NDC 0187-5103

ELIDEL

Pimecrolimus

ELIDEL is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by Bausch Health Us, Llc. The primary component is Pimecrolimus.

• Product ID: 0187-5103_2f802a3f-c021-45c1-8693-5689c30c3fc6
• NDC: 0187-5103
• Product Type: Human Prescription Drug
• Proprietary Name: ELIDEL
• Generic Name: Pimecrolimus
• Dosage Form: Cream
• Route of Administration: TOPICAL
• Marketing Start Date: 2001-12-02
• Marketing Category: NDA / NDA
• Application Number: NDA021302
• Labeler Name: Bausch Health US, LLC
• Substance Name: PIMECROLIMUS
• Active Ingredient Strength: 10 mg/g
• Pharm Classes: Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0187-5103-04

1 TUBE in 1 CARTON (0187-5103-04) > 5 g in 1 TUBE

• Marketing Start Date: 2001-12-02
• NDC Exclude Flag: N
• Sample Package?: Y

NDC SPL Data Element Entries

NDC 0187-5103-04 [00187510304]

ELIDEL CREAM

• Marketing Category: NDA
• Application Number: NDA021302
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2001-12-02

Drug Details

Active Ingredients

Ingredient	Strength
PIMECROLIMUS	10 mg/g

OpenFDA Data

• SPL SET ID: e4027e5a-0f9b-4070-b196-f60172f45c4c
• Manufacturer:
  • Valeant Pharmaceuticals North America LLC
• UNII:
  • 7KYV510875
• RxNorm Concept Unique ID - RxCUI:
  • 352085
  • 562806

Pharmacological Class

• Calcineurin Inhibitor Immunosuppressant [EPC]
• Calcineurin Inhibitors [MoA]

NDC Crossover Matching brand name "ELIDEL" or generic name "Pimecrolimus"

NDC	Brand Name	Generic Name
0187-5100	ELIDEL	Pimecrolimus
0187-5101	ELIDEL	Pimecrolimus
0187-5102	ELIDEL	Pimecrolimus
0187-5103	ELIDEL	Pimecrolimus
0591-2944	pimecrolimus	pimecrolimus
68462-609	Pimecrolimus	Pimecrolimus
68682-110	Pimecrolimus	Pimecrolimus
68682-111	Pimecrolimus	Pimecrolimus
68682-112	Pimecrolimus	Pimecrolimus
70518-2292	pimecrolimus	pimecrolimus