NDC codes

FDA NDC Directory
Product NDC (as listed)51672-4145Labeler and product segments. Claims need a package NDC.
Product NDC at billing width51672-4145Add 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 NDC11-digit (billing)PackageCopy
51672-4145-6516724145065167241450624 PACKET in 1 CARTON (51672-4145-6) / .25 g in 1 PACKET (51672-4145-8)Marketed from Apr 15, 2011

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 — 50 mg/g
Dosage form
Cream
Route
Topical
Labeler
Sun Pharmaceutical Industries, Inc.NDC labeler code 51672
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 200173
Marketing start
Listing expires
Other FDA classes
Increased Cytokine Activity (Physiologic effect)Increased Cytokine Production (Physiologic effect)Interferon Inducers (Mechanism)
Identifiers
Product ID 51672-4145_3c178924-2055-ce8d-e063-6294a90a644fSPL ID 3c178924-2055-ce8d-e063-6294a90a644fSPL set ID 59af8153-4cf8-4f22-9000-f239798d52d1RxCUI 310982UNII P1QW714R7MUPC 0351672414566

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

N451672414506 followed by a unit qualifier and the quantity

Package 51672-4145-06. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

Imiquimod Cream USP, 5% 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; maximum tumor diameter of 2.0 cm on trunk, 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/condyloma acuminata in patients 12 years old or older ( 1.3 ). Limitations of Use: Efficacy was not demonstrated for molluscum contagiosum in children aged 2-12 ( …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 51672-4145

What is NDC 51672-4145?
51672-4145 is the product NDC for Imiquimod, Imiquimod 50 mg/g cream, listed with the FDA by Sun Pharmaceutical Industries, Inc.. 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?
Sun Pharmaceutical Industries, Inc., NDC labeler code 51672. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
ImiquimodImiquimod 37.5 mg/gCreamTopicalAnvi Pharmaceuticals Inc.87519-00487519-0004-75
ImiquimodImiquimod 37.5 mg/gCreamTopicalSun Pharmaceutical Industries, Inc.51672-417451672-4174-0651672-4174-09
ImiquimodImiquimod 37.5 mg/gCreamTopicalTeva Pharmaceuticals USA, Inc.0093-313300093-3133-31
ImiquimodImiquimod 12.5 mg/.25gCreamTopicalDIRECT RX72189-08472189-0084-24
ImiquimodImiquimod 37.5 mg/gCreamTopicalOceanside Pharmacueticals68682-27268682-0272-75
ImiquimodImiquimod 50 mg/gCreamTopicalGlenmark Pharmaceuticals Inc., USA68462-53668462-0536-70
ImiquimodImiquimod 12.5 mg/.25gCreamTopicalPadagis Israel Pharmaceuticals Ltd45802-36845802-0368-5345802-0368-62
ImiquimodImiquimod 12.5 mg/.25gCreamTopicalBryant Ranch Prepack71335-272571335-2725-01
ImiquimodImiquimod 12.5 mg/.25gCreamTopicalBryant Ranch Prepack71335-300071335-3000-01
ImiquimodImiquimod 12.5 mg/.25gCreamTopicalBryant Ranch Prepack72162-233272162-2332-02

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