Prescription drug · BLA
Pertzye (Pancrelipase) NDC 59767-016
Pancrelipase lipase 16000 [USP'U]/1 + 2 more ingredients · Capsule, Delayed release · Oral · Digestive Care, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 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.NDC labeler code 59767
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 022175
- Marketing start
- Listing expires
- 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 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
N459767001600followed by a unit qualifier and the quantityPackage 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 .
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.
About NDC 59767-016
- What is NDC 59767-016?
- 59767-016 is the product NDC for Pertzye (pancrelipase), Pancrelipase lipase 16000 [USP'U]/1 + 2 more ingredients capsule, delayed release, listed with the FDA by Digestive Care, Inc.. It has 4 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.
Related NDCs: other Pertzye products
Other finished products listed under the same name: strengths, forms and labelers.
| 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 4000 [USP'U]/1 + 2 more ingredients | Capsule, Delayed releaseOral | Digestive Care, Inc. | 59767-004 | 59767-0004-0159767-0004-99 |
| 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 |
Other NDCs under BLA 022175
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| 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 |
| Pertzyepancrelipase | Pancrelipase lipase 24000 [USP'U]/1 + 2 more ingredients | Capsule, Delayed releaseOral | Digestive Care, Inc. | 59767-024 |