Home NDC 31722-574-47 Levetiracetam
Product NDC 31722-574
Requested package NDC 31722-574-47
11-digit product format 317220574
Labeler code 31722
Product ID 31722-574_230b2750-8691-425b-9fe3-176b46e01e78
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Levetiracetam oral
Dosage form SOLUTION
Route ORAL
Labeler Camber Pharmaceuticals, Inc.
Application ANDA203052
Marketing category ANDA
Marketing start 2015-06-11
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 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 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 31722-574 31722-574-47 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip 367a005e9d99…383a685ebd0f…
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A203052-001 LEVETIRACETAM LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2013-02-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A203052-001 AA
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A203052-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2013-02-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203052-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2013-02-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203052-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2013-02-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203052-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2013-02-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203052-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2013-02-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203052-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2013-02-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203052-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2013-02-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203052-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2013-02-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203052-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2013-02-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203052-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2013-02-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203052-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2013-02-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203052-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2013-02-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203052-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2013-02-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203052-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2013-02-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203052-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2013-02-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203052-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2013-02-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203052-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2013-02-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203052-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2013-02-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203052-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2013-02-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203052-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2013-02-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A203052-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2013-02-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A203052-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2013-02-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A203052-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2013-02-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A203052-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2013-02-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A203052-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2013-02-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A203052-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2013-02-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A203052-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2013-02-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A203052-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2013-02-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A203052-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2013-02-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A203052-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2013-02-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A203052-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2013-02-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A203052-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2013-02-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A203052-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2013-02-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A203052-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2013-02-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A203052-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2013-02-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A203052-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2013-02-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A203052-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2013-02-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A203052-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2013-02-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A203052-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2013-02-28 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A203052-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2013-02-28 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Levetiracetam
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LEVETIRACETAM 100 mg/mL
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 403884 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 31722-574-47 Levetiracetam 473 mL in 1 BOTTLE SOLUTION 473 10
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded LEVETIRACETAM ACTIVE INGREDIENT 44YRR34555 LEVETIRACETAM LEVETIRACETAM (LEVETIRACETAM) SOLUTION [CAMBER PHARMACEUTICALS, INC.] 3 LEVETIRACETAM ACTIVE MOIETY 44YRR34555 LEVETIRACETAM LEVETIRACETAM (LEVETIRACETAM) SOLUTION [CAMBER PHARMACEUTICALS, INC.] 3 ACESULFAME POTASSIUM INACTIVE INGREDIENT 23OV73Q5G9 LEVETIRACETAM LEVETIRACETAM (LEVETIRACETAM) SOLUTION [CAMBER PHARMACEUTICALS, INC.] 3 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP LEVETIRACETAM LEVETIRACETAM (LEVETIRACETAM) SOLUTION [CAMBER PHARMACEUTICALS, INC.] 3 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX LEVETIRACETAM LEVETIRACETAM (LEVETIRACETAM) SOLUTION [CAMBER PHARMACEUTICALS, INC.] 3 GLYCYRRHIZIN, AMMONIATED INACTIVE INGREDIENT 3VRD35U26C LEVETIRACETAM LEVETIRACETAM (LEVETIRACETAM) SOLUTION [CAMBER PHARMACEUTICALS, INC.] 3 MALTITOL INACTIVE INGREDIENT D65DG142WK LEVETIRACETAM LEVETIRACETAM (LEVETIRACETAM) SOLUTION [CAMBER PHARMACEUTICALS, INC.] 3 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T LEVETIRACETAM LEVETIRACETAM (LEVETIRACETAM) SOLUTION [CAMBER PHARMACEUTICALS, INC.] 3 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH LEVETIRACETAM LEVETIRACETAM (LEVETIRACETAM) SOLUTION [CAMBER PHARMACEUTICALS, INC.] 3 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR LEVETIRACETAM LEVETIRACETAM (LEVETIRACETAM) SOLUTION [CAMBER PHARMACEUTICALS, INC.] 3 WATER INACTIVE INGREDIENT 059QF0KO0R LEVETIRACETAM LEVETIRACETAM (LEVETIRACETAM) SOLUTION [CAMBER PHARMACEUTICALS, INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 31722-574 LEVETIRACETAM (LEVETIRACETAM ORAL) SOLUTION [CAMBER PHARMACEUTICALS, INC.] 10 Current NDC, Legacy NDC, 1 package rows 20241102_0bc8468f-832c-4e71-95a2-db464d4d54bc.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 · 4 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 31722-574-47 31722057447 473 mL in 1 BOTTLE (31722-574-47) 473 ml 2015-06-11 0000-00-00 No No Current