baraclude

Generic: entecavir

Labeler: e.r. squibb & sons, l.l.c.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name baraclude
Generic Name entecavir
Labeler e.r. squibb & sons, l.l.c.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

entecavir 1 mg/1

Manufacturer
E.R. Squibb & Sons, L.L.C.

Identifiers & Regulatory

Product NDC 0003-1612
Product ID 0003-1612_275a2584-65d6-40f8-8aac-49eb54479f6d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021797
Listing Expiration 2026-12-31
Marketing Start 2005-03-29

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 00031612
Hyphenated Format 0003-1612

Supplemental Identifiers

RxCUI
485434 485436 485536 578457 578459 607579
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 baraclude (source: ndc)
Generic Name entecavir (source: ndc)
Application Number NDA021797 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (0003-1612-12) / 30 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (1)

0003-1612-12 1 BOTTLE in 1 CARTON (0003-1612-12) / 30 TABLET, FILM COATED in 1 BOTTLE

Ingredients (1)

entecavir (1 mg/1)

Linked Drug Pages (1)

BARACLUDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "275a2584-65d6-40f8-8aac-49eb54479f6d", "openfda": {"unii": ["5968Y6H45M"], "rxcui": ["485434", "485436", "485536", "578457", "578459", "607579"], "spl_set_id": ["046e61c9-9298-4b2e-b76e-b26b81fecd20"], "manufacturer_name": ["E.R. Squibb & Sons, L.L.C."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (0003-1612-12)  / 30 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "0003-1612-12", "marketing_start_date": "20050329"}], "brand_name": "BARACLUDE", "product_id": "0003-1612_275a2584-65d6-40f8-8aac-49eb54479f6d", "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": "0003-1612", "generic_name": "entecavir", "labeler_name": "E.R. Squibb & Sons, L.L.C.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BARACLUDE", "active_ingredients": [{"name": "ENTECAVIR", "strength": "1 mg/1"}], "application_number": "NDA021797", "marketing_category": "NDA", "marketing_start_date": "20050329", "listing_expiration_date": "20261231"}