entecavir

Generic: entecavir

Labeler: cipla usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name entecavir
Generic Name entecavir
Labeler cipla usa inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

entecavir 1 mg/1

Manufacturer
Cipla USA Inc.

Identifiers & Regulatory

Product NDC 69097-425
Product ID 69097-425_f11e1153-612f-4924-86b1-6739d755e3c1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206872
Listing Expiration 2026-12-31
Marketing Start 2016-12-06

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 69097425
Hyphenated Format 69097-425

Supplemental Identifiers

RxCUI
485434 485436
UPC
0369097425029 0369097426026 0369097426057
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
  • 1 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69097-425-02)
source: ndc

Packages (1)

69097-425-02 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69097-425-02)

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": "f11e1153-612f-4924-86b1-6739d755e3c1", "openfda": {"upc": ["0369097425029", "0369097426026", "0369097426057"], "unii": ["5968Y6H45M"], "rxcui": ["485434", "485436"], "spl_set_id": ["d59e9ea4-09ea-47bd-af2f-39f7a2e2aceb"], "manufacturer_name": ["Cipla USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69097-425-02)", "package_ndc": "69097-425-02", "marketing_start_date": "20161206"}], "brand_name": "ENTECAVIR", "product_id": "69097-425_f11e1153-612f-4924-86b1-6739d755e3c1", "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": "69097-425", "generic_name": "ENTECAVIR", "labeler_name": "Cipla USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ENTECAVIR", "active_ingredients": [{"name": "ENTECAVIR", "strength": "1 mg/1"}], "application_number": "ANDA206872", "marketing_category": "ANDA", "marketing_start_date": "20161206", "listing_expiration_date": "20261231"}