entacapone

Generic: entacapone

Labeler: ajanta pharma usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name entacapone
Generic Name entacapone
Labeler ajanta pharma usa inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

entacapone 200 mg/1

Manufacturer
Ajanta Pharma USA Inc.

Identifiers & Regulatory

Product NDC 27241-049
Product ID 27241-049_bde2e229-3bc5-4d26-9bd8-0f679955ff33
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205792
Listing Expiration 2026-12-31
Marketing Start 2017-08-31

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 27241049
Hyphenated Format 27241-049

Supplemental Identifiers

RxCUI
317094
UPC
0327241049101
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 ANDA205792 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (27241-049-10)
source: ndc

Packages (1)

27241-049-10 100 TABLET in 1 BOTTLE (27241-049-10)

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": "bde2e229-3bc5-4d26-9bd8-0f679955ff33", "openfda": {"nui": ["N0000175756", "N0000175757"], "upc": ["0327241049101"], "unii": ["4975G9NM6T"], "rxcui": ["317094"], "spl_set_id": ["e9e94e9f-cd7a-45f5-9aeb-9c28ed804d8c"], "pharm_class_epc": ["Catechol-O-Methyltransferase Inhibitor [EPC]"], "pharm_class_moa": ["Catechol O-Methyltransferase Inhibitors [MoA]"], "manufacturer_name": ["Ajanta Pharma USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (27241-049-10)", "package_ndc": "27241-049-10", "marketing_start_date": "20170831"}], "brand_name": "Entacapone", "product_id": "27241-049_bde2e229-3bc5-4d26-9bd8-0f679955ff33", "dosage_form": "TABLET", "pharm_class": ["Catechol O-Methyltransferase Inhibitors [MoA]", "Catechol-O-Methyltransferase Inhibitor [EPC]"], "product_ndc": "27241-049", "generic_name": "Entacapone", "labeler_name": "Ajanta Pharma USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Entacapone", "active_ingredients": [{"name": "ENTACAPONE", "strength": "200 mg/1"}], "application_number": "ANDA205792", "marketing_category": "ANDA", "marketing_start_date": "20170831", "listing_expiration_date": "20261231"}