Pancreaze NDC 62541-403

NDC codes

FDA NDC Directory

Product NDC (as listed)62541-403Labeler and product segments. Claims need a package NDC.

Product NDC at billing width62541-0403Add 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
62541-403-10	62541040310	1 BOTTLE, GLASS in 1 CARTON (62541-403-10) / 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE, GLASSMarketed from Apr 12, 2010

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): Pancreaze
Generic name (nonproprietary): pancrelipase lipase, pancrelipase amylase, and pancrelipase protease
Active ingredients: Pancrelipase lipase — 10500 [USP'U]/1Pancrelipase amylase — 61500 [USP'U]/1Pancrelipase protease — 35500 [USP'U]/1
Dosage form: Capsule, Delayed release
Route: Oral
Labeler: VIVUS LLC
Product type: Prescription drug
Marketing category: BLA — Biologics License ApplicationApplication BLA 022523
Marketing start: Apr 12, 2010
Listing expires: Dec 31, 2026
Identifiers: Product ID 62541-403_36e934b1-3fbb-8f0c-e063-6294a90a968cSPL ID 36e934b1-3fbb-8f0c-e063-6294a90a968cSPL set ID e8f5d2fe-728d-42af-99a6-83dddc6539c5RxCUI 1806919, 1806921, 1806924, 1806926, 1806929, 1806931, 1806964, 1806966, 2478453, 2478455, 2564410, 2564412UNII YOJ58O116E, 3560D81V50, 8MYC33932OUPC 0362541402102, 0362541403109, 0362541405103, 0362541401105, 0362541406100, 0362541404106

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

N462541040310 followed by a unit qualifier and the quantity

Package 62541-0403-10. 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 Jun 6, 2025.

Indications (excerpt from the label)

PANCREAZE is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients. PANCREAZE ® 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 022523

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

FDA NDC Directory listings under BLA 022523
Product	Strength	Form · route	Labeler	Product NDC
Pancreazepancrelipase lipase, pancrelipase amylase, and pancrelipase protease	Pancrelipase lipase 16800 [USP'U]/1 + 2 more ingredients	Capsule, Delayed releaseOral	VIVUS LLC	62541-404
Pancreazepancrelipase lipase, pancrelipase amylase, and pancrelipase protease	Pancrelipase lipase 2600 [USP'U]/1 + 2 more ingredients	Capsule, Delayed releaseOral	VIVUS LLC	62541-401
Pancreazepancrelipase lipase, pancrelipase amylase, and pancrelipase protease	Pancrelipase lipase 4200 [USP'U]/1 + 2 more ingredients	Capsule, Delayed releaseOral	VIVUS LLC	62541-402
Pancreazepancrelipase lipase, pancrelipase amylase, and pancrelipase protease	Pancrelipase lipase 21000 [USP'U]/1 + 2 more ingredients	Capsule, Delayed releaseOral	VIVUS LLC	62541-405
Pancreazepancrelipase lipase, pancrelipase amylase, and pancrelipase protease	Pancrelipase lipase 37000 [USP'U]/1 + 2 more ingredients	Capsule, Delayed releaseOral	VIVUS LLC	62541-406