Pertzye (pancrelipase) NDC 59767-016

NDC codes

FDA NDC Directory

Product NDC (as listed)59767-016Labeler and product segments. Claims need a package NDC.

Product NDC at billing width59767-0016Add 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
59767-016-00	59767001600	20 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59767-016-00)Marketed from Jan 23, 2014 · Sample package
59767-016-01	59767001601	100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59767-016-01)Marketed from May 17, 2012
59767-016-02	59767001602	250 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59767-016-02)Marketed from May 17, 2012
59767-016-99	59767001699	100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59767-016-99)Marketed from May 17, 2012 · Sample package

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): Pertzye
Generic name (nonproprietary): pancrelipase
Active ingredients: Pancrelipase lipase — 16000 [USP'U]/1Pancrelipase amylase — 60500 [USP'U]/1Pancrelipase protease — 57500 [USP'U]/1
Dosage form: Capsule, Delayed release
Route: Oral
Labeler: Digestive Care, Inc.
Product type: Prescription drug
Marketing category: BLA — Biologics License ApplicationApplication BLA 022175
Marketing start: May 17, 2012
Listing expires: Dec 31, 2026
Identifiers: Product ID 59767-016_2ae80639-0555-49c6-bae7-00f43983e614SPL ID 2ae80639-0555-49c6-bae7-00f43983e614SPL set ID 481eec00-9abf-11dd-b71c-0002a5d5c51bRxCUI 1294122, 1294128, 1294481, 1294483, 1543004, 1543006, 1929116, 1929118UNII YOJ58O116E, 3560D81V50, 8MYC33932O

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

N459767001600 followed by a unit qualifier and the quantity

Package 59767-0016-00. 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 Mar 11, 2024.

Indications (excerpt from the label)

PERTZYE ® is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients. PERTZYE ® is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under BLA 022175

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

FDA NDC Directory listings under BLA 022175
Product	Strength	Form · route	Labeler	Product NDC
Pertzyepancrelipase	Pancrelipase lipase 24000 [USP'U]/1 + 2 more ingredients	Capsule, Delayed releaseOral	Digestive Care, Inc.	59767-024
Pertzyepancrelipase	Pancrelipase lipase 4000 [USP'U]/1 + 2 more ingredients	Capsule, Delayed releaseOral	Digestive Care, Inc.	59767-004
Pertzyepancrelipase	Pancrelipase lipase 8000 [USP'U]/1 + 2 more ingredients	Capsule, Delayed releaseOral	Digestive Care, Inc.	59767-008