NDC codes

FDA NDC Directory
Product NDC (as listed)70771-1019Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70771-1019Add 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
70771-1019-17077110190170771101901100 TABLET, FILM COATED in 1 BOTTLE (70771-1019-1)Marketed from Aug 10, 2017
70771-1019-3707711019037077110190330 TABLET, FILM COATED in 1 BOTTLE (70771-1019-3)Marketed from Aug 10, 2017
70771-1019-4707711019047077110190410 BLISTER PACK in 1 CARTON (70771-1019-4) / 10 TABLET, FILM COATED in 1 BLISTER PACK (70771-1019-2)Marketed from Aug 10, 2017
70771-1019-9707711019097077110190990 TABLET, FILM COATED in 1 BOTTLE (70771-1019-9)Marketed from Aug 10, 2017

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)
Entecavir
Generic name (nonproprietary)
entecavir
Active ingredients
Entecavir — .5 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Zydus Lifesciences LimitedNDC labeler code 70771
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 206745
Marketing start
Listing expires
Other FDA classes
Nucleoside Analog (EXT)Nucleoside Reverse Transcriptase Inhibitors (Mechanism)
Identifiers
Product ID 70771-1019_eb274d01-4108-4d2e-8e2b-8656b90684c0SPL ID eb274d01-4108-4d2e-8e2b-8656b90684c0SPL set ID 0e3b2a0a-9076-4907-bbaf-eb6a65bb9481RxCUI 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

N470771101901 followed by a unit qualifier and the quantity

Package 70771-1019-01. 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 .

Full label on DailyMed (opens in a new tab)

About NDC 70771-1019

What is NDC 70771-1019?
70771-1019 is the product NDC for Entecavir, Entecavir .5 mg/1 tablet, film coated, listed with the FDA by Zydus Lifesciences Limited. It has 4 package NDCs, 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?
Zydus Lifesciences Limited, NDC labeler code 70771. 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 206745

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

FDA NDC Directory listings under ANDA 206745
ProductStrengthForm · routeLabelerProduct NDC
EntecavirEntecavir .5 mg/1Tablet, Film coatedOralZydus Pharmaceuticals USA Inc.68382-920
EntecavirEntecavir 1 mg/1Tablet, Film coatedOralZydus Pharmaceuticals USA Inc.68382-921
EntecavirEntecavir 1 mg/1Tablet, Film coatedOralZydus Lifesciences Limited70771-1020

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