entecavir

Generic: entecavir

Labeler: epic pharma, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name entecavir
Generic Name entecavir
Labeler epic pharma, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

entecavir .5 mg/1

Manufacturer
EPIC PHARMA, LLC

Identifiers & Regulatory

Product NDC 42806-658
Product ID 42806-658_db290579-c9e1-44be-b03c-ad8a7efe5ce1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212126
Listing Expiration 2027-12-31
Marketing Start 2020-06-02

Pharmacologic Class

Classes
hepatitis b virus nucleoside analog reverse transcriptase inhibitor [epc] nucleoside analog [ext] nucleoside reverse transcriptase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42806658
Hyphenated Format 42806-658

Supplemental Identifiers

RxCUI
485434 485436
UPC
0342806658307 0342806659304
UNII
5968Y6H45M

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 entecavir (source: ndc)
Generic Name entecavir (source: ndc)
Application Number ANDA212126 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE, PLASTIC (42806-658-30)
source: ndc

Packages (1)

42806-658-30 30 TABLET in 1 BOTTLE, PLASTIC (42806-658-30)

Ingredients (1)

entecavir (.5 mg/1)

Linked Drug Pages (1)

Entecavir ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "db290579-c9e1-44be-b03c-ad8a7efe5ce1", "openfda": {"upc": ["0342806658307", "0342806659304"], "unii": ["5968Y6H45M"], "rxcui": ["485434", "485436"], "spl_set_id": ["af4f47e2-f556-40f2-a0fd-ff81e9f27429"], "manufacturer_name": ["EPIC PHARMA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (42806-658-30)", "package_ndc": "42806-658-30", "marketing_start_date": "20200602"}], "brand_name": "Entecavir", "product_id": "42806-658_db290579-c9e1-44be-b03c-ad8a7efe5ce1", "dosage_form": "TABLET", "pharm_class": ["Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]", "Nucleoside Analog [EXT]", "Nucleoside Reverse Transcriptase Inhibitors [MoA]"], "product_ndc": "42806-658", "generic_name": "Entecavir", "labeler_name": "EPIC PHARMA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Entecavir", "active_ingredients": [{"name": "ENTECAVIR", "strength": ".5 mg/1"}], "application_number": "ANDA212126", "marketing_category": "ANDA", "marketing_start_date": "20200602", "listing_expiration_date": "20271231"}