FDA.reportPublic FDA data

entecavir 0.5 MG Oral Tablet

RxCUI
485434
RxNorm name
entecavir 0.5 MG Oral Tablet
Display name
entecavir 0.5 MG Oral Tablet
Full name
entecavir 0.5 MG Oral Tablet
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:38:46

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 17 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ENTECAVIRENTECAVIRYaopharma Co., Ltd.73dea2a4-a596-477f-b66d-5a80dd0198372026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485434
ENTECAVIRENTECAVIRCipla USA Inc.d59e9ea4-09ea-47bd-af2f-39f7a2e2aceb2026-06-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485434
EntecavirENTECAVIRAvKARE5a1cbf7e-0352-aa3b-080c-222a6423ecd82026-05-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485434
ENTECAVIRENTECAVIRNorthStar RxLLCda705339-c349-444f-a058-4f0cef2864bf2026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485434
EntecavirENTECAVIRGolden State Medical Supply, Inc.20d62f1a-2e48-69dd-e063-6294a90ace312026-02-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485434
EntecavirENTECAVIREpic Pharma, LLCd69451df-e204-4a5c-a2bb-9e6d4d5193022026-02-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485434
EntecavirENTECAVIREPIC PHARMA, LLCaf4f47e2-f556-40f2-a0fd-ff81e9f274292026-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485434
EntecavirENTECAVIRCarlsbad Technology, Inc.1a905283-0057-a7dd-e063-6394a90a19092026-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485434
ENTECAVIRENTECAVIR ANHYDROUSCameron Pharmaceuticals92a5bebd-6408-463d-933c-bab8338a677e2025-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485434
EntecavirENTECAVIRCamber Pharmaceuticals, Inc.01ec50a1-6c6c-46f0-8c74-73542b0a59c32025-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485434
EntecavirENTECAVIRZydus Lifesciences Limited0e3b2a0a-9076-4907-bbaf-eb6a65bb94812024-11-28Exact identifier
rxcui: 485434
ENTECAVIRENTECAVIRSolco Healthcare LLCbb1bb6dc-0120-46e2-ad1e-d9afc221fa162024-11-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485434
EntecavirENTECAVIRAmerican Health Packaginga0d2e00d-21f0-4449-93b7-a19fa284d51d2024-08-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485434
EntecavirENTECAVIRAurobindo Pharma Limiteddef332bf-2906-4a6c-b85d-dfb56bb943122023-11-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485434
EntecavirENTECAVIRZydus Pharmaceuticals USA Inc.b4fd0e22-ad23-4f51-9b98-95182f63c2eb2023-10-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485434
EntecavirENTECAVIRAmneal Pharmaceuticals LLC007a6ad8-4d23-4543-ae48-c651cac7dd7b2019-11-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485434
BARACLUDEENTECAVIRE.R. Squibb & Sons, L.L.C.046e61c9-9298-4b2e-b76e-b26b81fecd202019-11-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485434

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 18 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
046e61c9-9298-4b2e-b76e-b26b81fecd20entecavir 0.5 MG Oral Tablet [PSN] · entecavir 0.5 MG Oral Tablet [SCD]242These highlights do not include all the information needed to use BARACLUDE safely and effectively. See full prescribing information for BARACLUDE. BARACLUDE ® (entecavir) tablets, for oral use BARACLUDE ® (entecavir) oral solution Initial U.S. Approval: 200520191106
007a6ad8-4d23-4543-ae48-c651cac7dd7bentecavir 0.5 MG Oral Tablet [PSN] · entecavir 0.5 MG Oral Tablet [SCD]219These highlights do not include all the information needed to use ENTECAVIR TABLETS safely and effectively. See full prescribing information for ENTECAVIR TABLETS. ENTECAVIR tablets, for oral use Initial U.S. Approval: 200520191124
d59e9ea4-09ea-47bd-af2f-39f7a2e2acebentecavir 0.5 MG Oral Tablet [PSN] · entecavir 0.5 MG Oral Tablet [SCD]216These highlights do not include all the information needed to use ENTECAVIR TABLETS safely and effectively. See full prescribing information for ENTECAVIR TABLETS. ENTECAVIR tablets, for oral use Initial U.S. Approval: 200520221223
5a1cbf7e-0352-aa3b-080c-222a6423ecd8entecavir 0.5 MG Oral Tablet [PSN] · entecavir 0.5 MG Oral Tablet [SCD]213Entecavir Tablets, USP Rx Only These highlights do not include all the information needed to use ENTECAVIR TABLETS safely and effectively. See full prescribing information for ENTECAVIR TABLETS. Initial U.S. Approval: 200520260513
73dea2a4-a596-477f-b66d-5a80dd019837entecavir 0.5 MG Oral Tablet [PSN] · entecavir 0.5 MG Oral Tablet [SCD]212HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ENTECAVIR TABLETS safely and effectively. See full prescribing information for ENTECAVIR TABLETS. ENTECAVIR TABLETS, for oral use Initial U.S. Approval: 200520251202
bb1bb6dc-0120-46e2-ad1e-d9afc221fa16entecavir 0.5 MG Oral Tablet [PSN] · entecavir 0.5 MG Oral Tablet [SCD]210These highlights do not include all the information needed to use ENTECAVIR TABLETS safely and effectively. See full prescribing information for ENTECAVIR TABLETS. ENTECAVIR tablets, for oral use Initial U.S. Approval: 200520241120
b4fd0e22-ad23-4f51-9b98-95182f63c2ebentecavir 0.5 MG Oral Tablet [PSN] · entecavir 0.5 MG Oral Tablet [SCD]210These highlights do not include all the information needed to use ENTECAVIR TABLETS safely and effectively. See full prescribing information for ENTECAVIR TABLETS. ENTECAVIR tablets, for oral use Initial U.S. Approval: 200520231005
def332bf-2906-4a6c-b85d-dfb56bb94312entecavir 0.5 MG Oral Tablet [PSN] · entecavir 0.5 MG Oral Tablet [SCD]29These highlights do not include all the information needed to use ENTECAVIR TABLETS safely and effectively. See full prescribing information for ENTECAVIR TABLETS. ENTECAVIR tablets, for oral use Initial U.S. Approval: 200520231123
da705339-c349-444f-a058-4f0cef2864bfentecavir 0.5 MG Oral Tablet [PSN] · entecavir 0.5 MG Oral Tablet [SCD]28These highlights do not include all the information needed to use ENTECAVIR TABLETS safely and effectively. See full prescribing information for ENTECAVIR TABLETS. ENTECAVIR tablets, for oral use Initial U.S. Approval: 200520260407
a0d2e00d-21f0-4449-93b7-a19fa284d51dentecavir 0.5 MG Oral Tablet [PSN] · entecavir 0.5 MG Oral Tablet [SCD]28These highlights do not include all the information needed to use ENTECAVIR TABLETS safely and effectively. See full prescribing information for ENTECAVIR TABLETS. ENTECAVIR tablets, for oral use Initial U.S. Approval: 200520240815
af4f47e2-f556-40f2-a0fd-ff81e9f27429entecavir 0.5 MG Oral Tablet [PSN] · entecavir 0.5 MG Oral Tablet [SCD]26These highlights do not include all the information needed to use ENTECAVIR TABLETS safely and effectively. See full prescribing information for ENTECAVIR TABLETS. ENTECAVIR tablets, for oral use Initial U.S. Approval: 200520260115
0e3b2a0a-9076-4907-bbaf-eb6a65bb9481entecavir 0.5 MG Oral Tablet [PSN] · entecavir 0.5 MG Oral Tablet [SCD]26ENTECAVIR TABLETS20241128
01ec50a1-6c6c-46f0-8c74-73542b0a59c3entecavir 0.5 MG Oral Tablet [PSN] · entecavir 0.5 MG Oral Tablet [SCD]24These highlights do not include all the information needed to use ENTECAVIR TABLETS safely and effectively. See full prescribing information for ENTECAVIR TABLETS. ENTECAVIR tablets, for oral use Initial U.S. Approval: 200520250109
1a905283-0057-a7dd-e063-6394a90a1909entecavir 0.5 MG Oral Tablet [PSN] · entecavir 0.5 MG Oral Tablet [SCD]23These highlights do not include all the information needed to use ENTECAVIR TABLETS safely andeffectively. See full prescribing information for ENTECAVIR TABLETS. Initial U.S. Approval: 200520260114
20d62f1a-2e48-69dd-e063-6294a90ace31entecavir 0.5 MG Oral Tablet [PSN] · entecavir 0.5 MG Oral Tablet [SCD]22ENTECAVIR TABLETS. These highlights do not include all the information needed to use ENTECAVIR TABLETS safely andeffectively. See full prescribing information for ENTECAVIR TABLETS. Initial U.S. Approval: 200520260218
d69451df-e204-4a5c-a2bb-9e6d4d519302entecavir 0.5 MG Oral Tablet [PSN] · entecavir 0.5 MG Oral Tablet [SCD]21These highlights do not include all the information needed to use ENTECAVIR TABLETS safely and effectively. See full prescribing information for ENTECAVIR TABLETS. ENTECAVIR tablets, for oral use Initial U.S. Approval: 200520260212
92a5bebd-6408-463d-933c-bab8338a677eentecavir 0.5 MG Oral Tablet [PSN] · entecavir 0.5 MG Oral Tablet [SCD]21These highlights do not include all the information needed to use ENTECAVIR TABLETS safely and effectively. See full prescribing information for ENTECAVIR TABLETS. ENTECAVIR tablets, for oral use Initial U.S. Approval: 200520250605
aa3d6d9a-ec31-4d66-8151-ec3bfad799e9entecavir 0.5 MG Oral Tablet [PSN] · entecavir 0.5 MG Oral Tablet [SCD]21These highlights do not include all the information needed to use ENTECAVIR TABLETS safely and effectively. See full prescribing information for ENTECAVIR TABLETS. ENTECAVIR tablets, for oral use Initial U.S. Approval: 200520160301