emtricitabine and tenofovir disoproxil fumarate

Generic: emtricitabine and tenofovir disoproxil fumarate

Labeler: zydus lifesciences limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name emtricitabine and tenofovir disoproxil fumarate
Generic Name emtricitabine and tenofovir disoproxil fumarate
Labeler zydus lifesciences limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

emtricitabine 167 mg/1, tenofovir disoproxil fumarate 250 mg/1

Manufacturer
Zydus Lifesciences Limited

Identifiers & Regulatory

Product NDC 70771-1622
Product ID 70771-1622_8fb1b15c-e324-4410-9a1b-2b3a2ffee3f6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212689
Listing Expiration 2026-12-31
Marketing Start 2021-07-01

Pharmacologic Class

Established (EPC)
human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor [epc]
Mechanism of Action
nucleoside reverse transcriptase inhibitors [moa]
Chemical Structure
nucleosides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 707711622
Hyphenated Format 70771-1622

Supplemental Identifiers

RxCUI
476556 1744001 1744005 1744009
UNII
OTT9J7900I G70B4ETF4S
NUI
N0000175462 M0015066 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 emtricitabine and tenofovir disoproxil fumarate (source: ndc)
Generic Name emtricitabine and tenofovir disoproxil fumarate (source: ndc)
Application Number ANDA212689 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 167 mg/1
  • 250 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (70771-1622-3)
  • 10 BLISTER PACK in 1 CARTON (70771-1622-4) / 10 TABLET, FILM COATED in 1 BLISTER PACK (70771-1622-2)
  • 90 TABLET, FILM COATED in 1 BOTTLE (70771-1622-9)
source: ndc

Packages (3)

70771-1622-3 30 TABLET, FILM COATED in 1 BOTTLE (70771-1622-3) 70771-1622-4 10 BLISTER PACK in 1 CARTON (70771-1622-4) / 10 TABLET, FILM COATED in 1 BLISTER PACK (70771-1622-2) 70771-1622-9 90 TABLET, FILM COATED in 1 BOTTLE (70771-1622-9)

Ingredients (2)

emtricitabine (167 mg/1) tenofovir disoproxil fumarate (250 mg/1)

Linked Drug Pages (1)

Emtricitabine and tenofovir disoproxil fumarate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "8fb1b15c-e324-4410-9a1b-2b3a2ffee3f6", "openfda": {"nui": ["N0000175462", "M0015066", "N0000009947"], "unii": ["OTT9J7900I", "G70B4ETF4S"], "rxcui": ["476556", "1744001", "1744005", "1744009"], "spl_set_id": ["a0ee89b6-72c3-4b99-8d1c-d7473f1d5ef3"], "pharm_class_cs": ["Nucleosides [CS]"], "pharm_class_epc": ["Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]"], "pharm_class_moa": ["Nucleoside Reverse Transcriptase Inhibitors [MoA]"], "manufacturer_name": ["Zydus Lifesciences Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (70771-1622-3)", "package_ndc": "70771-1622-3", "marketing_start_date": "20210701"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (70771-1622-4)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (70771-1622-2)", "package_ndc": "70771-1622-4", "marketing_start_date": "20210701"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (70771-1622-9)", "package_ndc": "70771-1622-9", "marketing_start_date": "20210701"}], "brand_name": "Emtricitabine and tenofovir disoproxil fumarate", "product_id": "70771-1622_8fb1b15c-e324-4410-9a1b-2b3a2ffee3f6", "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]", "Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]", "Nucleoside Reverse Transcriptase Inhibitors [MoA]", "Nucleoside Reverse Transcriptase Inhibitors [MoA]", "Nucleosides [CS]", "Nucleosides [CS]"], "product_ndc": "70771-1622", "generic_name": "Emtricitabine and tenofovir disoproxil fumarate", "labeler_name": "Zydus Lifesciences Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Emtricitabine and tenofovir disoproxil fumarate", "active_ingredients": [{"name": "EMTRICITABINE", "strength": "167 mg/1"}, {"name": "TENOFOVIR DISOPROXIL FUMARATE", "strength": "250 mg/1"}], "application_number": "ANDA212689", "marketing_category": "ANDA", "marketing_start_date": "20210701", "listing_expiration_date": "20261231"}