tenofovir disoproxil fumarate

Generic: tenofovir disoproxil fumarate

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

Drug Facts

Product Profile

Brand Name tenofovir disoproxil fumarate
Generic Name tenofovir disoproxil fumarate
Labeler camber pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

tenofovir disoproxil fumarate 300 mg/1

Manufacturer
Camber Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 31722-535
Product ID 31722-535_f3388e9a-2c01-de8d-e053-2a95a90aa213
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090636
Listing Expiration 2026-12-31
Marketing Start 2018-01-26

Pharmacologic Class

Classes
hepatitis b virus nucleoside analog reverse transcriptase inhibitor [epc] human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor [epc] nucleoside reverse transcriptase inhibitors [moa] nucleosides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 31722535
Hyphenated Format 31722-535

Supplemental Identifiers

RxCUI
349251
UPC
0331722535304
UNII
OTT9J7900I

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 tenofovir disoproxil fumarate (source: ndc)
Generic Name tenofovir disoproxil fumarate (source: ndc)
Application Number ANDA090636 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (31722-535-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (31722-535-05)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (31722-535-10)
  • 30 TABLET, FILM COATED in 1 BOTTLE (31722-535-30)
  • 60 TABLET, FILM COATED in 1 BOTTLE (31722-535-60)
source: ndc

Packages (5)

31722-535-01 100 TABLET, FILM COATED in 1 BOTTLE (31722-535-01) 31722-535-05 500 TABLET, FILM COATED in 1 BOTTLE (31722-535-05) 31722-535-10 1000 TABLET, FILM COATED in 1 BOTTLE (31722-535-10) 31722-535-30 30 TABLET, FILM COATED in 1 BOTTLE (31722-535-30) 31722-535-60 60 TABLET, FILM COATED in 1 BOTTLE (31722-535-60)

Ingredients (1)

tenofovir disoproxil fumarate (300 mg/1)

Linked Drug Pages (1)

Tenofovir Disoproxil Fumarate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "f3388e9a-2c01-de8d-e053-2a95a90aa213", "openfda": {"upc": ["0331722535304"], "unii": ["OTT9J7900I"], "rxcui": ["349251"], "spl_set_id": ["1ac4c628-f01f-42d4-b8e6-d12273aefc6d"], "manufacturer_name": ["Camber Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (31722-535-01)", "package_ndc": "31722-535-01", "marketing_start_date": "20180126"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (31722-535-05)", "package_ndc": "31722-535-05", "marketing_start_date": "20180126"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (31722-535-10)", "package_ndc": "31722-535-10", "marketing_start_date": "20180126"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (31722-535-30)", "package_ndc": "31722-535-30", "marketing_start_date": "20180126"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (31722-535-60)", "package_ndc": "31722-535-60", "marketing_start_date": "20180126"}], "brand_name": "Tenofovir Disoproxil Fumarate", "product_id": "31722-535_f3388e9a-2c01-de8d-e053-2a95a90aa213", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]", "Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]", "Nucleoside Reverse Transcriptase Inhibitors [MoA]", "Nucleosides [CS]"], "product_ndc": "31722-535", "generic_name": "Tenofovir Disoproxil Fumarate", "labeler_name": "Camber Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tenofovir Disoproxil Fumarate", "active_ingredients": [{"name": "TENOFOVIR DISOPROXIL FUMARATE", "strength": "300 mg/1"}], "application_number": "ANDA090636", "marketing_category": "ANDA", "marketing_start_date": "20180126", "listing_expiration_date": "20261231"}