NDC codes

FDA NDC Directory
Product NDC (as listed)61958-2506Labeler and product segments. Claims need a package NDC.
Product NDC at billing width61958-2506Add 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 NDC11-digit (billing)PackageCopy
61958-2506-1619582506016195825060130 TABLET in 1 BOTTLE, PLASTIC (61958-2506-1)Marketed from Oct 8, 2024

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
Biktarvy
Generic name (nonproprietary)
bictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate
Active ingredients
Bictegravir sodium — 30 mg/1Emtricitabine — 120 mg/1Tenofovir alafenamide fumarate — 15 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Gilead Sciences, Inc.NDC labeler code 61958
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 210251
Marketing start
Listing expires
Other FDA classes
Nucleoside Reverse Transcriptase Inhibitors (Mechanism)Nucleoside Reverse Transcriptase Inhibitors (Mechanism)Nucleosides (Chemical structure)Nucleosides (Chemical structure)
Identifiers
Product ID 61958-2506_261dcc2a-c849-46b1-abf6-4981ed2c60bcSPL ID 261dcc2a-c849-46b1-abf6-4981ed2c60bc
Pharmacologic class
Hepatitis B Virus 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

N461958250601 followed by a unit qualifier and the quantity

Package 61958-2506-01. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 61958-2506

What is NDC 61958-2506?
61958-2506 is the product NDC for Biktarvy, Bictegravir sodium 30 mg/1 + 2 more ingredients tablet, listed with the FDA by Gilead Sciences, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Biktarvy (Bictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate).
What is the active ingredient?
Bictegravir sodium, Emtricitabine, Tenofovir alafenamide fumarate.
Who is the labeler?
Gilead Sciences, Inc., NDC labeler code 61958. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Biktarvy?
3 other product NDCs are listed under this name. See all Biktarvy NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Biktarvy NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Biktarvybictegravir sodium, emtricitabine, and tenofovir alafenamide fumarateBictegravir sodium 30 mg/1 + 2 more ingredientsTabletOralGilead Sciences, Inc.61958-250561958-2505-01
Biktarvybictegravir sodium, emtricitabine, and tenofovir alafenamide fumarateBictegravir sodium 50 mg/1 + 2 more ingredientsTabletOralA-S Medication Solutions50090-624750090-6247-00
Biktarvybictegravir sodium, emtricitabine, and tenofovir alafenamide fumarateBictegravir sodium 50 mg/1 + 2 more ingredientsTabletOralGilead Sciences, Inc.61958-250161958-2501-0161958-2501-0261958-2501-03+1 more

Other NDCs under NDA 210251

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 210251
ProductStrengthForm · routeLabelerProduct NDC
Biktarvybictegravir sodium, emtricitabine, and tenofovir alafenamide fumarateBictegravir sodium 50 mg/1 + 2 more ingredientsTabletOralA-S Medication Solutions50090-6247
Biktarvybictegravir sodium, emtricitabine, and tenofovir alafenamide fumarateBictegravir sodium 50 mg/1 + 2 more ingredientsTabletOralGilead Sciences, Inc.61958-2501
Biktarvybictegravir sodium, emtricitabine, and tenofovir alafenamide fumarateBictegravir sodium 30 mg/1 + 2 more ingredientsTabletOralGilead Sciences, Inc.61958-2505

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