complera

Generic: emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate

Labeler: gilead sciences, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name complera
Generic Name emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate
Labeler gilead sciences, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

emtricitabine 200 mg/1, rilpivirine hydrochloride 25 mg/1, tenofovir disoproxil fumarate 300 mg/1

Manufacturer
Gilead Sciences, Inc.

Identifiers & Regulatory

Product NDC 61958-1101
Product ID 61958-1101_21d7850d-11ea-43cc-84a5-0dae02a19ce6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA202123
Listing Expiration 2026-12-31
Marketing Start 2011-08-10

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 619581101
Hyphenated Format 61958-1101

Supplemental Identifiers

RxCUI
1147334 1147337
UNII
G70B4ETF4S 212WAX8KDD OTT9J7900I
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 complera (source: ndc)
Generic Name emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate (source: ndc)
Application Number NDA202123 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
  • 25 mg/1
  • 300 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (61958-1101-1)
source: ndc

Packages (1)

61958-1101-1 30 TABLET, FILM COATED in 1 BOTTLE (61958-1101-1)

Ingredients (3)

emtricitabine (200 mg/1) rilpivirine hydrochloride (25 mg/1) tenofovir disoproxil fumarate (300 mg/1)

Linked Drug Pages (1)

COMPLERA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "21d7850d-11ea-43cc-84a5-0dae02a19ce6", "openfda": {"nui": ["N0000175462", "M0015066", "N0000009947"], "unii": ["G70B4ETF4S", "212WAX8KDD", "OTT9J7900I"], "rxcui": ["1147334", "1147337"], "spl_set_id": ["d637cfab-f1e8-4eb3-a1b3-f85ca3bec612"], "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": ["Gilead Sciences, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (61958-1101-1)", "package_ndc": "61958-1101-1", "marketing_start_date": "20110810"}], "brand_name": "COMPLERA", "product_id": "61958-1101_21d7850d-11ea-43cc-84a5-0dae02a19ce6", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]", "Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]", "Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]", "Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]", "Non-Nucleoside Analog [EXT]", "Non-Nucleoside Reverse Transcriptase Inhibitors [MoA]", "Nucleoside Reverse Transcriptase Inhibitors [MoA]", "Nucleoside Reverse Transcriptase Inhibitors [MoA]", "Nucleosides [CS]", "Nucleosides [CS]"], "product_ndc": "61958-1101", "generic_name": "emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate", "labeler_name": "Gilead Sciences, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "COMPLERA", "active_ingredients": [{"name": "EMTRICITABINE", "strength": "200 mg/1"}, {"name": "RILPIVIRINE HYDROCHLORIDE", "strength": "25 mg/1"}, {"name": "TENOFOVIR DISOPROXIL FUMARATE", "strength": "300 mg/1"}], "application_number": "NDA202123", "marketing_category": "NDA", "marketing_start_date": "20110810", "listing_expiration_date": "20261231"}