asenapine

Generic: asenapine maleate

Labeler: msn laboratories private limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name asenapine
Generic Name asenapine maleate
Labeler msn laboratories private limited
Dosage Form TABLET
Routes
SUBLINGUAL
Active Ingredients

asenapine maleate 10 mg/1

Manufacturer
MSN LABORATORIES PRIVATE LIMITED

Identifiers & Regulatory

Product NDC 69539-060
Product ID 69539-060_0c0d566e-5315-4e29-a207-5f2eb75910f0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205960
Listing Expiration 2026-12-31
Marketing Start 2021-08-27

Pharmacologic Class

Classes
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69539060
Hyphenated Format 69539-060

Supplemental Identifiers

RxCUI
859975 859981 1606337
UNII
CU9463U2E2

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 asenapine (source: ndc)
Generic Name asenapine maleate (source: ndc)
Application Number ANDA205960 (source: ndc)
Routes
SUBLINGUAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 60 TABLET in 1 BOX (69539-060-34)
source: ndc

Packages (1)

69539-060-34 60 TABLET in 1 BOX (69539-060-34)

Ingredients (1)

asenapine maleate (10 mg/1)

Linked Drug Pages (1)

Asenapine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBLINGUAL"], "spl_id": "0c0d566e-5315-4e29-a207-5f2eb75910f0", "openfda": {"unii": ["CU9463U2E2"], "rxcui": ["859975", "859981", "1606337"], "spl_set_id": ["4c7a1b17-e73e-4417-a172-bfb03569d7ff"], "manufacturer_name": ["MSN LABORATORIES PRIVATE LIMITED"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET in 1 BOX (69539-060-34)", "package_ndc": "69539-060-34", "marketing_start_date": "20210827"}], "brand_name": "Asenapine", "product_id": "69539-060_0c0d566e-5315-4e29-a207-5f2eb75910f0", "dosage_form": "TABLET", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "69539-060", "generic_name": "ASENAPINE MALEATE", "labeler_name": "MSN LABORATORIES PRIVATE LIMITED", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Asenapine", "active_ingredients": [{"name": "ASENAPINE MALEATE", "strength": "10 mg/1"}], "application_number": "ANDA205960", "marketing_category": "ANDA", "marketing_start_date": "20210827", "listing_expiration_date": "20261231"}