entecavir

Generic: entecavir

Labeler: northstar rxllc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name entecavir
Generic Name entecavir
Labeler northstar rxllc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

entecavir .5 mg/1

Manufacturer
NorthStar RxLLC

Identifiers & Regulatory

Product NDC 16714-717
Product ID 16714-717_566171a2-a0b1-4064-88bf-77c9a80bd0f1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206872
Listing Expiration 2026-12-31
Marketing Start 2017-06-15

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 16714717
Hyphenated Format 16714-717

Supplemental Identifiers

RxCUI
485434 485436
UPC
0316714718019 0316714717012
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 ANDA206872 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16714-717-01)
source: ndc

Packages (1)

16714-717-01 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16714-717-01)

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": "566171a2-a0b1-4064-88bf-77c9a80bd0f1", "openfda": {"upc": ["0316714718019", "0316714717012"], "unii": ["5968Y6H45M"], "rxcui": ["485434", "485436"], "spl_set_id": ["da705339-c349-444f-a058-4f0cef2864bf"], "manufacturer_name": ["NorthStar RxLLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16714-717-01)", "package_ndc": "16714-717-01", "marketing_start_date": "20170615"}], "brand_name": "ENTECAVIR", "product_id": "16714-717_566171a2-a0b1-4064-88bf-77c9a80bd0f1", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]", "Nucleoside Analog [EXT]", "Nucleoside Reverse Transcriptase Inhibitors [MoA]"], "product_ndc": "16714-717", "generic_name": "ENTECAVIR", "labeler_name": "NorthStar RxLLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ENTECAVIR", "active_ingredients": [{"name": "ENTECAVIR", "strength": ".5 mg/1"}], "application_number": "ANDA206872", "marketing_category": "ANDA", "marketing_start_date": "20170615", "listing_expiration_date": "20261231"}