pimavanserin

Generic: pimavanserin

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

Drug Facts

Product Profile

Brand Name pimavanserin
Generic Name pimavanserin
Labeler novadoz pharmaceuticals llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

pimavanserin tartrate 34 mg/1

Manufacturer
Novadoz Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 72205-055
Product ID 72205-055_403b6540-c53d-4e92-91b4-36ca6338b2b1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214925
Listing Expiration 2026-12-31
Marketing Start 2024-01-16

Pharmacologic Class

Classes
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72205055
Hyphenated Format 72205-055

Supplemental Identifiers

RxCUI
2049275
UPC
0372205055308
UNII
NA83F1SJSR

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 pimavanserin (source: ndc)
Generic Name pimavanserin (source: ndc)
Application Number ANDA214925 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 34 mg/1
source: ndc
Packaging
  • 16 HOW SUPPLIED/STORAGE AND HANDLING Pimavanserin capsules are available as: 34 mg Capsule: Size 4 HPMC capsule having light green opaque cap, printed "m" in black ink and white opaque body, printed "106" in black ink. Capsule contains White to off white powder. Bottle of 30: 72205-055-30 Storage 34 mg Capsule: Store at 20°C to 25°C (68ºF to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [See USP Controlled Room Temperature].
  • PACKAGE LABEL PRINCIPAL DISPLAY PANEL Pimavanserin capsules 34 mg-30s container label: pimavanserin-caps-34mg-30s-container-label
source: label

Packages (0)

No package records.

Ingredients (1)

pimavanserin tartrate (34 mg/1)

Linked Drug Pages (1)

pimavanserin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "403b6540-c53d-4e92-91b4-36ca6338b2b1", "openfda": {"upc": ["0372205055308"], "unii": ["NA83F1SJSR"], "rxcui": ["2049275"], "spl_set_id": ["403b6540-c53d-4e92-91b4-36ca6338b2b1"], "manufacturer_name": ["Novadoz Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [], "brand_name": "pimavanserin", "product_id": "72205-055_403b6540-c53d-4e92-91b4-36ca6338b2b1", "dosage_form": "CAPSULE", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "72205-055", "generic_name": "pimavanserin", "labeler_name": "Novadoz Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "pimavanserin", "active_ingredients": [{"name": "PIMAVANSERIN TARTRATE", "strength": "34 mg/1"}], "application_number": "ANDA214925", "marketing_category": "ANDA", "marketing_start_date": "20240116", "listing_expiration_date": "20261231"}