entacapone

Generic: entacapone

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

Drug Facts

Product Profile

Brand Name entacapone
Generic Name entacapone
Labeler alembic pharmaceuticals limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

entacapone 200 mg/1

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-478
Product ID 46708-478_49e45c73-b4c8-4f0e-8ad7-5a025ca5d5c8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212601
Listing Expiration 2026-12-31
Marketing Start 2022-01-06

Pharmacologic Class

Established (EPC)
catechol-o-methyltransferase inhibitor [epc]
Mechanism of Action
catechol o-methyltransferase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 46708478
Hyphenated Format 46708-478

Supplemental Identifiers

RxCUI
317094
UNII
4975G9NM6T
NUI
N0000175756 N0000175757

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 entacapone (source: ndc)
Generic Name entacapone (source: ndc)
Application Number ANDA212601 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (46708-478-31)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (46708-478-91)
source: ndc

Packages (2)

46708-478-31 100 TABLET, FILM COATED in 1 BOTTLE (46708-478-31) 46708-478-91 1000 TABLET, FILM COATED in 1 BOTTLE (46708-478-91)

Ingredients (1)

entacapone (200 mg/1)

Linked Drug Pages (1)

ENTACAPONE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "49e45c73-b4c8-4f0e-8ad7-5a025ca5d5c8", "openfda": {"nui": ["N0000175756", "N0000175757"], "unii": ["4975G9NM6T"], "rxcui": ["317094"], "spl_set_id": ["d21ce241-b05a-413e-b19a-249ae42012a8"], "pharm_class_epc": ["Catechol-O-Methyltransferase Inhibitor [EPC]"], "pharm_class_moa": ["Catechol O-Methyltransferase Inhibitors [MoA]"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (46708-478-31)", "package_ndc": "46708-478-31", "marketing_start_date": "20220106"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (46708-478-91)", "package_ndc": "46708-478-91", "marketing_start_date": "20220106"}], "brand_name": "ENTACAPONE", "product_id": "46708-478_49e45c73-b4c8-4f0e-8ad7-5a025ca5d5c8", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Catechol O-Methyltransferase Inhibitors [MoA]", "Catechol-O-Methyltransferase Inhibitor [EPC]"], "product_ndc": "46708-478", "generic_name": "ENTACAPONE", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ENTACAPONE", "active_ingredients": [{"name": "ENTACAPONE", "strength": "200 mg/1"}], "application_number": "ANDA212601", "marketing_category": "ANDA", "marketing_start_date": "20220106", "listing_expiration_date": "20261231"}