What is NDC 72189-084?

72189-084 is the product NDC for Imiquimod, Imiquimod 12.5 mg/.25g cream, listed with the FDA by DIRECT RX. It has 1 package NDC, shown above in 10- and 11-digit form.

DIRECT RX, NDC labeler code 72189. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Imiquimod NDC 72189-084 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)72189-084Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72189-0084Add 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
72189-084-24	7218900842472189008424	.25 g in 1 PACKET (72189-084-24)Marketed from Mar 23, 2020

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 — 12.5 mg/.25g
Dosage form: Cream
Route: Topical
Labeler: DIRECT RXNDC labeler code 72189
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078837
Marketing start: Mar 23, 2020
Listing expires: Dec 31, 2026
Other FDA classes: Increased Cytokine Activity (Physiologic effect)Increased Cytokine Production (Physiologic effect)Interferon Inducers (Mechanism)
Identifiers: Product ID 72189-084_2be84443-5bdd-96bd-e063-6294a90a9264SPL ID 2be84443-5bdd-96bd-e063-6294a90a9264SPL set ID a18a3f7e-7254-56c0-e053-2a95a90a7036RxCUI 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

N472189008424 followed by a unit qualifier and the quantity

Package 72189-0084-24. 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 Jan 17, 2025.

Indications (excerpt from the label)

1.1 Actinic Keratosis Imiquimod Cream is indicated for the topical treatment of clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses on the face or scalp in immunocompetent adults. 1.2 Superficial Basal Cell Carcinoma Imiquimod Cream is indicated for the topical treatment of biopsy-confirmed, primary superficial basal cell carcinoma (sBCC) in immunocompetent adults, with a maximum tumor diameter of 2.0 cm, located on the 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. The histological diagnosis of superficial basal cell carcinoma s…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 72189-084

What is NDC 72189-084?: 72189-084 is the product NDC for Imiquimod, Imiquimod 12.5 mg/.25g cream, listed with the FDA by DIRECT RX. 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?: DIRECT RX, NDC labeler code 72189. 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Imiquimod NDCs
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 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	71335-3000	71335-3000-01
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.

FDA NDC Directory listings under ANDA 078837
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	71335-3000
Imiquimod	Imiquimod 12.5 mg/.25g	CreamTopical	Bryant Ranch Prepack	72162-2332