levetiracetam

Generic: levetiracetam

Labeler: mckesson corporation dba sky packaging
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levetiracetam
Generic Name levetiracetam
Labeler mckesson corporation dba sky packaging
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

levetiracetam 100 mg/mL

Manufacturer
McKesson Corporation dba SKY Packaging

Identifiers & Regulatory

Product NDC 63739-158
Product ID 63739-158_cfa2687a-92d1-4da7-ae11-c1e322bd8176
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201157
Marketing Start 2022-07-01
Marketing End 2026-06-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63739158
Hyphenated Format 63739-158

Supplemental Identifiers

RxCUI
403884
UNII
44YRR34555
NUI
N0000008486

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 ANDA201157 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/mL
source: ndc
Packaging
  • 4 TRAY in 1 CASE (63739-158-32) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (63739-158-70)
  • 3 TRAY in 1 CASE (63739-158-78) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (63739-158-70)
source: ndc

Packages (2)

63739-158-32 4 TRAY in 1 CASE (63739-158-32) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (63739-158-70) 63739-158-78 3 TRAY in 1 CASE (63739-158-78) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (63739-158-70)

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": "cfa2687a-92d1-4da7-ae11-c1e322bd8176", "openfda": {"nui": ["N0000008486"], "unii": ["44YRR34555"], "rxcui": ["403884"], "spl_set_id": ["7a0d7f05-e091-4d9b-93f5-fd2c7f728a83"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["McKesson Corporation dba SKY Packaging"]}, "finished": true, "packaging": [{"sample": false, "description": "4 TRAY in 1 CASE (63739-158-32)  / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (63739-158-70)", "package_ndc": "63739-158-32", "marketing_end_date": "20260630", "marketing_start_date": "20220701"}, {"sample": false, "description": "3 TRAY in 1 CASE (63739-158-78)  / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (63739-158-70)", "package_ndc": "63739-158-78", "marketing_end_date": "20260630", "marketing_start_date": "20230501"}], "brand_name": "Levetiracetam", "product_id": "63739-158_cfa2687a-92d1-4da7-ae11-c1e322bd8176", "dosage_form": "SOLUTION", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "63739-158", "generic_name": "Levetiracetam", "labeler_name": "McKesson Corporation dba SKY Packaging", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levetiracetam", "active_ingredients": [{"name": "LEVETIRACETAM", "strength": "100 mg/mL"}], "application_number": "ANDA201157", "marketing_category": "ANDA", "marketing_end_date": "20260630", "marketing_start_date": "20220701"}