Prescription drug · NDA
Imiquimod NDC 68682-272
Imiquimod 37.5 mg/g · Cream · Topical · Oceanside Pharmacueticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68682-272-75 | 68682027275 | 1 BOTTLE, PUMP in 1 CARTON (68682-272-75) / 7.5 g in 1 BOTTLE, PUMPMarketed from Jun 27, 2018 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Imiquimod
- Generic name (nonproprietary)
- imiquimod
- Active ingredients
- Imiquimod — 37.5 mg/g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Oceanside Pharmacueticals
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022483
- Marketing start
- Listing expires
- Other FDA classes
- Increased Cytokine Activity (Physiologic effect)Increased Cytokine Production (Physiologic effect)Interferon Inducers (Mechanism)
- Identifiers
- Product ID 68682-272_36b25854-8ed2-8f45-e063-6294a90a8b46SPL ID 36b25854-8ed2-8f45-e063-6294a90a8b46SPL set ID d86eeb0e-70e0-4c72-aaa3-37daa1d8611eRxCUI 967017UNII P1QW714R7M
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N468682027275followed by a unit qualifier and the quantityPackage 68682-0272-75. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Imiquimod Cream, 3.75% is indicated for the topical treatment of clinically typical, visible, or palpable actinic keratoses (AK) of the face or balding scalp in immunocompetent adults. ( 1.1 ) Imiquimod Cream, 3.75% is indicated for the topical treatment of external genital and perianal warts (EGW) in immunocompetent patients 12 years of age or older. ( 1.2 ) 1.1 Actinic Keratosis Imiquimod Cream, 3.75% is indicated for the topical treatment of clinically typical, visible or palpable actinic keratoses (AK) of the face or balding scalp in immunocompetent adults. 1.2 External Genital Warts Imiquimod Cream, 3.75% is indicated for the topical treatment of external genital and perianal warts (EGW…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 022483
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Imiquimod | Imiquimod 37.5 mg/g | CreamTopical | Teva Pharmaceuticals USA, Inc. | 0093-3133 |
| Zyclaraimiquimod | Imiquimod 37.5 mg/g | CreamTopical | Bausch Health US, LLC | 99207-270 |
| Zyclaraimiquimod | Imiquimod 37.5 mg/g | CreamTopical | Bausch Health US, LLC | 99207-271 |
| Zyclaraimiquimod | Imiquimod 2.5 mg/g | CreamTopical | Bausch Health US, LLC | 99207-276 |