Imiquimod NDC 71335-3000

NDC codes

FDA NDC Directory

Product NDC (as listed)71335-3000Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71335-3000Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
71335-3000-1	71335300001	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 Prepack
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078837
Marketing start: Nov 9, 2010
Listing expires: Dec 31, 2026
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

N471335300001 followed by a unit qualifier and the quantity

Package 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 Nov 5, 2025.

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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 078837

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 078837
Product	Strength	Form · route	Labeler	Product NDC
Imiquimod	Imiquimod 12.5 mg/.25g	CreamTopical	DIRECT RX	72189-084
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	Padagis Israel Pharmaceuticals Ltd	45802-368