NDC codes

FDA NDC Directory
Product NDC (as listed)50090-6247Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50090-6247Add 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
50090-6247-0500906247005009062470030 TABLET in 1 BOTTLE, PLASTIC (50090-6247-0)Marketed from Nov 28, 2022

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 — 50 mg/1Emtricitabine — 200 mg/1Tenofovir alafenamide fumarate — 25 mg/1
Dosage form
Tablet
Route
Oral
Labeler
A-S Medication SolutionsNDC labeler code 50090
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 50090-6247_a3c4a0eb-71e8-4b35-9706-240874b78ee0SPL ID a3c4a0eb-71e8-4b35-9706-240874b78ee0SPL set ID 0476d7eb-1024-4821-bbe7-abaacfda32a2RxCUI 1999667, 1999673UNII 4L5MP1Y7W7, G70B4ETF4S, FWF6Q91TZO
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

N450090624700 followed by a unit qualifier and the quantity

Package 50090-6247-00. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

BIKTARVY is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients weighing at least 14 kg: who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no known or suspected substitutions associated with resistance to bictegravir or tenofovir. BIKTARVY is a three-drug combination of bictegravir (BIC), a human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI), and emtricitabine (FTC) and tenofovir alafenamide (TAF), both HIV-…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 50090-6247

What is NDC 50090-6247?
50090-6247 is the product NDC for Biktarvy, Bictegravir sodium 50 mg/1 + 2 more ingredients tablet, listed with the FDA by A-S Medication Solutions. 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?
A-S Medication Solutions, NDC labeler code 50090. 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.61958-250661958-2506-01
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 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 ingredientsTabletOralGilead Sciences, Inc.61958-2501
Biktarvybictegravir sodium, emtricitabine, and tenofovir alafenamide fumarateBictegravir sodium 30 mg/1 + 2 more ingredientsTabletOralGilead Sciences, Inc.61958-2505
Biktarvybictegravir sodium, emtricitabine, and tenofovir alafenamide fumarateBictegravir sodium 30 mg/1 + 2 more ingredientsTabletOralGilead Sciences, Inc.61958-2506

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