NDC 0591-2944

pimecrolimus

Pimecrolimus

pimecrolimus is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by Actavis Pharma, Inc.. The primary component is Pimecrolimus.

• Product ID: 0591-2944_a3f0bc92-796c-4f74-8c7a-63001b4e9e43
• NDC: 0591-2944
• Product Type: Human Prescription Drug
• Proprietary Name: pimecrolimus
• Generic Name: Pimecrolimus
• Dosage Form: Cream
• Route of Administration: TOPICAL
• Marketing Start Date: 2018-12-27
• Marketing Category: ANDA / ANDA
• Application Number: ANDA209345
• Labeler Name: Actavis Pharma, Inc.
• 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: 2020-12-31

Packaging

NDC 0591-2944-30

30 g in 1 TUBE (0591-2944-30)

• Marketing Start Date: 2018-12-27
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0591-2944-30 [00591294430]

pimecrolimus CREAM

• Marketing Category: ANDA
• Application Number: ANDA209345
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2018-12-27

NDC 0591-2944-87 [00591294487]

pimecrolimus CREAM

• Marketing Category: ANDA
• Application Number: ANDA209345
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2018-12-27

NDC 0591-2944-60 [00591294460]

pimecrolimus CREAM

• Marketing Category: ANDA
• Application Number: ANDA209345
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2018-12-27

Drug Details

Active Ingredients

Ingredient	Strength
PIMECROLIMUS	10 mg/g

OpenFDA Data

• SPL SET ID: d5b0403a-065f-42e3-96d6-7dcb9ab127d3
• Manufacturer:
  • Actavis Pharma, Inc.
• UNII:
  • 7KYV510875
• RxNorm Concept Unique ID - RxCUI:
  • 562806

Pharmacological Class

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

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

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