NDC codes

FDA NDC Directory
Product NDC (as listed)68682-272Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68682-0272Add 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
68682-272-7568682027275686820272751 BOTTLE, PUMP in 1 CARTON (68682-272-75) / 7.5 g in 1 BOTTLE, PUMPMarketed from Jun 27, 2018

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 — 37.5 mg/g
Dosage form
Cream
Route
Topical
Labeler
Oceanside PharmacueticalsNDC labeler code 68682
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 022483
Marketing start
Listing expires
Other FDA classes
Increased Cytokine Activity (Physiologic effect)Increased Cytokine Production (Physiologic effect)Interferon Inducers (Mechanism)
Identifiers
Product ID 68682-272_36b25854-8ed2-8f45-e063-6294a90a8b46SPL ID 36b25854-8ed2-8f45-e063-6294a90a8b46SPL set ID d86eeb0e-70e0-4c72-aaa3-37daa1d8611eRxCUI 967017UNII 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

N468682027275 followed by a unit qualifier and the quantity

Package 68682-0272-75. 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 .

Indications (excerpt from the label)

Imiquimod Cream, 3.75% is indicated for the topical treatment of clinically typical, visible, or palpable actinic keratoses (AK) of the face or balding scalp in immunocompetent adults. ( 1.1 ) Imiquimod Cream, 3.75% is indicated for the topical treatment of external genital and perianal warts (EGW) in immunocompetent patients 12 years of age or older. ( 1.2 ) 1.1 Actinic Keratosis Imiquimod Cream, 3.75% is indicated for the topical treatment of clinically typical, visible or palpable actinic keratoses (AK) of the face or balding scalp in immunocompetent adults. 1.2 External Genital Warts Imiquimod Cream, 3.75% is indicated for the topical treatment of external genital and perianal warts (EGW…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68682-272

What is NDC 68682-272?
68682-272 is the product NDC for Imiquimod, Imiquimod 37.5 mg/g cream, listed with the FDA by Oceanside Pharmacueticals. 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?
Oceanside Pharmacueticals, NDC labeler code 68682. 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 50 mg/gCreamTopicalGlenmark Pharmaceuticals Inc., USA68462-53668462-0536-70
ImiquimodImiquimod 50 mg/gCreamTopicalSun Pharmaceutical Industries, Inc.51672-414551672-4145-06
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

Other NDCs under NDA 022483

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

FDA NDC Directory listings under NDA 022483
ProductStrengthForm · routeLabelerProduct NDC
ImiquimodImiquimod 37.5 mg/gCreamTopicalTeva Pharmaceuticals USA, Inc.0093-3133
ZyclaraimiquimodImiquimod 37.5 mg/gCreamTopicalBausch Health US, LLC99207-270
ZyclaraimiquimodImiquimod 37.5 mg/gCreamTopicalBausch Health US, LLC99207-271
ZyclaraimiquimodImiquimod 2.5 mg/gCreamTopicalBausch Health US, LLC99207-276

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