Imiquimod
- Product NDC
- 68462-536
- 11-digit product format
- 684620536
- Labeler code
- 68462
- Product ID
- 68462-536_be827b5b-c3e8-4ec3-a8b0-a745e29f8ebc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Imiquimod
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Glenmark Pharmaceuticals Inc., USA
- Application
- ANDA201994
- Marketing category
- ANDA
- Marketing start
- 2012-03-06
- Substance
- IMIQUIMOD
- Active strength
- 50 mg/g
- Pharmacologic classes
- Increased Cytokine Activity [PE], Increased Cytokine Production [PE], Interferon Inducers [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Imiquimod
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| IMIQUIMOD | 50 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | P1QW714R7M |
| Rxcui | 310982 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68462-536-01 | Imiquimod | 0.25 g in 1 PACKET | CREAM | 0.25 | | 12 |
| 68462-536-70 | Imiquimod | 24 in 1 CARTON | CREAM | 24 | | 12 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| IMIQUIMOD | ACTIVE INGREDIENT | P1QW714R7M | IMIQUIMOD CREAM [GLENMARK PHARMACEUTICALS INC., USA] | 5 | |
| IMIQUIMOD | ACTIVE MOIETY | P1QW714R7M | IMIQUIMOD CREAM [GLENMARK PHARMACEUTICALS INC., USA] | 5 | |
| BENZYL ALCOHOL | INACTIVE INGREDIENT | LKG8494WBH | IMIQUIMOD CREAM [GLENMARK PHARMACEUTICALS INC., USA] | 5 | |
| CETYL ALCOHOL | INACTIVE INGREDIENT | 936JST6JCN | IMIQUIMOD CREAM [GLENMARK PHARMACEUTICALS INC., USA] | 5 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | IMIQUIMOD CREAM [GLENMARK PHARMACEUTICALS INC., USA] | 5 | |
| ISOSTEARIC ACID | INACTIVE INGREDIENT | X33R8U0062 | IMIQUIMOD CREAM [GLENMARK PHARMACEUTICALS INC., USA] | 5 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | IMIQUIMOD CREAM [GLENMARK PHARMACEUTICALS INC., USA] | 5 | |
| PETROLATUM | INACTIVE INGREDIENT | 4T6H12BN9U | IMIQUIMOD CREAM [GLENMARK PHARMACEUTICALS INC., USA] | 5 | |
| POLYSORBATE 60 | INACTIVE INGREDIENT | CAL22UVI4M | IMIQUIMOD CREAM [GLENMARK PHARMACEUTICALS INC., USA] | 5 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | IMIQUIMOD CREAM [GLENMARK PHARMACEUTICALS INC., USA] | 5 | |
| SORBITAN MONOSTEARATE | INACTIVE INGREDIENT | NVZ4I0H58X | IMIQUIMOD CREAM [GLENMARK PHARMACEUTICALS INC., USA] | 5 | |
| STEARYL ALCOHOL | INACTIVE INGREDIENT | 2KR89I4H1Y | IMIQUIMOD CREAM [GLENMARK PHARMACEUTICALS INC., USA] | 5 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | IMIQUIMOD CREAM [GLENMARK PHARMACEUTICALS INC., USA] | 5 | |
| XANTHAN GUM | INACTIVE INGREDIENT | TTV12P4NEE | IMIQUIMOD CREAM [GLENMARK PHARMACEUTICALS INC., USA] | 5 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68462-536 | IMIQUIMOD CREAM [GLENMARK PHARMACEUTICALS INC., USA] | 11 | Current NDC, Legacy NDC, 2 package rows | 20240104_663e39a9-a29e-473f-89ec-4c7c6bc27b8a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68462-536-01 | 68462053601 | 0.25 g in 1 PACKET | 0.25 g | | | | | Historical |
| 68462-536-70 | 68462053670 | 24 PACKET in 1 CARTON (68462-536-70) / .25 g in 1 PACKET (68462-536-01) | 24 packet | 2012-03-06 | 0000-00-00 | No | No | Current |