entecavir

Generic: entecavir

Labeler: yaopharma co., ltd.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name entecavir
Generic Name entecavir
Labeler yaopharma co., ltd.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

entecavir 1 mg/1

Manufacturer
Yaopharma Co., Ltd.

Identifiers & Regulatory

Product NDC 50771-014
Product ID 50771-014_4502e388-5064-bd87-e063-6294a90a4b1c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212201
Listing Expiration 2026-12-31
Marketing Start 2023-07-01

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 50771014
Hyphenated Format 50771-014

Supplemental Identifiers

RxCUI
485434 485436
UPC
0350771013014 0350771014011 0350771013021
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 ANDA212201 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (50771-014-01)
source: ndc

Packages (1)

50771-014-01 30 TABLET, FILM COATED in 1 BOTTLE (50771-014-01)

Ingredients (1)

entecavir (1 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": "4502e388-5064-bd87-e063-6294a90a4b1c", "openfda": {"upc": ["0350771013014", "0350771014011", "0350771013021"], "unii": ["5968Y6H45M"], "rxcui": ["485434", "485436"], "spl_set_id": ["73dea2a4-a596-477f-b66d-5a80dd019837"], "manufacturer_name": ["Yaopharma Co., Ltd."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (50771-014-01)", "package_ndc": "50771-014-01", "marketing_start_date": "20230701"}], "brand_name": "ENTECAVIR", "product_id": "50771-014_4502e388-5064-bd87-e063-6294a90a4b1c", "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": "50771-014", "generic_name": "entecavir", "labeler_name": "Yaopharma Co., Ltd.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ENTECAVIR", "active_ingredients": [{"name": "ENTECAVIR", "strength": "1 mg/1"}], "application_number": "ANDA212201", "marketing_category": "ANDA", "marketing_start_date": "20230701", "listing_expiration_date": "20261231"}