NDC codes

FDA NDC Directory
Product NDC (as listed)42806-658Labeler and product segments. Claims need a package NDC.
Product NDC at billing width42806-0658Add 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
42806-658-30428060658304280606583030 TABLET in 1 BOTTLE, PLASTIC (42806-658-30)Marketed from Jun 2, 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)
Entecavir
Generic name (nonproprietary)
entecavir
Active ingredients
Entecavir — .5 mg/1
Dosage form
Tablet
Route
Oral
Labeler
EPIC PHARMA, LLCNDC labeler code 42806
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 212126
Marketing start
Listing expires
Other FDA classes
Nucleoside Analog (EXT)Nucleoside Reverse Transcriptase Inhibitors (Mechanism)
Identifiers
Product ID 42806-658_db290579-c9e1-44be-b03c-ad8a7efe5ce1SPL ID db290579-c9e1-44be-b03c-ad8a7efe5ce1SPL set ID af4f47e2-f556-40f2-a0fd-ff81e9f27429RxCUI 485434, 485436UNII 5968Y6H45MUPC 0342806658307, 0342806659304
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

N442806065830 followed by a unit qualifier and the quantity

Package 42806-0658-30. 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 tablets are 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. Entecavir 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)

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 42806-658

What is NDC 42806-658?
42806-658 is the product NDC for Entecavir, Entecavir .5 mg/1 tablet, listed with the FDA by EPIC PHARMA, LLC. 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?
EPIC PHARMA, LLC, NDC labeler code 42806. 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 1 mg/1TabletOralEPIC PHARMA, LLC42806-65942806-0659-30

All 28 Entecavir NDCs

Other NDCs under ANDA 212126

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

FDA NDC Directory listings under ANDA 212126
ProductStrengthForm · routeLabelerProduct NDC
EntecavirEntecavir 1 mg/1TabletOralEPIC PHARMA, LLC42806-659

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