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NDC 45802-0368-53 Imiquimod 12.5 mg/.25g Details
Imiquimod 12.5 mg/.25g
Imiquimod is a TOPICAL CREAM in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Padagis Israel Pharmaceuticals Ltd. The primary component is IMIQUIMOD.
MedlinePlus Drug Summary
Imiquimod cream is used to treat certain types of actinic keratoses (flat, scaly growths on the skin caused by too much sun exposure) on the face or scalp. Imiquimod cream is also used to treat superficial basal cell carcinoma (a type of skin cancer) on the trunk, neck, arms, hands, legs, or feet and warts on the skin of the genital and anal areas. Imiquimod is in a class of medications called immune response modifiers. It treats genital and anal warts by increasing the activity of the body's immune system. It is not known exactly how imiquimod cream works to treat actinic keratoses or superficial basal cell carcinoma. Imiquimod cream does not cure warts, and new warts may appear during treatment. It is not known whether imiquimod cream prevents the spread of warts to other people.
Related Packages: 45802-0368-53Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Imiquimod Topical
Product Information
| NDC | 45802-0368 |
|---|---|
| Product ID | 45802-368_d4dfa9c0-c880-43eb-9c4b-8fa5e7d38395 |
| Associated GPIs | 90773040003720 |
| GCN Sequence Number | 031099 |
| GCN Sequence Number Description | imiquimod CREAM PACK 5 % TOPICAL |
| HIC3 | Z2G |
| HIC3 Description | IMMUNOMODULATORS |
| GCN | 54201 |
| HICL Sequence Number | 012998 |
| HICL Sequence Number Description | IMIQUIMOD |
| Brand/Generic | Generic |
| Proprietary Name | Imiquimod |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Imiquimod |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CREAM |
| Route | TOPICAL |
| Active Ingredient Strength | 12.5 |
| Active Ingredient Units | mg/.25g |
| Substance Name | IMIQUIMOD |
| Labeler Name | Padagis Israel Pharmaceuticals Ltd |
| Pharmaceutical Class | Increased Cytokine Activity [PE], Increased Cytokine Production [PE], Interferon Inducers [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA078837 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 45802-0368-53 (45802036853)
| NDC Package Code | 45802-368-53 |
|---|---|
| Billing NDC | 45802036853 |
| Package | 12 PACKET in 1 CARTON (45802-368-53) / .25 g in 1 PACKET |
| Marketing Start Date | 2012-07-12 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |