spritam

Generic: levetiracetam

Labeler: aprecia pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name spritam
Generic Name levetiracetam
Labeler aprecia pharmaceuticals, llc
Dosage Form TABLET, FOR SUSPENSION
Routes
ORAL
Active Ingredients

levetiracetam 1000 mg/1

Manufacturer
Aprecia Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 43485-104
Product ID 43485-104_890ef534-7363-4f2b-b125-8f62e2eb26d0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA207958
Marketing Start 2016-02-05
Marketing End 2028-06-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43485104
Hyphenated Format 43485-104

Supplemental Identifiers

RxCUI
1736037 1736044 1736045 1736047 1736048 1736050 1736051 1736053
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 spritam (source: ndc)
Generic Name levetiracetam (source: ndc)
Application Number NDA207958 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1000 mg/1
source: ndc
Packaging
  • 60 BLISTER PACK in 1 CARTON (43485-104-60) / 1 TABLET, FOR SUSPENSION in 1 BLISTER PACK (43485-104-01)
source: ndc

Packages (1)

43485-104-60 60 BLISTER PACK in 1 CARTON (43485-104-60) / 1 TABLET, FOR SUSPENSION in 1 BLISTER PACK (43485-104-01)

Ingredients (1)

levetiracetam (1000 mg/1)

Linked Drug Pages (1)

Spritam ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "890ef534-7363-4f2b-b125-8f62e2eb26d0", "openfda": {"nui": ["N0000008486"], "unii": ["44YRR34555"], "rxcui": ["1736037", "1736044", "1736045", "1736047", "1736048", "1736050", "1736051", "1736053"], "spl_set_id": ["be651c31-383f-11e4-916c-0800200c9a66"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Aprecia Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 BLISTER PACK in 1 CARTON (43485-104-60)  / 1 TABLET, FOR SUSPENSION in 1 BLISTER PACK (43485-104-01)", "package_ndc": "43485-104-60", "marketing_end_date": "20280630", "marketing_start_date": "20160205"}], "brand_name": "Spritam", "product_id": "43485-104_890ef534-7363-4f2b-b125-8f62e2eb26d0", "dosage_form": "TABLET, FOR SUSPENSION", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "43485-104", "generic_name": "levetiracetam", "labeler_name": "Aprecia Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Spritam", "active_ingredients": [{"name": "LEVETIRACETAM", "strength": "1000 mg/1"}], "application_number": "NDA207958", "marketing_category": "NDA", "marketing_end_date": "20280630", "marketing_start_date": "20160205"}