NDC codes

FDA NDC Directory
Product NDC (as listed)61958-0705Labeler and product segments. Claims need a package NDC.
Product NDC at billing width61958-0705Add 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
61958-0705-1619580705016195807050130 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-0705-1)Marketed from Mar 10, 2016

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)
Truvada
Generic name (nonproprietary)
emtricitabine and tenofovir disoproxil fumarate
Active ingredients
Emtricitabine — 167 mg/1Tenofovir disoproxil fumarate — 250 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Gilead Sciences, IncNDC labeler code 61958
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 021752
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 61958-0705_32422ee8-1cdc-4305-bb3e-0458472513fcSPL ID 32422ee8-1cdc-4305-bb3e-0458472513fcSPL set ID 54e82b13-a037-49ed-b4b3-030b37c0ecddRxCUI 476556, 639888, 1744001, 1744003, 1744005, 1744007, 1744009, 1744011UNII G70B4ETF4S, OTT9J7900I
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

N461958070501 followed by a unit qualifier and the quantity

Package 61958-0705-01. 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

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

Indications (excerpt from the label)

HIV-1 Treatment ( 1.1 ) TRUVADA is a two-drug combination of emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF), both HIV-1 nucleoside analog reverse transcriptase inhibitors, and is indicated: in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 17 kg. HIV-1 PrEP ( 1.2 ): TRUVADA is indicated in at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection. Individuals must have a negative HIV-1 test immediately prior to initiating TRUVADA for HIV-1 PrEP. 1.1 Treatment of HIV-1 Infection TRUVADA is indicated in combi…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 61958-0705

What is NDC 61958-0705?
61958-0705 is the product NDC for Truvada, Emtricitabine 167 mg/1; Tenofovir disoproxil fumarate 250 mg/1 tablet, film coated, 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?
Truvada (Emtricitabine and tenofovir disoproxil fumarate).
What is the active ingredient?
Emtricitabine, Tenofovir disoproxil 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 Truvada?
4 other product NDCs are listed under this name. See all Truvada 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 Truvada NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Truvadaemtricitabine and tenofovir disoproxil fumarateEmtricitabine 100 mg/1; Tenofovir disoproxil fumarate 150 mg/1Tablet, Film coatedOralGilead Sciences, Inc61958-070361958-0703-01
Truvadaemtricitabine and tenofovir disoproxil fumarateEmtricitabine 133 mg/1; Tenofovir disoproxil fumarate 200 mg/1Tablet, Film coatedOralGilead Sciences, Inc61958-070461958-0704-01
Truvadaemtricitabine and tenofovir disoproxil fumarateEmtricitabine 200 mg/1; Tenofovir disoproxil fumarate 300 mg/1Tablet, Film coatedOralGilead Sciences, Inc61958-070161958-0701-01
Truvadaemtricitabine and tenofovir disoproxil fumarateEmtricitabine 200 mg/1; Tenofovir disoproxil fumarate 300 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-211268071-2112-03

Other NDCs under NDA 021752

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

FDA NDC Directory listings under NDA 021752
ProductStrengthForm · routeLabelerProduct NDC
Truvadaemtricitabine and tenofovir disoproxil fumarateEmtricitabine 200 mg/1; Tenofovir disoproxil fumarate 300 mg/1Tablet, Film coatedOralGilead Sciences, Inc61958-0701
Truvadaemtricitabine and tenofovir disoproxil fumarateEmtricitabine 100 mg/1; Tenofovir disoproxil fumarate 150 mg/1Tablet, Film coatedOralGilead Sciences, Inc61958-0703
Truvadaemtricitabine and tenofovir disoproxil fumarateEmtricitabine 133 mg/1; Tenofovir disoproxil fumarate 200 mg/1Tablet, Film coatedOralGilead Sciences, Inc61958-0704
Truvadaemtricitabine and tenofovir disoproxil fumarateEmtricitabine 200 mg/1; Tenofovir disoproxil fumarate 300 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-2112

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