15 companies list entecavir as a human prescription drug in the openFDA NDC Directory, led by Epic Laboratories, LLC, E.R. Squibb & Sons, L.L.C., Zydus Lifesciences Limited, CIPLA PHARMACEUTICALS LIMITED, Aurobindo Pharma Limited. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.

Is there a generic BARACLUDE?

14 companies list entecavir under an abbreviated new drug application (ANDA), the application type used for generics, and 1 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.

Who supplies entecavir active ingredient?

9 companies list entecavir as a bulk ingredient, including Amneal Pharmaceuticals Co. (I) Pvt. Ltd., Aurobindo Pharma Limited, CIPLA PHARMACEUTICALS LIMITED, Hetero Drugs Limited.

Drug

Who makes entecavir?

15 companies list entecavir as a human prescription drug, including under the names BARACLUDE. Forms: solution; tablet; tablet, film coated. Routes: oral.

Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology

Companies listing entecavir

Company	Forms	Application	NDCs	Registered sites
Epic Laboratories, LLCUnited States	tablet; tablet, film coated	ANDAANDA212126, ANDA216857	4	3
E.R. Squibb & Sons, L.L.C.	solution; tablet, film coated	NDANDA021797, NDA021798	3	0
Zydus Lifesciences LimitedIndia	tablet, film coated	ANDAANDA206745	2	12
CIPLA PHARMACEUTICALS LIMITEDIndia	tablet, film coated	ANDAANDA206872	2	7
Aurobindo Pharma LimitedIndia	tablet	ANDAANDA206217	2	6
Amneal Ireland LimitedIreland	tablet, film coated	ANDAANDA206652	2	1
Camber Pharmaceuticals, Inc.United States	tablet	ANDAANDA205740	2	1
Yaopharma Co., Ltd.China	tablet, film coated	ANDAANDA212201	2	1
Zydus Pharmaceuticals USA Inc.India	tablet, film coated	ANDAANDA206745	2	1
NorthStar RxLLC	tablet, film coated	ANDAANDA206872	2	0
Solco healthcare U.S., LLC	tablet, film coated	ANDAANDA208782	2	0
Pharma Packaging Solutions, LLC dba Tjoapack, LLCUnited States	tablet	ANDAANDA206217	1	5
Carlsbad Technology, Inc.United States	tablet	ANDAANDA208195	1	1
Golden State Medical Supply Inc.United States	tablet	ANDAANDA208195	1	1
AvKARE	tablet, film coated	ANDAANDA206652	1	0

Bulk ingredient listings

Amneal Pharmaceuticals Co. (I) Pvt. Ltd. · 2 NDC
Aurobindo Pharma LimitedIndia · 1 NDC
CIPLA PHARMACEUTICALS LIMITEDIndia · 1 NDC
Hetero Drugs LimitedIndia · 1 NDC
Siegfried Evionnaz SA · 1 NDC
Wisdom Pharmaceutical Co., Ltd.China · 1 NDC
Zhejiang Ausun Pharmaceutical Co., Ltd.China · 1 NDC
Zhejiang Huahai Pharmaceutical Technology Co LtdChina · 1 NDC
Zydus Lifesciences LimitedIndia · 1 NDC

Enquiry

Common questions

Who makes entecavir?: 15 companies list entecavir as a human prescription drug in the openFDA NDC Directory, led by Epic Laboratories, LLC, E.R. Squibb & Sons, L.L.C., Zydus Lifesciences Limited, CIPLA PHARMACEUTICALS LIMITED, Aurobindo Pharma Limited. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
Is there a generic BARACLUDE?: 14 companies list entecavir under an abbreviated new drug application (ANDA), the application type used for generics, and 1 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
Who supplies entecavir active ingredient?: 9 companies list entecavir as a bulk ingredient, including Amneal Pharmaceuticals Co. (I) Pvt. Ltd., Aurobindo Pharma Limited, CIPLA PHARMACEUTICALS LIMITED, Hetero Drugs Limited.