NDC codes

FDA NDC Directory
Product NDC (as listed)16714-717Labeler and product segments. Claims need a package NDC.
Product NDC at billing width16714-0717Add 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
16714-717-01167140717011671407170130 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16714-717-01)Marketed from Jun 15, 2017

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 — .5 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
NorthStar RxLLCNDC labeler code 16714
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 206872
Marketing start
Listing expires
Other FDA classes
Nucleoside Analog (EXT)Nucleoside Reverse Transcriptase Inhibitors (Mechanism)
Identifiers
Product ID 16714-717_3e6a4c6c-0a9e-4ffd-b8e0-853bbfa961a9SPL ID 3e6a4c6c-0a9e-4ffd-b8e0-853bbfa961a9SPL set ID da705339-c349-444f-a058-4f0cef2864bfRxCUI 485434, 485436UNII 5968Y6H45M
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

N416714071701 followed by a unit qualifier and the quantity

Package 16714-0717-01. 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)

Entecavir tablet is a hepatitis B virus nucleoside analogue reverse transcriptase inhibitor indicated for the treatment of chronic hepatitis B virus infection in adults and children at least 2 years of age with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease. ( 1 ) Entecavir tablet is indicated for the treatment of chronic hepatitis B virus infection in adults and pediatric patients 2 years of age and older with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 16714-717

What is NDC 16714-717?
16714-717 is the product NDC for Entecavir, Entecavir .5 mg/1 tablet, film coated, listed with the FDA by NorthStar RxLLC. 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?
NorthStar RxLLC, NDC labeler code 16714. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Entecavirentecavir anhydrousEntecavir anhydrous .5 mg/1TabletOralCameron Pharmaceuticals42494-45742494-0457-30
Entecavirentecavir anhydrousEntecavir anhydrous 1 mg/1TabletOralCameron Pharmaceuticals42494-45842494-0458-30
EntecavirEntecavir .5 mg/1Tablet, Film coatedOralYaopharma Co., Ltd.50771-01350771-0013-0150771-0013-02
EntecavirEntecavir 1 mg/1Tablet, Film coatedOralYaopharma Co., Ltd.50771-01450771-0014-01
EntecavirEntecavir anhydrous .5 mg/1Tablet, Film coatedOralEpic Pharma, LLC42806-66742806-0667-30
EntecavirEntecavir anhydrous 1 mg/1Tablet, Film coatedOralEpic Pharma, LLC42806-66842806-0668-30
EntecavirEntecavir .5 mg/1TabletOralGolden State Medical Supply, Inc.51407-58951407-0589-30
EntecavirEntecavir .5 mg/1TabletOralCarlsbad Technology, Inc.61442-31161442-0311-30
EntecavirEntecavir .5 mg/1Tablet, Film coatedOralAvKARE42291-26142291-0261-30
EntecavirEntecavir .5 mg/1TabletOralEPIC PHARMA, LLC42806-65842806-0658-30

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
ProductStrengthForm · routeLabelerProduct NDC
EntecavirEntecavir 1 mg/1Tablet, Film coatedOralNorthStar RxLLC16714-718
EntecavirEntecavir 1 mg/1Tablet, Film coatedOralCipla USA Inc.69097-425
EntecavirEntecavir .5 mg/1Tablet, Film coatedOralCipla USA Inc.69097-426

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