asenapine

Generic: asenapine maleate

Labeler: breckenridge pharmaceutical, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name asenapine
Generic Name asenapine maleate
Labeler breckenridge pharmaceutical, inc.
Dosage Form TABLET
Routes
SUBLINGUAL
Active Ingredients

asenapine maleate 10 mg/1

Manufacturer
Breckenridge Pharmaceutical, Inc.

Identifiers & Regulatory

Product NDC 51991-361
Product ID 51991-361_b48a6c73-5ff9-46da-ae10-6fc0ced6afc7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205960
Listing Expiration 2026-12-31
Marketing Start 2020-12-10

Pharmacologic Class

Classes
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 51991361
Hyphenated Format 51991-361

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
  • 10 BLISTER PACK in 1 BOX (51991-361-11) / 10 TABLET in 1 BLISTER PACK (51991-361-99)
  • 6 BLISTER PACK in 1 BOX (51991-361-60) / 10 TABLET in 1 BLISTER PACK
source: ndc

Packages (2)

51991-361-11 10 BLISTER PACK in 1 BOX (51991-361-11) / 10 TABLET in 1 BLISTER PACK (51991-361-99) 51991-361-60 6 BLISTER PACK in 1 BOX (51991-361-60) / 10 TABLET in 1 BLISTER PACK

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": "b48a6c73-5ff9-46da-ae10-6fc0ced6afc7", "openfda": {"unii": ["CU9463U2E2"], "rxcui": ["859975", "859981", "1606337"], "spl_set_id": ["f5cd9abb-40e3-4cb5-a1b2-40cdba8a1c7e"], "manufacturer_name": ["Breckenridge Pharmaceutical, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 BOX (51991-361-11)  / 10 TABLET in 1 BLISTER PACK (51991-361-99)", "package_ndc": "51991-361-11", "marketing_start_date": "20201210"}, {"sample": false, "description": "6 BLISTER PACK in 1 BOX (51991-361-60)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "51991-361-60", "marketing_start_date": "20201210"}], "brand_name": "Asenapine", "product_id": "51991-361_b48a6c73-5ff9-46da-ae10-6fc0ced6afc7", "dosage_form": "TABLET", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "51991-361", "generic_name": "ASENAPINE MALEATE", "labeler_name": "Breckenridge Pharmaceutical, Inc.", "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": "20201210", "listing_expiration_date": "20261231"}