asenapine

Generic: asenapine

Labeler: sigmapharm laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name asenapine
Generic Name asenapine
Labeler sigmapharm laboratories, llc
Dosage Form TABLET
Routes
SUBLINGUAL
Active Ingredients

asenapine 5 mg/1

Manufacturer
Sigmapharm Laboratories, LLC

Identifiers & Regulatory

Product NDC 42794-016
Product ID 42794-016_446e6925-ccb1-e388-e063-6294a90aa5de
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206107
Listing Expiration 2026-12-31
Marketing Start 2020-12-14

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42794016
Hyphenated Format 42794-016

Supplemental Identifiers

RxCUI
859975 859981
UPC
0342794016103 0342794017100 0342794017087 0342794016226 0342794016080 0342794017223
UNII
JKZ19V908O
NUI
N0000175430

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 (source: ndc)
Application Number ANDA206107 (source: ndc)
Routes
SUBLINGUAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE, PLASTIC (42794-016-08)
  • 60 TABLET in 1 BOTTLE, PLASTIC (42794-016-10)
  • 10 TABLET in 1 BOTTLE, PLASTIC (42794-016-22)
source: ndc

Packages (3)

42794-016-08 30 TABLET in 1 BOTTLE, PLASTIC (42794-016-08) 42794-016-10 60 TABLET in 1 BOTTLE, PLASTIC (42794-016-10) 42794-016-22 10 TABLET in 1 BOTTLE, PLASTIC (42794-016-22)

Ingredients (1)

asenapine (5 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": "446e6925-ccb1-e388-e063-6294a90aa5de", "openfda": {"nui": ["N0000175430"], "upc": ["0342794016103", "0342794017100", "0342794017087", "0342794016226", "0342794016080", "0342794017223"], "unii": ["JKZ19V908O"], "rxcui": ["859975", "859981"], "spl_set_id": ["3512687b-d1c7-45c4-8822-3a2ad53575a5"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Sigmapharm Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (42794-016-08)", "package_ndc": "42794-016-08", "marketing_start_date": "20201214"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE, PLASTIC (42794-016-10)", "package_ndc": "42794-016-10", "marketing_start_date": "20201214"}, {"sample": false, "description": "10 TABLET in 1 BOTTLE, PLASTIC (42794-016-22)", "package_ndc": "42794-016-22", "marketing_start_date": "20201214"}], "brand_name": "ASENAPINE", "product_id": "42794-016_446e6925-ccb1-e388-e063-6294a90aa5de", "dosage_form": "TABLET", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "42794-016", "generic_name": "ASENAPINE", "labeler_name": "Sigmapharm Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ASENAPINE", "active_ingredients": [{"name": "ASENAPINE", "strength": "5 mg/1"}], "application_number": "ANDA206107", "marketing_category": "ANDA", "marketing_start_date": "20201214", "listing_expiration_date": "20261231"}