What is NDC 69097-425?

69097-425 is the product NDC for Entecavir, Entecavir 1 mg/1 tablet, film coated, listed with the FDA by Cipla USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

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 Entecavir?

27 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Entecavir NDC 69097-425 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)69097-425Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69097-0425Add 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 NDC	11-digit (billing)	Package	Copy
69097-425-02	6909704250269097042502	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69097-425-02)Marketed from Dec 6, 2016

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): Entecavir
Generic name (nonproprietary): entecavir
Active ingredients: Entecavir — 1 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Cipla USA Inc.NDC labeler code 69097
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 206872
Marketing start: Dec 6, 2016
Listing expires: Dec 31, 2027
Other FDA classes: Nucleoside Analog (EXT)Nucleoside Reverse Transcriptase Inhibitors (Mechanism)
Identifiers: Product ID 69097-425_6766d9ae-3639-4bc7-9488-5bf52fe49420SPL ID 6766d9ae-3639-4bc7-9488-5bf52fe49420
Pharmacologic class: Hepatitis B 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

N469097042502 followed by a unit qualifier and the quantity

Package 69097-0425-02. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 69097-425

What is NDC 69097-425?: 69097-425 is the product NDC for Entecavir, Entecavir 1 mg/1 tablet, film coated, 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?: Entecavir.
What is the active ingredient?: Entecavir.
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 Entecavir?: 27 other product NDCs are listed under this name. See all Entecavir 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 Entecavir NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Entecavirentecavir anhydrous	Entecavir anhydrous .5 mg/1	TabletOral	Cameron Pharmaceuticals	42494-457	42494-0457-30
Entecavirentecavir anhydrous	Entecavir anhydrous 1 mg/1	TabletOral	Cameron Pharmaceuticals	42494-458	42494-0458-30
Entecavir	Entecavir .5 mg/1	Tablet, Film coatedOral	Yaopharma Co., Ltd.	50771-013	50771-0013-0150771-0013-02
Entecavir	Entecavir 1 mg/1	Tablet, Film coatedOral	Yaopharma Co., Ltd.	50771-014	50771-0014-01
Entecavir	Entecavir anhydrous .5 mg/1	Tablet, Film coatedOral	Epic Pharma, LLC	42806-667	42806-0667-30
Entecavir	Entecavir anhydrous 1 mg/1	Tablet, Film coatedOral	Epic Pharma, LLC	42806-668	42806-0668-30
Entecavir	Entecavir .5 mg/1	TabletOral	Golden State Medical Supply, Inc.	51407-589	51407-0589-30
Entecavir	Entecavir .5 mg/1	TabletOral	Carlsbad Technology, Inc.	61442-311	61442-0311-30
Entecavir	Entecavir .5 mg/1	Tablet, Film coatedOral	AvKARE	42291-261	42291-0261-30
Entecavir	Entecavir .5 mg/1	TabletOral	EPIC PHARMA, LLC	42806-658	42806-0658-30

All 28 Entecavir NDCs

Other NDCs under ANDA 206872

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

FDA NDC Directory listings under ANDA 206872
Product	Strength	Form · route	Labeler	Product NDC
Entecavir	Entecavir .5 mg/1	Tablet, Film coatedOral	NorthStar RxLLC	16714-717
Entecavir	Entecavir 1 mg/1	Tablet, Film coatedOral	NorthStar RxLLC	16714-718
Entecavir	Entecavir .5 mg/1	Tablet, Film coatedOral	Cipla USA Inc.	69097-426