emtricitabine

Generic: emtricitabine

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name emtricitabine
Generic Name emtricitabine
Labeler aurobindo pharma limited
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

emtricitabine 200 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-301
Product ID 65862-301_b4553ee9-214c-43d5-b704-16f4eee5f2b6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA079188
Listing Expiration 2026-12-31
Marketing Start 2023-03-15

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 65862301
Hyphenated Format 65862-301

Supplemental Identifiers

RxCUI
403875
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 emtricitabine (source: ndc)
Generic Name emtricitabine (source: ndc)
Application Number ANDA079188 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 500 CAPSULE in 1 BOTTLE (65862-301-05)
  • 30 CAPSULE in 1 BOTTLE (65862-301-30)
source: ndc

Packages (2)

65862-301-05 500 CAPSULE in 1 BOTTLE (65862-301-05) 65862-301-30 30 CAPSULE in 1 BOTTLE (65862-301-30)

Ingredients (1)

emtricitabine (200 mg/1)

Linked Drug Pages (1)

Emtricitabine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b4553ee9-214c-43d5-b704-16f4eee5f2b6", "openfda": {"nui": ["N0000175462", "M0015066", "N0000009947"], "unii": ["G70B4ETF4S"], "rxcui": ["403875"], "spl_set_id": ["cdfb7868-3eba-46e1-a286-ca40760fd98d"], "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": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 CAPSULE in 1 BOTTLE (65862-301-05)", "package_ndc": "65862-301-05", "marketing_start_date": "20230315"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (65862-301-30)", "package_ndc": "65862-301-30", "marketing_start_date": "20230315"}], "brand_name": "Emtricitabine", "product_id": "65862-301_b4553ee9-214c-43d5-b704-16f4eee5f2b6", "dosage_form": "CAPSULE", "pharm_class": ["Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]", "Nucleoside Reverse Transcriptase Inhibitors [MoA]", "Nucleosides [CS]"], "product_ndc": "65862-301", "generic_name": "Emtricitabine", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Emtricitabine", "active_ingredients": [{"name": "EMTRICITABINE", "strength": "200 mg/1"}], "application_number": "ANDA079188", "marketing_category": "ANDA", "marketing_start_date": "20230315", "listing_expiration_date": "20261231"}