What is NDC 0378-5440?

0378-5440 is the product NDC for Emtricitabine, Rilpivirine, Tenofovir Disoproxil Fumarate, Emtricitabine 200 mg/1 + 2 more ingredients tablet, film coated, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Emtricitabine, Rilpivirine, Tenofovir Disoproxil Fumarate.

What is the active ingredient?

Emtricitabine, Rilpivirine hydrochloride, Tenofovir disoproxil fumarate.

Mylan Pharmaceuticals Inc., NDC labeler code 0378. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Emtricitabine, Rilpivirine, Tenofovir Disoproxil Fumarate?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

NDC 0378-5440

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-5440Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-5440Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
0378-5440-93	0037854409300378544093	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5440-93)Marketed from May 27, 2025

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Emtricitabine, Rilpivirine, Tenofovir Disoproxil Fumarate
Generic name (nonproprietary): emtricitabine, rilpivirine, tenofovir disoproxil fumarate
Active ingredients: Emtricitabine — 200 mg/1Rilpivirine hydrochloride — 25 mg/1Tenofovir disoproxil fumarate — 300 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Mylan Pharmaceuticals Inc.NDC labeler code 0378
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208452
Marketing start: May 27, 2025
Listing expires: Dec 31, 2027
Other FDA classes: Non-Nucleoside Analog (EXT)Non-Nucleoside Reverse Transcriptase Inhibitors (Mechanism)Nucleoside Reverse Transcriptase Inhibitors (Mechanism)Nucleoside Reverse Transcriptase Inhibitors (Mechanism)Nucleosides (Chemical structure)Nucleosides (Chemical structure)
Identifiers: Product ID 0378-5440_d9a4185e-43fa-4aeb-9b0f-8db01b166038SPL ID d9a4185e-43fa-4aeb-9b0f-8db01b166038SPL set ID d9a4185e-43fa-4aeb-9b0f-8db01b166038RxCUI 1147334UNII G70B4ETF4S, 212WAX8KDD, OTT9J7900I
Pharmacologic class: Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor; Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor; Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N400378544093 followed by a unit qualifier and the quantity

Package 00378-5440-93. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Dec 14, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

Emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets are indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 35 kg: • as initial therapy in those with no antiretroviral treatment history with HIV-1 RNA less than or equal to 100,000 copies/mL at the start of therapy or • to replace a stable antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen for at least 6 months with no treatment failure and no known substitutions associated with resistance to the individual components of emtricitabine, rilpivirine and tenofovir disoproxil fuma…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0378-5440

What is NDC 0378-5440?: 0378-5440 is the product NDC for Emtricitabine, Rilpivirine, Tenofovir Disoproxil Fumarate, Emtricitabine 200 mg/1 + 2 more ingredients tablet, film coated, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Emtricitabine, Rilpivirine, Tenofovir Disoproxil Fumarate.
What is the active ingredient?: Emtricitabine, Rilpivirine hydrochloride, Tenofovir disoproxil fumarate.
Who is the labeler?: Mylan Pharmaceuticals Inc., NDC labeler code 0378. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Emtricitabine, Rilpivirine, Tenofovir Disoproxil Fumarate?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Emtricitabine, Rilpivirine, Tenofovir Disoproxil Fumarate NDC 0378-5440