Unfinished product

This listing is a drug for further processing, not a finished drug product dispensed or administered to patients. It is not normally billed.

NDC codes

FDA NDC Directory
Product NDC (as listed)65862-354Labeler and product segments. Claims need a package NDC.
Product NDC at billing width65862-0354Add 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
65862-354-1565862035415658620354151500 TABLET, FILM COATED in 1 BAG (65862-354-15)Marketed from 30-MAR-21

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

Generic name (nonproprietary)
emtricitabine and tenofovir disoproxil fumarate
Active ingredients
Emtricitabine — 200 mg/1Tenofovir disoproxil fumarate — 300 mg/1
Dosage form
Tablet, Film coated
Labeler
Aurobindo Pharma LimitedNDC labeler code 65862
Product type
Drug for further processing
Marketing category
Drug for further processing
Marketing start
Listing expires
Identifiers
Product ID 65862-354_28103c1d-82ed-41cc-9c24-366f73e796c2SPL ID 28103c1d-82ed-41cc-9c24-366f73e796c2

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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N465862035415 followed by a unit qualifier and the quantity

Package 65862-0354-15. 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 65862-354

What is NDC 65862-354?
65862-354 is the product NDC for Emtricitabine and Tenofovir Disoproxil Fumarate, Emtricitabine 200 mg/1; Tenofovir disoproxil fumarate 300 mg/1 tablet, film coated, listed with the FDA by Aurobindo Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Emtricitabine and Tenofovir Disoproxil Fumarate.
What is the active ingredient?
Emtricitabine, Tenofovir disoproxil fumarate.
Who is the labeler?
Aurobindo Pharma Limited, NDC labeler code 65862. 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 and Tenofovir Disoproxil Fumarate?
42 other product NDCs are listed under this name. See all Emtricitabine and Tenofovir Disoproxil Fumarate 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 Emtricitabine and Tenofovir Disoproxil Fumarate NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Emtricitabine and Tenofovir Disoproxil FumarateEmtricitabine 200 mg/1; Tenofovir disoproxil fumarate 300 mg/1Tablet, Film coatedOralAvKARE42291-98042291-0980-30
Emtricitabine and Tenofovir Disoproxil FumarateEmtricitabine 200 mg/1; Tenofovir disoproxil fumarate 300 mg/1Tablet, Film coatedOralQUALLENT PHARMACEUTICALS HEALTH LLC82009-10982009-0109-30
Emtricitabine and Tenofovir Disoproxil FumarateEmtricitabine 100 mg/1; Tenofovir disoproxil fumarate 150 mg/1Tablet, Film coatedOralAurobindo Pharma Limited59651-16559651-0165-30
Emtricitabine and Tenofovir Disoproxil FumarateEmtricitabine 133 mg/1; Tenofovir disoproxil fumarate 200 mg/1Tablet, Film coatedOralAurobindo Pharma Limited59651-16659651-0166-30
Emtricitabine and Tenofovir Disoproxil FumarateEmtricitabine 167 mg/1; Tenofovir disoproxil fumarate 250 mg/1Tablet, Film coatedOralAurobindo Pharma Limited59651-16759651-0167-30
Emtricitabine and tenofovir disoproxil fumarateEmtricitabine 200 mg/1; Tenofovir disoproxil fumarate 300 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-802850090-8028-01
Emtricitabine and tenofovir disoproxil fumarateEmtricitabine 200 mg/1; Tenofovir disoproxil fumarate 300 mg/1Tablet, Film coatedOralNorthStar RxLLC16714-53416714-0534-01
Emtricitabine and tenofovir disoproxil fumarateEmtricitabine 200 mg/1; Tenofovir disoproxil fumarate 300 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals, Inc.68071-369568071-3695-03
Emtricitabine And Tenofovir Disoproxil FumarateEmtricitabine 200 mg/1; Tenofovir disoproxil fumarate 300 mg/1Tablet, Film coatedOralDirectRx72189-31272189-0312-03
Emtricitabine And Tenofovir Disoproxil FumarateEmtricitabine 200 mg/1; Tenofovir disoproxil fumarate 300 mg/1Tablet, Film coatedOralCipla USA Inc.69097-74169097-0741-02

All 43 Emtricitabine and Tenofovir Disoproxil Fumarate NDCs

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