emtriva

Generic: emtricitabine

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

Drug Facts

Product Profile

Brand Name emtriva
Generic Name emtricitabine
Labeler gilead sciences, inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

emtricitabine 10 mg/mL

Manufacturer
Gilead Sciences, Inc.

Identifiers & Regulatory

Product NDC 61958-0602
Product ID 61958-0602_13ed3577-67a4-4828-b886-f35206f149a6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021896
Listing Expiration 2026-12-31
Marketing Start 2005-09-28

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 619580602
Hyphenated Format 61958-0602

Supplemental Identifiers

RxCUI
403875 404587 597291 616148
UNII
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 emtriva (source: ndc)
Generic Name emtricitabine (source: ndc)
Application Number NDA021896 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DISPENSING in 1 CARTON (61958-0602-1) / 170 mL in 1 BOTTLE, DISPENSING
source: ndc

Packages (1)

61958-0602-1 1 BOTTLE, DISPENSING in 1 CARTON (61958-0602-1) / 170 mL in 1 BOTTLE, DISPENSING

Ingredients (1)

emtricitabine (10 mg/mL)

Linked Drug Pages (1)

Emtriva ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "13ed3577-67a4-4828-b886-f35206f149a6", "openfda": {"nui": ["N0000175462", "M0015066", "N0000009947"], "unii": ["G70B4ETF4S"], "rxcui": ["403875", "404587", "597291", "616148"], "spl_set_id": ["d6599395-3944-44f9-97f2-e0424c6b6a1f"], "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": "1 BOTTLE, DISPENSING in 1 CARTON (61958-0602-1)  / 170 mL in 1 BOTTLE, DISPENSING", "package_ndc": "61958-0602-1", "marketing_start_date": "20050928"}], "brand_name": "Emtriva", "product_id": "61958-0602_13ed3577-67a4-4828-b886-f35206f149a6", "dosage_form": "SOLUTION", "pharm_class": ["Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]", "Nucleoside Reverse Transcriptase Inhibitors [MoA]", "Nucleosides [CS]"], "product_ndc": "61958-0602", "generic_name": "EMTRICITABINE", "labeler_name": "Gilead Sciences, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Emtriva", "active_ingredients": [{"name": "EMTRICITABINE", "strength": "10 mg/mL"}], "application_number": "NDA021896", "marketing_category": "NDA", "marketing_start_date": "20050928", "listing_expiration_date": "20261231"}