NDC 68462-609

Pimecrolimus

Pimecrolimus

Pimecrolimus is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by Glenmark Pharmaceuticals Inc., Usa. The primary component is Pimecrolimus.

• Product ID: 68462-609_ac52a235-1b6f-47a2-b3d9-8d538eeae02f
• NDC: 68462-609
• Product Type: Human Prescription Drug
• Proprietary Name: Pimecrolimus
• Generic Name: Pimecrolimus
• Dosage Form: Cream
• Route of Administration: TOPICAL
• Marketing Start Date: 2019-08-29
• Marketing Category: ANDA / ANDA
• Application Number: ANDA211769
• Labeler Name: Glenmark Pharmaceuticals Inc., USA
• 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 68462-609-35

1 TUBE in 1 CARTON (68462-609-35) > 30 g in 1 TUBE

• Marketing Start Date: 2019-08-29
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68462-609-35 [68462060935]

Pimecrolimus CREAM

• Marketing Category: ANDA
• Application Number: ANDA211769
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2019-08-29

NDC 68462-609-94 [68462060994]

Pimecrolimus CREAM

• Marketing Category: ANDA
• Application Number: ANDA211769
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2019-08-29

NDC 68462-609-65 [68462060965]

Pimecrolimus CREAM

• Marketing Category: ANDA
• Application Number: ANDA211769
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2019-08-29

Drug Details

Active Ingredients

Ingredient	Strength
PIMECROLIMUS	10 mg/g

OpenFDA Data

• SPL SET ID: ac52a235-1b6f-47a2-b3d9-8d538eeae02f
• Manufacturer:
  • Glenmark Pharmaceuticals Inc., USA
• UNII:
  • 7KYV510875
• RxNorm Concept Unique ID - RxCUI:
  • 562806
• UPC Code:
  • 0368462609354

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