15 REFERENCES
Borowitz DS, Grand RJ, Durie PR, et al. Use of pancreatic enzyme supplements for patients with cystic fibrosis in the context of fibrosing colonopathy. Journal of Pediatrics. 1995; 127: 681-684.
Borowitz DS, Baker RD, Stallings V. Consensus report on nutrition for pediatric patients with cystic fibrosis. Journal of Pediatric Gastroenterology Nutrition. 2002 Sep; 35: 246-259.
Stallings VA, Start LJ, Robinson KA, et al. Evidence-based practice recommendations for nutrition-related management of children and adults with cystic fibrosis and pancreatic insufficiency: results of a systematic review. Journal of the American Dietetic Association. 2008; 108: 832-839.
Smyth RL, Ashby D, O’Hea U, et al. Fibrosing colonopathy in cystic fibrosis: results of a case-control study.9 Lancet. 1995; 346: 1247-1251.
FitzSimmons SC, Burkhart GA, Borowitz DS, et al. High-dose pancreatic-enzyme supplements and fibrosing colonopathy in children with cystic fibrosis. New England Journal of Medicine. 1997; 336: 1283-1289

16 HOW SUPPLIED/STORAGE AND HANDLING
ZENPEP® (pancrelipase) Delayed-Release Capsules
5,000 USP units of lipase; 17,000 USP units of protease; 27,000 units of amylase.

Each ZENPEP capsule is available as a two piece hypromellose capsule with white opaque cap and white body with a blue radial print and printed with “EURAND 5”, that contains 1.8-1.9mm enteric-coated beads. Capsules are supplied in bottles of:

12 capsules (NDC 42865-100-01)
100 capsules (NDC 42865-100-02)
ZENPEP® (pancrelipase) Delayed-Release Capsules
10,000 USP units of lipase; 34,000 units of protease; 55,000 units of amylase.

Each ZENPEP capsule is available as a two piece hypromellose capsule with yellow opaque cap and white body with a blue radial print and printed with “EURAND 10”, that contains 2.2-2.5mm enteric-coated beads. Capsules are supplied in bottles of:

12 capsules (NDC 42865-101-01)
100 capsules (NDC 42865-101-02)
ZENPEP® (pancrelipase) Delayed-Release Capsules
15,000 USP units of lipase; 51,000 units of protease; 82,000 units of amylase.

Each ZENPEP capsule is available as a two piece hypromellose capsule with red opaque cap and white body with a blue radial print and printed with “EURAND 15”, that contains 2.2-2.5mm enteric-coated beads. Capsules are supplied in bottles of:

12 capsules (NDC 42865-102-01)
100 capsules (NDC 42865-102-02)
ZENPEP® (pancrelipase) Delayed-Release Capsules
20,000 USP units of lipase; 68,000 units of protease; 109,000 units of amylase.

Each ZENPEP capsule is available as a two piece hypromellose capsule with green opaque cap and white body with a blue radial print and printed with “EURAND 20”, that contains 2.2-2.5mm enteric-coated beads. Capsules are supplied in bottles of:

12 capsules (NDC 42865-103-01)
100 capsules (NDC 42865-103-02)
500 capsules (NDC 42865-103-04)

Storage and Handling:
Avoid excessive heat. Store at room temperature (68-77°F; 20-25°C), brief excursions permitted to 15-40°C (59-104°F). Protect from moisture. AFTER OPENING, KEEP BOTTLE TIGHTLY CLOSED between uses to PROTECT FROM MOISTURE.

Dispense in tight container (USP).
Keep out of reach of children.