What is NDC 68462-536?

68462-536 is the product NDC for Imiquimod, Imiquimod 50 mg/g cream, listed with the FDA by Glenmark Pharmaceuticals Inc., USA. It has 1 package NDC, shown above in 10- and 11-digit form.

Glenmark Pharmaceuticals Inc., USA, NDC labeler code 68462. 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 68462-536 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68462-536Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68462-0536Add 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
68462-536-70	6846205367068462053670	24 PACKET in 1 CARTON (68462-536-70) / .25 g in 1 PACKET (68462-536-01)Marketed from Mar 6, 2012

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 — 50 mg/g
Dosage form: Cream
Route: Topical
Labeler: Glenmark Pharmaceuticals Inc., USANDC labeler code 68462
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 201994
Marketing start: Mar 6, 2012
Listing expires: Dec 31, 2027
Other FDA classes: Increased Cytokine Activity (Physiologic effect)Increased Cytokine Production (Physiologic effect)Interferon Inducers (Mechanism)
Identifiers: Product ID 68462-536_be827b5b-c3e8-4ec3-a8b0-a745e29f8ebcSPL ID be827b5b-c3e8-4ec3-a8b0-a745e29f8ebcSPL set ID 663e39a9-a29e-473f-89ec-4c7c6bc27b8aRxCUI 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

N468462053670 followed by a unit qualifier and the quantity

Package 68462-0536-70. 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 23, 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)

About NDC 68462-536

What is NDC 68462-536?: 68462-536 is the product NDC for Imiquimod, Imiquimod 50 mg/g cream, listed with the FDA by Glenmark Pharmaceuticals Inc., USA. 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?: Glenmark Pharmaceuticals Inc., USA, NDC labeler code 68462. 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	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