NDC codes

FDA NDC Directory
Product NDC (as listed)0006-3074Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00006-3074Add 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
0006-3074-02000063074022 DOSE PACK in 1 CARTON (0006-3074-02) / 14 TABLET, FILM COATED in 1 DOSE PACK (0006-3074-01)Marketed from Jan 28, 2016

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
Zepatier
Generic name (nonproprietary)
elbasvir and grazoprevir
Active ingredients
Elbasvir — 50 mg/1Grazoprevir anhydrous — 100 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Merck Sharp & Dohme LLCNDC labeler code 0006
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 208261
Marketing start
Listing expires
Other FDA classes
Breast Cancer Resistance Protein Inhibitors (Mechanism)Breast Cancer Resistance Protein Inhibitors (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)HCV NS3/4A Protease Inhibitors (Mechanism)
Identifiers
Product ID 0006-3074_227ae348-5f6f-44d8-a6dc-103e63d28102SPL ID 227ae348-5f6f-44d8-a6dc-103e63d28102SPL set ID 164dc02a-9180-426a-b8b5-04ab39d2bbd4RxCUI 1734636, 1734642UNII 632L571YDK, 8YE81R1X1J
Pharmacologic class
Hepatitis C Virus NS3/4A Protease Inhibitor; Hepatitis C Virus NS5A 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

N400006307402 followed by a unit qualifier and the quantity

Package 00006-3074-02. 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)

ZEPATIER ® is indicated for the treatment of chronic hepatitis C virus (HCV) genotype 1 or 4 infection in adult and pediatric patients 12 years of age and older or weighing at least 30 kg. ZEPATIER is indicated for use with ribavirin in certain patient populations [see Dosage and Administration (2.2) ] . ZEPATIER is a fixed-dose combination product containing elbasvir, a hepatitis C virus (HCV) NS5A inhibitor, and grazoprevir, an HCV NS3/4A protease inhibitor, and is indicated for treatment of chronic HCV genotype 1 or 4 infection in adult and pediatric patients 12 years of age and older or weighing at least 30 kg. ZEPATIER is indicated for use with ribavirin in certain patient populations. …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0006-3074

What is NDC 0006-3074?
0006-3074 is the product NDC for Zepatier, Elbasvir 50 mg/1; Grazoprevir anhydrous 100 mg/1 tablet, film coated, listed with the FDA by Merck Sharp & Dohme LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Zepatier (Elbasvir and grazoprevir).
What is the active ingredient?
Elbasvir, Grazoprevir anhydrous.
Who is the labeler?
Merck Sharp & Dohme LLC, NDC labeler code 0006. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Zepatier?
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.

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