What is NDC 59767-004?

59767-004 is the product NDC for Pertzye (pancrelipase), Pancrelipase lipase 4000 [USP'U]/1 + 2 more ingredients capsule, delayed release, listed with the FDA by Digestive Care, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

What is the active ingredient?

Pancrelipase lipase, Pancrelipase amylase, Pancrelipase protease.

Digestive Care, Inc., NDC labeler code 59767. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Pertzye?

3 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Pertzye NDC 59767-004 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)59767-004Labeler and product segments. Claims need a package NDC.

Product NDC at billing width59767-0004Add 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	Copy
59767-004-01	59767000401	100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59767-004-01)Marketed from Oct 6, 2016
59767-004-99	59767000499	100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59767-004-99)Marketed from Oct 6, 2016 · 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 — 4000 [USP'U]/1Pancrelipase amylase — 15125 [USP'U]/1Pancrelipase protease — 14375 [USP'U]/1
Dosage form: Capsule, Delayed release
Route: Oral
Labeler: Digestive Care, Inc.NDC labeler code 59767
Product type: Prescription drug
Marketing category: BLA — Biologics License ApplicationApplication BLA 022175
Marketing start: Oct 6, 2016
Listing expires: Dec 31, 2026
Identifiers: Product ID 59767-004_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 8MYC33932O, 3560D81V50, YOJ58O116E

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

N459767000401 followed by a unit qualifier and the quantity

Package 59767-0004-01. 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 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)

About NDC 59767-004

What is NDC 59767-004?: 59767-004 is the product NDC for Pertzye (pancrelipase), Pancrelipase lipase 4000 [USP'U]/1 + 2 more ingredients capsule, delayed release, listed with the FDA by Digestive Care, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Pertzye (Pancrelipase).
What is the active ingredient?: Pancrelipase lipase, Pancrelipase amylase, Pancrelipase protease.
Who is the labeler?: Digestive Care, Inc., NDC labeler code 59767. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Pertzye?: 3 other product NDCs are listed under this name. See all Pertzye 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 Pertzye NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Pertzyepancrelipase	Pancrelipase lipase 24000 [USP'U]/1 + 2 more ingredients	Capsule, Delayed releaseOral	Digestive Care, Inc.	59767-024	59767-0024-0059767-0024-0159767-0024-02+1 more
Pertzyepancrelipase	Pancrelipase lipase 8000 [USP'U]/1 + 2 more ingredients	Capsule, Delayed releaseOral	Digestive Care, Inc.	59767-008	59767-0008-0059767-0008-0159767-0008-02+1 more
Pertzyepancrelipase	Pancrelipase lipase 16000 [USP'U]/1 + 2 more ingredients	Capsule, Delayed releaseOral	Digestive Care, Inc.	59767-016	59767-0016-0059767-0016-0159767-0016-02+1 more

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 8000 [USP'U]/1 + 2 more ingredients	Capsule, Delayed releaseOral	Digestive Care, Inc.	59767-008
Pertzyepancrelipase	Pancrelipase lipase 16000 [USP'U]/1 + 2 more ingredients	Capsule, Delayed releaseOral	Digestive Care, Inc.	59767-016
Pertzyepancrelipase	Pancrelipase lipase 24000 [USP'U]/1 + 2 more ingredients	Capsule, Delayed releaseOral	Digestive Care, Inc.	59767-024

Pertzye (Pancrelipase) NDC 59767-004

NDC codes

Product information

Billing references

Product label

About NDC 59767-004

Other NDCs under BLA 022175

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NDC codes

Product information

Billing references

Product label

About NDC 59767-004

Related NDCs: other Pertzye products

Other NDCs under BLA 022175