NDC 46708-478

ENTACAPONE

Entacapone

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

Product ID46708-478_d21ce241-b05a-413e-b19a-249ae42012a8
NDC46708-478
Product TypeHuman Prescription Drug
Proprietary NameENTACAPONE
Generic NameEntacapone
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2022-01-06
Marketing CategoryANDA /
Application NumberANDA212601
Labeler NameAlembic Pharmaceuticals Limited
Substance NameENTACAPONE
Active Ingredient Strength200 mg/1
Pharm ClassesCatechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 46708-478-31

100 TABLET, FILM COATED in 1 BOTTLE (46708-478-31)
Marketing Start Date2022-01-06
NDC Exclude FlagN
Sample Package?N

Drug Details

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

NDCBrand NameGeneric Name
0378-9080EntacaponeEntacapone
0527-1830Entacaponeentacapone
0615-8298EntacaponeEntacapone
0781-5578EntacaponeEntacapone
0904-6822EntacaponeEntacapone
27241-049EntacaponeEntacapone
33342-260EntacaponeEntacapone
43353-996EntacaponeEntacapone
46708-478ENTACAPONEENTACAPONE
47335-007EntacaponeEntacapone
48792-7830Entacaponeentacapone
50268-295EntacaponeEntacapone
51079-273EntacaponeEntacapone
55648-290EntacaponeEntacapone
55648-711EntacaponeEntacapone
55648-781EntacaponeEntacapone
60687-188EntacaponeEntacapone
62332-478ENTACAPONEENTACAPONE
64679-290EntacaponeEntacapone
64679-711EntacaponeEntacapone
64679-781EntacaponeEntacapone
71610-247EntacaponeEntacapone
65862-654EntacaponeEntacapone
0078-0327Comtanentacapone
52427-800Comtanentacapone

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