NDC codes

FDA NDC Directory
Product NDC (as listed)69097-642Labeler and product segments. Claims need a package NDC.
Product NDC at billing width69097-0642Add 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
69097-642-02690970642026909706420230 CAPSULE in 1 BOTTLE (69097-642-02)Marketed from Aug 31, 2020

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

Brand name (proprietary)
emtricitabine
Generic name (nonproprietary)
emtricitabine
Active ingredients
Emtricitabine — 200 mg/1
Dosage form
Capsule
Route
Oral
Labeler
Cipla USA Inc.NDC labeler code 69097
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 091168
Marketing start
Listing expires
Other FDA classes
Nucleoside Reverse Transcriptase Inhibitors (Mechanism)Nucleosides (Chemical structure)
Identifiers
Product ID 69097-642_f4575438-cafb-44c7-b35a-25e87792a85fSPL ID f4575438-cafb-44c7-b35a-25e87792a85fSPL set ID a229c922-58eb-4795-9219-6cebb1779e35RxCUI 403875UNII G70B4ETF4S
Pharmacologic class
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

N469097064202 followed by a unit qualifier and the quantity

Package 69097-0642-02. 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)

Emtricitabine is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. Emtricitabine, a nucleoside analog HIV-1 reverse transcriptase inhibitor, is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 69097-642

What is NDC 69097-642?
69097-642 is the product NDC for emtricitabine, Emtricitabine 200 mg/1 capsule, listed with the FDA by Cipla USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
emtricitabine.
What is the active ingredient?
Emtricitabine.
Who is the labeler?
Cipla USA Inc., NDC labeler code 69097. 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?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Free account

Log in to keep searching

You’ve used your 3 free searches. Med-Code is free: log in or create a free profile to keep looking up NDCs, J-codes and drugs.

Create a free profileLog in