entecavir

Generic: entecavir

Labeler: solco healthcare llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name entecavir
Generic Name entecavir
Labeler solco healthcare llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

entecavir anhydrous 1 mg/1

Manufacturer
Solco Healthcare LLC

Identifiers & Regulatory

Product NDC 43547-437
Product ID 43547-437_a5a51ce6-2c18-40de-b266-c3891132bbd1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208782
Listing Expiration 2026-12-31
Marketing Start 2018-04-01

Pharmacologic Class

Established (EPC)
hepatitis b virus nucleoside analog reverse transcriptase inhibitor [epc]
Mechanism of Action
nucleoside reverse transcriptase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43547437
Hyphenated Format 43547-437

Supplemental Identifiers

RxCUI
485434 485436
UNII
NNU2O4609D
NUI
N0000175656 N0000175459 N0000009947

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 ANDA208782 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (43547-437-03)
  • 90 TABLET, FILM COATED in 1 BOTTLE (43547-437-09)
  • 500 TABLET, FILM COATED in 1 BOTTLE (43547-437-50)
source: ndc

Packages (3)

43547-437-03 30 TABLET, FILM COATED in 1 BOTTLE (43547-437-03) 43547-437-09 90 TABLET, FILM COATED in 1 BOTTLE (43547-437-09) 43547-437-50 500 TABLET, FILM COATED in 1 BOTTLE (43547-437-50)

Ingredients (1)

entecavir anhydrous (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": "a5a51ce6-2c18-40de-b266-c3891132bbd1", "openfda": {"nui": ["N0000175656", "N0000175459", "N0000009947"], "unii": ["NNU2O4609D"], "rxcui": ["485434", "485436"], "spl_set_id": ["bb1bb6dc-0120-46e2-ad1e-d9afc221fa16"], "pharm_class_epc": ["Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]"], "pharm_class_moa": ["Nucleoside Reverse Transcriptase Inhibitors [MoA]"], "manufacturer_name": ["Solco Healthcare LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (43547-437-03)", "package_ndc": "43547-437-03", "marketing_start_date": "20180401"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (43547-437-09)", "package_ndc": "43547-437-09", "marketing_start_date": "20180401"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (43547-437-50)", "package_ndc": "43547-437-50", "marketing_start_date": "20180401"}], "brand_name": "ENTECAVIR", "product_id": "43547-437_a5a51ce6-2c18-40de-b266-c3891132bbd1", "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": "43547-437", "generic_name": "ENTECAVIR", "labeler_name": "Solco Healthcare LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ENTECAVIR", "active_ingredients": [{"name": "ENTECAVIR ANHYDROUS", "strength": "1 mg/1"}], "application_number": "ANDA208782", "marketing_category": "ANDA", "marketing_start_date": "20180401", "listing_expiration_date": "20261231"}