Home NDC 66689-102-20 Levetiracetam
Product NDC 66689-102
Requested package NDC 66689-102-20
11-digit product format 666890102
Labeler code 66689
Product ID 66689-102_c0232b95-ecd0-413d-a8ea-e6721aa21fdd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Levetiracetam
Dosage form SOLUTION
Route ORAL
Labeler VistaPharm, LLC
Application ANDA078976
Marketing category ANDA
Marketing start 2021-02-24
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 2023-12-31
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 A078976-001 LEVETIRACETAM LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A078976-001 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 A078976-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 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 A078976-001 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 · 1 matching rows.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Levetiracetam ACTIVE INGREDIENT 44YRR34555 LEVETIRACETAM SOLUTION [VISTAPHARM, INC] 2 Levetiracetam ACTIVE MOIETY 44YRR34555 LEVETIRACETAM SOLUTION [VISTAPHARM, INC] 2 acesulfame potassium INACTIVE INGREDIENT 23OV73Q5G9 LEVETIRACETAM SOLUTION [VISTAPHARM, INC] 2 citric acid monohydrate INACTIVE INGREDIENT 2968PHW8QP LEVETIRACETAM SOLUTION [VISTAPHARM, INC] 2 glycerin INACTIVE INGREDIENT PDC6A3C0OX LEVETIRACETAM SOLUTION [VISTAPHARM, INC] 2 glycyrrhizin, ammoniated INACTIVE INGREDIENT 3VRD35U26C LEVETIRACETAM SOLUTION [VISTAPHARM, INC] 2 maltitol INACTIVE INGREDIENT D65DG142WK LEVETIRACETAM SOLUTION [VISTAPHARM, INC] 2 methylparaben INACTIVE INGREDIENT A2I8C7HI9T LEVETIRACETAM SOLUTION [VISTAPHARM, INC] 2 propylparaben INACTIVE INGREDIENT Z8IX2SC1OH LEVETIRACETAM SOLUTION [VISTAPHARM, INC] 2 trisodium citrate dihydrate INACTIVE INGREDIENT B22547B95K LEVETIRACETAM SOLUTION [VISTAPHARM, INC] 2 water INACTIVE INGREDIENT 059QF0KO0R LEVETIRACETAM SOLUTION [VISTAPHARM, INC] 2
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 66689-102-20 66689010220 2 TRAY in 1 CASE (66689-102-20) > 10 CUP, UNIT-DOSE in 1 TRAY > 10 mL in 1 CUP, UNIT-DOSE (66689-102-01) 2 tray 2021-02-24 0000-00-00 No No Current