asenapine

Generic: asenapine

Labeler: alembic pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name asenapine
Generic Name asenapine
Labeler alembic pharmaceuticals limited
Dosage Form TABLET
Routes
SUBLINGUAL
Active Ingredients

asenapine 5 mg/1

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-198
Product ID 46708-198_b8b5c58b-40db-4b6f-b53d-f11a842bcf28
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206098
Listing Expiration 2026-12-31
Marketing Start 2020-12-10

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 46708198
Hyphenated Format 46708-198

Supplemental Identifiers

RxCUI
859975 859981 1606337
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 ANDA206098 (source: ndc)
Routes
SUBLINGUAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (46708-198-31) / 10 TABLET in 1 BLISTER PACK
  • 60 BLISTER PACK in 1 CARTON (46708-198-60) / 10 TABLET in 1 BLISTER PACK (46708-198-10)
source: ndc

Packages (2)

46708-198-31 100 BLISTER PACK in 1 CARTON (46708-198-31) / 10 TABLET in 1 BLISTER PACK 46708-198-60 60 BLISTER PACK in 1 CARTON (46708-198-60) / 10 TABLET in 1 BLISTER PACK (46708-198-10)

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": "b8b5c58b-40db-4b6f-b53d-f11a842bcf28", "openfda": {"nui": ["N0000175430"], "unii": ["JKZ19V908O"], "rxcui": ["859975", "859981", "1606337"], "spl_set_id": ["cf587c48-9cd2-4dc5-b0e9-21783c5633a6"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (46708-198-31)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "46708-198-31", "marketing_start_date": "20201210"}, {"sample": false, "description": "60 BLISTER PACK in 1 CARTON (46708-198-60)  / 10 TABLET in 1 BLISTER PACK (46708-198-10)", "package_ndc": "46708-198-60", "marketing_start_date": "20201210"}], "brand_name": "Asenapine", "product_id": "46708-198_b8b5c58b-40db-4b6f-b53d-f11a842bcf28", "dosage_form": "TABLET", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "46708-198", "generic_name": "Asenapine", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Asenapine", "active_ingredients": [{"name": "ASENAPINE", "strength": "5 mg/1"}], "application_number": "ANDA206098", "marketing_category": "ANDA", "marketing_start_date": "20201210", "listing_expiration_date": "20261231"}