What is NDC 49502-475?

49502-475 is the product NDC for Symfi, Efavirenz 600 mg/1 + 2 more ingredients tablet, film coated, listed with the FDA by Viatris Specialty LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

What is the active ingredient?

Efavirenz, Lamivudine, Tenofovir disoproxil fumarate.

Viatris Specialty LLC, NDC labeler code 49502. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Symfi?

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.

Symfi NDC 49502-475 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)49502-475Labeler and product segments. Claims need a package NDC.

Product NDC at billing width49502-0475Add 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
49502-475-93	4950204759349502047593	1 BOTTLE, PLASTIC in 1 CARTON (49502-475-93) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTICMarketed from Apr 25, 2018

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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): Symfi
Generic name (nonproprietary): efavirenz, lamivudine and tenofovir disoproxil fumarate
Active ingredients: Efavirenz — 600 mg/1Lamivudine — 300 mg/1Tenofovir disoproxil fumarate — 300 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Viatris Specialty LLCNDC labeler code 49502
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 022142
Marketing start: Apr 25, 2018
Listing expires: Dec 31, 2027
Other FDA classes: Cytochrome P450 2B6 Inducers (Mechanism)Cytochrome P450 2C19 Inhibitors (Mechanism)Cytochrome P450 2C9 Inhibitors (Mechanism)Cytochrome P450 3A Inducers (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)Non-Nucleoside Analog (EXT)Non-Nucleoside Reverse Transcriptase Inhibitors (Mechanism)Nucleoside Reverse Transcriptase Inhibitors (Mechanism)Nucleoside Reverse Transcriptase Inhibitors (Mechanism)Nucleosides (Chemical structure)
Identifiers: Product ID 49502-475_0a09befe-6075-4bef-bd45-0e41082559d8SPL ID 0a09befe-6075-4bef-bd45-0e41082559d8SPL set ID 81a55dd9-78a8-49c3-88ab-8f5bffafa359RxCUI 864661, 2043464UNII JE6H2O27P8, 2T8Q726O95, OTT9J7900IUPC 0349502475931
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

N449502047593 followed by a unit qualifier and the quantity

Package 49502-0475-93. 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 Oct 15, 2019. This label includes a boxed warning.

Indications (excerpt from the label)

SYMFI ® (efavirenz, lamivudine and tenofovir disoproxil fumarate) is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 40 kg. SYMFI is a three-drug combination of efavirenz (EFV), a non-nucleoside reverse transcriptase inhibitor, and lamivudine (3TC) and tenofovir disoproxil fumarate (TDF), both nucleo(t)side reverse transcriptase inhibitors and is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 40 kg. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 49502-475

What is NDC 49502-475?: 49502-475 is the product NDC for Symfi, Efavirenz 600 mg/1 + 2 more ingredients tablet, film coated, listed with the FDA by Viatris Specialty LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Symfi (Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate).
What is the active ingredient?: Efavirenz, Lamivudine, Tenofovir disoproxil fumarate.
Who is the labeler?: Viatris Specialty LLC, NDC labeler code 49502. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Symfi?: 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.