Prescription drug · ANDA
Imiquimod NDC 71335-3000
Imiquimod 12.5 mg/.25g · Cream · Topical · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-3000-1 | 7133530000171335300001 | 24 PACKET in 1 CARTON (71335-3000-1) / .25 g in 1 PACKETMarketed from Nov 5, 2025 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 12.5 mg/.25g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Bryant Ranch PrepackNDC labeler code 71335
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078837
- Marketing start
- Listing expires
- Other FDA classes
- Increased Cytokine Activity (Physiologic effect)Increased Cytokine Production (Physiologic effect)Interferon Inducers (Mechanism)
- Identifiers
- Product ID 71335-3000_c37787b9-97c9-4b70-8fa7-847cebc2f0e4SPL ID c37787b9-97c9-4b70-8fa7-847cebc2f0e4SPL set ID 9291e5cd-b83d-4b43-88f5-30cac6cef5ffRxCUI 310982UNII 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
N471335300001followed by a unit qualifier and the quantityPackage 71335-3000-01. 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 is indicated for the topical treatment of: • Clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses (AK) on the face or scalp in immunocompetent adults. ( 1.1 ) • Biopsy-confirmed, primary superficial basal cell carcinoma (sBCC) in immunocompetent adults with a maximum tumor diameter of 2.0 cm on trunk (excluding anogenital skin), neck, or extremities (excluding hands and feet), only when surgical methods are medically less appropriate and patient follow-up can be reasonably assured. ( 1.2 ) • External genital and perianal warts (EGW) in immunocompetent patients 12 years of age and older. ( 1.3 ) 1.1 Actinic Keratosis Imiquimod Cream is indicated for the top…
Excerpt only. Read the full label for complete information.
About NDC 71335-3000
- What is NDC 71335-3000?
- 71335-3000 is the product NDC for Imiquimod, Imiquimod 12.5 mg/.25g cream, listed with the FDA by Bryant Ranch Prepack. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Imiquimod.
- What is the active ingredient?
- Imiquimod.
- Who is the labeler?
- Bryant Ranch Prepack, NDC labeler code 71335. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Imiquimod?
- 10 other product NDCs are listed under this name. See all Imiquimod NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Imiquimod products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Imiquimod | Imiquimod 37.5 mg/g | CreamTopical | Anvi Pharmaceuticals Inc. | 87519-004 | 87519-0004-75 |
| Imiquimod | Imiquimod 37.5 mg/g | CreamTopical | Sun Pharmaceutical Industries, Inc. | 51672-4174 | 51672-4174-0651672-4174-09 |
| Imiquimod | Imiquimod 37.5 mg/g | CreamTopical | Teva Pharmaceuticals USA, Inc. | 0093-3133 | 00093-3133-31 |
| Imiquimod | Imiquimod 12.5 mg/.25g | CreamTopical | DIRECT RX | 72189-084 | 72189-0084-24 |
| Imiquimod | Imiquimod 37.5 mg/g | CreamTopical | Oceanside Pharmacueticals | 68682-272 | 68682-0272-75 |
| Imiquimod | Imiquimod 50 mg/g | CreamTopical | Glenmark Pharmaceuticals Inc., USA | 68462-536 | 68462-0536-70 |
| Imiquimod | Imiquimod 50 mg/g | CreamTopical | Sun Pharmaceutical Industries, Inc. | 51672-4145 | 51672-4145-06 |
| Imiquimod | Imiquimod 12.5 mg/.25g | CreamTopical | Padagis Israel Pharmaceuticals Ltd | 45802-368 | 45802-0368-5345802-0368-62 |
| Imiquimod | Imiquimod 12.5 mg/.25g | CreamTopical | Bryant Ranch Prepack | 71335-2725 | 71335-2725-01 |
| Imiquimod | Imiquimod 12.5 mg/.25g | CreamTopical | Bryant Ranch Prepack | 72162-2332 | 72162-2332-02 |
Other NDCs under ANDA 078837
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 12.5 mg/.25g | CreamTopical | Padagis Israel Pharmaceuticals Ltd | 45802-368 |
| Imiquimod | Imiquimod 12.5 mg/.25g | CreamTopical | Bryant Ranch Prepack | 71335-2725 |
| Imiquimod | Imiquimod 12.5 mg/.25g | CreamTopical | Bryant Ranch Prepack | 72162-2332 |
| Imiquimod | Imiquimod 12.5 mg/.25g | CreamTopical | DIRECT RX | 72189-084 |