emtricitabine and tenofovir disoproxil fumarate (68180-287)

Drug Facts

Product Profile

Brand Name emtricitabine and tenofovir disoproxil fumarate

Generic Name emtricitabine and tenofovir disoproxil fumarate

Labeler lupin pharmaceuticals, inc.

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

emtricitabine 200 mg/1, tenofovir disoproxil fumarate 300 mg/1

Manufacturer

Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68180-287

Product ID 68180-287_1b7981ee-8124-46a2-9aab-f9b85d982650

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA204131

Listing Expiration 2026-12-31

Marketing Start 2021-06-23

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 68180287

Hyphenated Format 68180-287

Supplemental Identifiers

RxCUI

476556

UNII

G70B4ETF4S 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 emtricitabine and tenofovir disoproxil fumarate (source: ndc)

Generic Name emtricitabine and tenofovir disoproxil fumarate (source: ndc)

Application Number ANDA204131 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

200 mg/1
300 mg/1

source: ndc

Packaging

16 HOW SUPPLIED/STORAGE AND HANDLING Emtricitabine and tenofovir disoproxil fumarate tablets are available in bottles containing 30 and 100 tablets with child-resistant closure as follows: 200 mg of FTC and 300 mg of TDF (equivalent to 245 mg of tenofovir disoproxil) tablets are white, capsule shaped, biconvex, film-coated, debossed with "LU" on one side and "Q31" on the other side. Bottles of 30 68180-287-06 Bottles of 100 68180-287-01 Store at 25 C (77 F); excursions permitted to 15º to 30 C (59 to 86 F) [See USP Controlled Room Temperature]. Keep container tightly closed Dispense only in original container
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 68180-287-06 Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, 200 mg/300 mg Bottle of 30 tablets Rx only NDC 68180-287-01 Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, 200 mg/300 mg Bottle of 100 tablets Rx only Goa Label image 3

source: label

Packages (0)

No package records.

Ingredients (2)

emtricitabine (200 mg/1) tenofovir disoproxil fumarate (300 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": "1b7981ee-8124-46a2-9aab-f9b85d982650", "openfda": {"nui": ["N0000175462", "M0015066", "N0000009947"], "unii": ["G70B4ETF4S", "OTT9J7900I"], "rxcui": ["476556"], "spl_set_id": ["e4fb5710-e23b-429e-9b51-c12366e614fc"], "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": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [], "brand_name": "EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE", "product_id": "68180-287_1b7981ee-8124-46a2-9aab-f9b85d982650", "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": "68180-287", "generic_name": "EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE", "active_ingredients": [{"name": "EMTRICITABINE", "strength": "200 mg/1"}, {"name": "TENOFOVIR DISOPROXIL FUMARATE", "strength": "300 mg/1"}], "application_number": "ANDA204131", "marketing_category": "ANDA", "marketing_start_date": "20210623", "listing_expiration_date": "20261231"}