NDC 0168-0432

imiquimod

Imiquimod

imiquimod is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by E. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.. The primary component is Imiquimod.

• Product ID: 0168-0432_fdbbf340-e87c-44ed-9274-148846ffd788
• NDC: 0168-0432
• Product Type: Human Prescription Drug
• Proprietary Name: imiquimod
• Generic Name: Imiquimod
• Dosage Form: Cream
• Route of Administration: TOPICAL
• Marketing Start Date: 2010-02-25
• Marketing Category: ANDA / ANDA
• Application Number: ANDA078548
• Labeler Name: E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
• Substance Name: IMIQUIMOD
• Active Ingredient Strength: 50 mg/g
• Pharm Classes: Increased Cytokine Activity [PE],Increased Cytokine Production [PE],Interferon Inducers [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0168-0432-24

24 PACKET in 1 BOX (0168-0432-24) > .25 g in 1 PACKET (0168-0432-27)

• Marketing Start Date: 2010-02-25
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0168-0432-27 [00168043227]

imiquimod CREAM

• Marketing Category: ANDA
• Application Number: ANDA078548
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2010-02-25

NDC 0168-0432-24 [00168043224]

imiquimod CREAM

• Marketing Category: ANDA
• Application Number: ANDA078548
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2010-02-25

Drug Details

Active Ingredients

Ingredient	Strength
IMIQUIMOD	50 mg/g

OpenFDA Data

• SPL SET ID: a1dfc325-cc63-4347-9497-f6baf874963c
• Manufacturer:
  • E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
• UNII:
  • P1QW714R7M
• RxNorm Concept Unique ID - RxCUI:
  • 310982

Pharmacological Class

• Increased Cytokine Activity [PE]
• Increased Cytokine Production [PE]
• Interferon Inducers [MoA]
• Increased Cytokine Activity [PE]
• Increased Cytokine Production [PE]
• Interferon Inducers [MoA]

NDC Crossover Matching brand name "imiquimod" or generic name "Imiquimod"

NDC	Brand Name	Generic Name
0093-3133	Imiquimod	imiquimod
0168-0432	imiquimod	imiquimod
45802-368	Imiquimod	Imiquimod
51672-4145	Imiquimod	Imiquimod
51672-4174	Imiquimod	Imiquimod
52549-4145	Imiquimod	Imiquimod
63629-8818	Imiquimod	imiquimod
64380-773	imiquimod	imiquimod
68462-536	Imiquimod	Imiquimod
68682-272	Imiquimod	imiquimod
72189-084	IMIQUIMOD	IMIQUIMOD
99207-260	Aldara	imiquimod
99207-270	Zyclara	imiquimod
99207-271	Zyclara	imiquimod
99207-276	Zyclara	imiquimod