levetiracetam

Generic: levetiracetam

Labeler: quagen pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levetiracetam
Generic Name levetiracetam
Labeler quagen pharmaceuticals llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

levetiracetam 100 mg/mL

Manufacturer
QUAGEN PHARMACEUTICALS LLC

Identifiers & Regulatory

Product NDC 70752-203
Product ID 70752-203_339d66da-457a-4267-806b-7673122db283
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090079
Listing Expiration 2026-12-31
Marketing Start 2025-02-01

Pharmacologic Class

Physiologic Effect
decreased central nervous system disorganized electrical activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70752203
Hyphenated Format 70752-203

Supplemental Identifiers

RxCUI
403884
UPC
0370752203128
UNII
44YRR34555
NUI
N0000008486

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name levetiracetam (source: ndc)
Generic Name levetiracetam (source: ndc)
Application Number ANDA090079 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/mL
source: ndc
Packaging
  • 10 CUP, UNIT-DOSE in 1 TRAY (70752-203-02) / 15 mL in 1 CUP, UNIT-DOSE
  • 473 mL in 1 BOTTLE (70752-203-12)
  • 10 CUP, UNIT-DOSE in 1 TRAY (70752-203-16) / 5 mL in 1 CUP, UNIT-DOSE
  • 10 CUP, UNIT-DOSE in 1 TRAY (70752-203-27) / 10 mL in 1 CUP, UNIT-DOSE
source: ndc

Packages (4)

70752-203-02 10 CUP, UNIT-DOSE in 1 TRAY (70752-203-02) / 15 mL in 1 CUP, UNIT-DOSE 70752-203-12 473 mL in 1 BOTTLE (70752-203-12) 70752-203-16 10 CUP, UNIT-DOSE in 1 TRAY (70752-203-16) / 5 mL in 1 CUP, UNIT-DOSE 70752-203-27 10 CUP, UNIT-DOSE in 1 TRAY (70752-203-27) / 10 mL in 1 CUP, UNIT-DOSE

Ingredients (1)

levetiracetam (100 mg/mL)

Linked Drug Pages (1)

LEVETIRACETAM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "339d66da-457a-4267-806b-7673122db283", "openfda": {"nui": ["N0000008486"], "upc": ["0370752203128"], "unii": ["44YRR34555"], "rxcui": ["403884"], "spl_set_id": ["1d67cb3c-1173-4dce-a79b-a3c36934ab2e"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["QUAGEN PHARMACEUTICALS LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 CUP, UNIT-DOSE in 1 TRAY (70752-203-02)  / 15 mL in 1 CUP, UNIT-DOSE", "package_ndc": "70752-203-02", "marketing_start_date": "20250201"}, {"sample": false, "description": "473 mL in 1 BOTTLE (70752-203-12)", "package_ndc": "70752-203-12", "marketing_start_date": "20250201"}, {"sample": false, "description": "10 CUP, UNIT-DOSE in 1 TRAY (70752-203-16)  / 5 mL in 1 CUP, UNIT-DOSE", "package_ndc": "70752-203-16", "marketing_start_date": "20250201"}, {"sample": false, "description": "10 CUP, UNIT-DOSE in 1 TRAY (70752-203-27)  / 10 mL in 1 CUP, UNIT-DOSE", "package_ndc": "70752-203-27", "marketing_start_date": "20250201"}], "brand_name": "LEVETIRACETAM", "product_id": "70752-203_339d66da-457a-4267-806b-7673122db283", "dosage_form": "SOLUTION", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "70752-203", "generic_name": "LEVETIRACETAM", "labeler_name": "QUAGEN PHARMACEUTICALS LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LEVETIRACETAM", "active_ingredients": [{"name": "LEVETIRACETAM", "strength": "100 mg/mL"}], "application_number": "ANDA090079", "marketing_category": "ANDA", "marketing_start_date": "20250201", "listing_expiration_date": "20261231"}