEVETIRACETAM500MG/5ML (100MG/ML)INJECTABLE / INTRAVENOUSAP2018-03-203f0d92c62455…
2023-05-13 08:27 UTC2023-05A209781-001LEVETIRACETAM500MG/5ML (100MG/ML)INJECTABLE / INTRAVENOUSAP2018-03-20053a50430f4f…
2023-01-26 05:58 UTC2023-01A209781-001LEVETIRACETAM500MG/5ML (100MG/ML)INJECTABLE / INTRAVENOUSAP2018-03-203bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A209781-001LEVETIRACETAM500MG/5ML (100MG/ML)INJECTABLE / INTRAVENOUSAP2018-03-203a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A209781-001LEVETIRACETAM500MG/5ML (100MG/ML)INJECTABLE / INTRAVENOUSAP2018-03-20f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A209781-001LEVETIRACETAM500MG/5ML (100MG/ML)INJECTABLE / INTRAVENOUSAP2018-03-20e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A209781-001LEVETIRACETAM500MG/5ML (100MG/ML)INJECTABLE / INTRAVENOUSAP2018-03-20cb3db0bc1861…

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 UTC2026-02A209781-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209781-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209781-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209781-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209781-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209781-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209781-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209781-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209781-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209781-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209781-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209781-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209781-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209781-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209781-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209781-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209781-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209781-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A209781-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A209781-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A209781-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A209781-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A209781-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A209781-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A209781-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A209781-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A209781-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A209781-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A209781-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A209781-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A209781-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A209781-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A209781-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A209781-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A209781-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A209781-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A209781-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A209781-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A209781-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A209781-001AP1cb3db0bc1861…

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
14335-050-10Levetiracetam10 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE103
14335-050-10Levetiracetam5 mL in 1 VIAL, SINGLE-USEINJECTION, SOLUTION, CONCENTRATE53
14335-050-25Levetiracetam5 mL in 1 VIAL, SINGLE-USEINJECTION, SOLUTION, CONCENTRATE53
14335-050-25Levetiracetam25 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE253

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
14335-050LEVETIRACETAM INJECTION, SOLUTION, CONCENTRATE [HAINAN POLY PHARM. CO., LTD.]3Legacy NDC, 4 package rows20181130_80019d2e-4aec-41f0-ab91-03ca9ffd798d.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LEVETIRACETAMLEVETIRACETAMMethod Pharmaceuticals, LLC47cfe577-b4cb-d35e-e063-6394a90ad8c42025-12-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209781
application number: ANDA209781
LevetiracetamLEVETIRACETAMTAGI Pharma, Inc.72f7ddd9-1b2c-4e26-8060-20e10c1c5d1c2025-11-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209781
application number: ANDA209781
LevetiracetamLEVETIRACETAMPrecision Dose, Inc.6fb1e4d3-520c-44f1-a09d-d7b779e4edfd2025-09-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209781
application number: ANDA209781

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
647121levETIRAcetam 500 MG in 5 ML InjectionPSN80019d2e-4aec-41f0-ab91-03ca9ffd798d3
6471215 ML levetiracetam 100 MG/ML InjectionSCD80019d2e-4aec-41f0-ab91-03ca9ffd798d3
647121levetiracetam 500 MG per 5 ML InjectionSY80019d2e-4aec-41f0-ab91-03ca9ffd798d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
14335-050-101433500501010 in 1 CARTONHistorical
14335-050-25143350050255 mL in 1 VIAL, SINGLE-USE5 mlHistorical