Home NDC 51991-651-16 LEVETIRACETAM
Product NDC 51991-651
Requested package NDC 51991-651-16
11-digit product format 519910651
Labeler code 51991
Product ID 51991-651_9e6c00bc-2eaf-4cd8-be6b-3a5506acfa6b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name LEVETIRACETAM
Dosage form SOLUTION
Route ORAL
Labeler Breckenridge Pharmaceutical, Inc.
Application ANDA079120
Marketing category ANDA
Marketing start 2013-11-19
Marketing end 2024-12-31
Substance LEVETIRACETAM
Active strength 100 mg/mL
Pharmacologic classes Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record 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 A079120-001 LEVETIRACETAM LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A079120-001 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.
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 2026-08-01 22:54:32 2026-06 A079120-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-16 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A079120-001 AA 1 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Levetiracetam ACTIVE INGREDIENT 44YRR34555 LEVETIRACETAM SOLUTION [BRECKENRIDGE PHARMACEUTICAL, INC.] 5 Levetiracetam ACTIVE MOIETY 44YRR34555 LEVETIRACETAM SOLUTION [BRECKENRIDGE PHARMACEUTICAL, INC.] 5 acesulfame potassium INACTIVE INGREDIENT 23OV73Q5G9 LEVETIRACETAM SOLUTION [BRECKENRIDGE PHARMACEUTICAL, INC.] 5 ammonium glycyrrhizate INACTIVE INGREDIENT 3VRD35U26C LEVETIRACETAM SOLUTION [BRECKENRIDGE PHARMACEUTICAL, INC.] 5 anhydrous citric acid INACTIVE INGREDIENT XF417D3PSL LEVETIRACETAM SOLUTION [BRECKENRIDGE PHARMACEUTICAL, INC.] 5 glycerin INACTIVE INGREDIENT PDC6A3C0OX LEVETIRACETAM SOLUTION [BRECKENRIDGE PHARMACEUTICAL, INC.] 5 grape INACTIVE INGREDIENT 6X543N684K LEVETIRACETAM SOLUTION [BRECKENRIDGE PHARMACEUTICAL, INC.] 5 maltitol INACTIVE INGREDIENT D65DG142WK LEVETIRACETAM SOLUTION [BRECKENRIDGE PHARMACEUTICAL, INC.] 5 methylparaben INACTIVE INGREDIENT A2I8C7HI9T LEVETIRACETAM SOLUTION [BRECKENRIDGE PHARMACEUTICAL, INC.] 5 propylparaben INACTIVE INGREDIENT Z8IX2SC1OH LEVETIRACETAM SOLUTION [BRECKENRIDGE PHARMACEUTICAL, INC.] 5 trisodium citrate dihydrate INACTIVE INGREDIENT B22547B95K LEVETIRACETAM SOLUTION [BRECKENRIDGE PHARMACEUTICAL, INC.] 5 water INACTIVE INGREDIENT 059QF0KO0R LEVETIRACETAM SOLUTION [BRECKENRIDGE PHARMACEUTICAL, INC.] 5
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 51991-651-16 51991065116 473 mL in 1 BOTTLE (51991-651-16) 473 ml 2013-11-19 2024-12-31 No No Current