NDC codes

FDA NDC Directory
Product NDC (as listed)60219-1721Labeler and product segments. Claims need a package NDC.
Product NDC at billing width60219-1721Add 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
60219-1721-76021917210760219172107120 TABLET in 1 BOTTLE, PLASTIC (60219-1721-7)Marketed from Jun 14, 2021

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)
etravirine
Generic name (nonproprietary)
etravirine
Active ingredients
Etravirine — 100 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Amneal Pharmaceuticals NY LLCNDC labeler code 60219
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 214196
Marketing start
Listing expires
Other FDA classes
Cytochrome P450 2C19 Inhibitors (Mechanism)Cytochrome P450 2C9 Inhibitors (Mechanism)Cytochrome P450 3A Inducers (Mechanism)Non-Nucleoside Analog (EXT)Non-Nucleoside Reverse Transcriptase Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
Identifiers
Product ID 60219-1721_d93c4af1-6f7d-4744-8b1e-21d89a5f5c9bSPL ID d93c4af1-6f7d-4744-8b1e-21d89a5f5c9bSPL set ID 4e009f19-4609-4020-bee1-dc27c504046cRxCUI 754761, 1052658, 1250721UNII 0C50HW4FO1UPC 0360219172074
Pharmacologic class
Human Immunodeficiency Virus 1 Non-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

N460219172107 followed by a unit qualifier and the quantity

Package 60219-1721-07. 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 .

Indications (excerpt from the label)

Etravirine tablets, in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-experienced adult patients and pediatric patients 2 years of age and older [see Microbiology (12.4) and Clinical Studies (14) ] . Etravirine is a human immunodeficiency virus type 1 (HIV-1) non-nucleoside reverse transcriptase inhibitor (NNRTI) indicated for treatment of HIV-1 infection in treatment-experienced patients 2 years of age and older. (1)

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 60219-1721

What is NDC 60219-1721?
60219-1721 is the product NDC for etravirine, Etravirine 100 mg/1 tablet, listed with the FDA by Amneal Pharmaceuticals NY LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
etravirine.
What is the active ingredient?
Etravirine.
Who is the labeler?
Amneal Pharmaceuticals NY LLC, NDC labeler code 60219. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for etravirine?
12 other product NDCs are listed under this name. See all etravirine 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 etravirine NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
etravirineEtravirine 100 mg/1TabletOralBionpharma Inc.69452-25469452-0254-22
etravirineEtravirine 200 mg/1TabletOralBionpharma Inc.69452-25569452-0255-17
EtravirineEtravirine 100 mg/1TabletOralPatriot Pharmaceuticals10147-057010147-0570-01
EtravirineEtravirine 200 mg/1TabletOralPatriot Pharmaceuticals10147-057110147-0571-01
etravirineEtravirine 100 mg/1TabletOralAvKARE42291-47342291-0473-12
etravirineEtravirine 200 mg/1TabletOralAvKARE42291-47442291-0474-60
EtravirineEtravirine 100 mg/1TabletOralCarnegie Pharmaceuticals LLC80005-11280005-0112-12
EtravirineEtravirine 200 mg/1TabletOralCarnegie Pharmaceuticals LLC80005-11380005-0113-09
EtravirineEtravirine 100 mg/1TabletOralLeading Pharma, LLC69315-28569315-0285-20
EtravirineEtravirine 200 mg/1TabletOralLeading Pharma, LLC69315-28669315-0286-06

All 13 etravirine NDCs

Other NDCs under ANDA 214196

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

FDA NDC Directory listings under ANDA 214196
ProductStrengthForm · routeLabelerProduct NDC
etravirineEtravirine 100 mg/1TabletOralAvKARE42291-473
etravirineEtravirine 200 mg/1TabletOralAvKARE42291-474
etravirineEtravirine 25 mg/1TabletOralAmneal Pharmaceuticals NY LLC60219-1720
etravirineEtravirine 200 mg/1TabletOralAmneal Pharmaceuticals NY LLC60219-1722

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