What is NDC 45802-368?

45802-368 is the product NDC for Imiquimod, Imiquimod 12.5 mg/.25g cream, listed with the FDA by Padagis Israel Pharmaceuticals Ltd. It has 2 package NDCs, shown above in 10- and 11-digit form.

Padagis Israel Pharmaceuticals Ltd, NDC labeler code 45802. 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 45802-368 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)45802-368Labeler and product segments. Claims need a package NDC.

Product NDC at billing width45802-0368Add 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
45802-368-53	4580203685345802036853	12 PACKET in 1 CARTON (45802-368-53) / .25 g in 1 PACKETMarketed from Jul 12, 2012
45802-368-62	4580203686245802036862	24 PACKET in 1 CARTON (45802-368-62) / .25 g in 1 PACKETMarketed from Nov 9, 2010

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: Padagis Israel Pharmaceuticals LtdNDC labeler code 45802
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078837
Marketing start: Nov 9, 2010
Listing expires: Dec 31, 2027
Other FDA classes: Increased Cytokine Activity (Physiologic effect)Increased Cytokine Production (Physiologic effect)Interferon Inducers (Mechanism)
Identifiers: Product ID 45802-368_abcace77-08d3-4ee8-8490-4c21e85b722cSPL ID abcace77-08d3-4ee8-8490-4c21e85b722c

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

N445802036853 followed by a unit qualifier and the quantity

Package 45802-0368-53. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 45802-368

What is NDC 45802-368?: 45802-368 is the product NDC for Imiquimod, Imiquimod 12.5 mg/.25g cream, listed with the FDA by Padagis Israel Pharmaceuticals Ltd. It has 2 package NDCs, 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?: Padagis Israel Pharmaceuticals Ltd, NDC labeler code 45802. 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 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	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	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
Imiquimod	Imiquimod 12.5 mg/.25g	CreamTopical	DIRECT RX	72189-084