entecavir

Generic: entecavir

Labeler: carlsbad technology, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name entecavir
Generic Name entecavir
Labeler carlsbad technology, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

entecavir .5 mg/1

Manufacturer
Carlsbad Technology, Inc.

Identifiers & Regulatory

Product NDC 61442-311
Product ID 61442-311_48618328-e6d6-2aa2-e063-6294a90a1d00
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208195
Listing Expiration 2027-12-31
Marketing Start 2021-11-10

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 61442311
Hyphenated Format 61442-311

Supplemental Identifiers

RxCUI
485434
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 ANDA208195 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE, PLASTIC (61442-311-30)
source: ndc

Packages (1)

61442-311-30 30 TABLET in 1 BOTTLE, PLASTIC (61442-311-30)

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": "48618328-e6d6-2aa2-e063-6294a90a1d00", "openfda": {"unii": ["5968Y6H45M"], "rxcui": ["485434"], "spl_set_id": ["1a905283-0057-a7dd-e063-6394a90a1909"], "manufacturer_name": ["Carlsbad Technology, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (61442-311-30)", "package_ndc": "61442-311-30", "marketing_start_date": "20211110"}], "brand_name": "Entecavir", "product_id": "61442-311_48618328-e6d6-2aa2-e063-6294a90a1d00", "dosage_form": "TABLET", "pharm_class": ["Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]", "Nucleoside Analog [EXT]", "Nucleoside Reverse Transcriptase Inhibitors [MoA]"], "product_ndc": "61442-311", "generic_name": "Entecavir", "labeler_name": "Carlsbad Technology, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Entecavir", "active_ingredients": [{"name": "ENTECAVIR", "strength": ".5 mg/1"}], "application_number": "ANDA208195", "marketing_category": "ANDA", "marketing_start_date": "20211110", "listing_expiration_date": "20271231"}