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Emtricitabine, Rilpivirine, Tenofovir Disoproxil Fumarate

NDC 0378-5440, Emtricitabine, Rilpivirine, Tenofovir Disoproxil Fumarate, tablet, film coated, from Mylan Pharmaceuticals Inc..

Product NDC
0378-5440
Status
Listed
Labeler
Mylan Pharmaceuticals Inc.
Dosage form
TABLET, FILM COATED
Route
ORAL
Product type
HUMAN PRESCRIPTION DRUG
Marketing category
ANDA
Application
ANDA208452
DEA schedule
None
Request
curl https://api.healthcare.dev/v1/drugs/ndc/0378-5440 \
  -H "Authorization: Bearer $HDEV_API_KEY"

Product

Active ingredients and packages

Active ingredients

  • EMTRICITABINE200 mg/1
  • RILPIVIRINE HYDROCHLORIDE25 mg/1
  • TENOFOVIR DISOPROXIL FUMARATE300 mg/1

Pharmacologic classes

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]

Package NDCNDC-11Package
0378-5440-930037854409330 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5440-93)

Linked data

RxNorm, label and prices

RxNorm concepts

Related lookups

  • FDA label sections

    GET /v1/drugs/labels/d9a4185e-43fa-4aeb-9b0f-8db01b166038
  • NADAC price for package 00378544093

    GET /v1/drugs/nadac/00378544093

Use it

Look up 0378-5440 from code or an agent

curl
curl https://api.healthcare.dev/v1/drugs/ndc/0378-5440 \
  -H "Authorization: Bearer $HDEV_API_KEY"
MCP prompt
Using the healthcare.dev MCP server, look up NDC 0378-5440. Tell me the product, its labeler, dosage form and route, its packages, and the RxNorm concepts it maps to.

Source: FDA, release 2026-10-23. Public domain. Reference data, not medical advice.