entecavir

Generic: entecavir

Labeler: camber pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name entecavir
Generic Name entecavir
Labeler camber pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

entecavir anhydrous 1 mg/1

Manufacturer
Camber Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 31722-834
Product ID 31722-834_2b442999-71b5-88f6-e063-6394a90a9d6e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205740
Listing Expiration 2026-12-31
Marketing Start 2015-08-21

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 31722834
Hyphenated Format 31722-834

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 ANDA205740 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (31722-834-30)
  • 10 TABLET in 1 BLISTER PACK (31722-834-31)
  • 100 TABLET in 1 CARTON (31722-834-32)
  • 90 TABLET in 1 BOTTLE (31722-834-90)
source: ndc

Packages (4)

31722-834-30 30 TABLET in 1 BOTTLE (31722-834-30) 31722-834-31 10 TABLET in 1 BLISTER PACK (31722-834-31) 31722-834-32 100 TABLET in 1 CARTON (31722-834-32) 31722-834-90 90 TABLET in 1 BOTTLE (31722-834-90)

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": "2b442999-71b5-88f6-e063-6394a90a9d6e", "openfda": {"nui": ["N0000175656", "N0000175459", "N0000009947"], "unii": ["NNU2O4609D"], "rxcui": ["485434", "485436"], "spl_set_id": ["01ec50a1-6c6c-46f0-8c74-73542b0a59c3"], "pharm_class_epc": ["Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]"], "pharm_class_moa": ["Nucleoside Reverse Transcriptase Inhibitors [MoA]"], "manufacturer_name": ["Camber Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (31722-834-30)", "package_ndc": "31722-834-30", "marketing_start_date": "20150821"}, {"sample": false, "description": "10 TABLET in 1 BLISTER PACK (31722-834-31)", "package_ndc": "31722-834-31", "marketing_start_date": "20150821"}, {"sample": false, "description": "100 TABLET in 1 CARTON (31722-834-32)", "package_ndc": "31722-834-32", "marketing_start_date": "20150821"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (31722-834-90)", "package_ndc": "31722-834-90", "marketing_start_date": "20150821"}], "brand_name": "Entecavir", "product_id": "31722-834_2b442999-71b5-88f6-e063-6394a90a9d6e", "dosage_form": "TABLET", "pharm_class": ["Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]", "Nucleoside Analog [EXT]", "Nucleoside Reverse Transcriptase Inhibitors [MoA]"], "product_ndc": "31722-834", "generic_name": "Entecavir", "labeler_name": "Camber Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Entecavir", "active_ingredients": [{"name": "ENTECAVIR ANHYDROUS", "strength": "1 mg/1"}], "application_number": "ANDA205740", "marketing_category": "ANDA", "marketing_start_date": "20150821", "listing_expiration_date": "20261231"}