NDC 0378-9080

Entacapone

Entacapone

Entacapone is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Entacapone.

• Product ID: 0378-9080_41c1308a-6231-47eb-8725-3b4f3a1e7f84
• NDC: 0378-9080
• Product Type: Human Prescription Drug
• Proprietary Name: Entacapone
• Generic Name: Entacapone
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2013-06-26
• Marketing Category: NDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
• Application Number: NDA020796
• Labeler Name: Mylan Pharmaceuticals Inc.
• Substance Name: ENTACAPONE
• Active Ingredient Strength: 200 mg/1
• Pharm Classes: Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0378-9080-01

100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-9080-01)

• Marketing Start Date: 2013-06-26
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0378-9080-01 [00378908001]

Entacapone TABLET, FILM COATED

• Marketing Category: NDA authorized generic
• Application Number: NDA020796
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2013-06-26

Drug Details

Active Ingredients

Ingredient	Strength
ENTACAPONE	200 mg/1

OpenFDA Data

• SPL SET ID: e41bbc90-bb83-4514-a38f-994e9fa76472
• Manufacturer:
  • Mylan Pharmaceuticals Inc.
• UNII:
  • 4975G9NM6T
• RxNorm Concept Unique ID - RxCUI:
  • 317094
• UPC Code:
  • 0303789080011

Pharmacological Class

• Catechol O-Methyltransferase Inhibitors [MoA]
• Catechol-O-Methyltransferase Inhibitor [EPC]
• Catechol O-Methyltransferase Inhibitors [MoA]
• Catechol-O-Methyltransferase Inhibitor [EPC]

NDC Crossover Matching brand name "Entacapone" or generic name "Entacapone"

NDC	Brand Name	Generic Name
0378-9080	Entacapone	Entacapone
0527-1830	Entacapone	entacapone
0615-8298	Entacapone	Entacapone
0781-5578	Entacapone	Entacapone
0904-6822	Entacapone	Entacapone
27241-049	Entacapone	Entacapone
33342-260	Entacapone	Entacapone
43353-996	Entacapone	Entacapone
46708-478	ENTACAPONE	ENTACAPONE
47335-007	Entacapone	Entacapone
48792-7830	Entacapone	entacapone
50268-295	Entacapone	Entacapone
51079-273	Entacapone	Entacapone
55648-290	Entacapone	Entacapone
55648-711	Entacapone	Entacapone
55648-781	Entacapone	Entacapone
60687-188	Entacapone	Entacapone
62332-478	ENTACAPONE	ENTACAPONE
64679-290	Entacapone	Entacapone
64679-711	Entacapone	Entacapone
64679-781	Entacapone	Entacapone
71610-247	Entacapone	Entacapone
65862-654	Entacapone	Entacapone
0078-0327	Comtan	entacapone
52427-800	Comtan	entacapone