NDC codes

FDA NDC Directory
Product NDC (as listed)99207-270Labeler and product segments. Claims need a package NDC.
Product NDC at billing width99207-0270Add 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
99207-270-01992070270014 PACKET in 1 CARTON (99207-270-01) / .25 g in 1 PACKETMarketed from Nov 28, 2011

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)
Zyclara
Generic name (nonproprietary)
imiquimod
Active ingredients
Imiquimod — 37.5 mg/g
Dosage form
Cream
Route
Topical
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 99207-270_1216e839-274f-412d-953f-ce56f0cd42a2SPL ID 1216e839-274f-412d-953f-ce56f0cd42a2SPL set ID 28cd9b5b-680b-480f-b33d-9c5b52bbf03dRxCUI 967017, 967021UNII 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

N499207027001 followed by a unit qualifier and the quantity

Package 99207-0270-01. 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)

• ZYCLARA 2.5% and 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 ) • ZYCLARA, 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 ZYCLARA, 2.5% and 3.75% are 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 ZYCLARA, 3.75% is indicated for the topical treatment of external genital and perianal warts (EGW) in immun…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

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, LLC99207-271
ZyclaraimiquimodImiquimod 2.5 mg/gCreamTopicalBausch Health US, LLC99207-276
ImiquimodImiquimod 37.5 mg/gCreamTopicalOceanside Pharmacueticals68682-272

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