Prescription drug · NDA
Zyclara (Imiquimod) NDC 99207-276
Imiquimod 2.5 mg/g · Cream · Topical · Bausch Health US, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 99207-276-01 | 9920702760199207027601 | 1 BOTTLE, PUMP in 1 CARTON (99207-276-01) / 7.5 g in 1 BOTTLE, PUMPMarketed from Feb 29, 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)
- Zyclara
- Generic name (nonproprietary)
- imiquimod
- Active ingredients
- Imiquimod — 2.5 mg/g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Bausch Health US, LLCNDC labeler code 99207
- 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 99207-276_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
N499207027601followed by a unit qualifier and the quantityPackage 99207-0276-01. 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.
About NDC 99207-276
- What is NDC 99207-276?
- 99207-276 is the product NDC for Zyclara (imiquimod), Imiquimod 2.5 mg/g cream, listed with the FDA by Bausch Health US, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Zyclara (Imiquimod).
- What is the active ingredient?
- Imiquimod.
- Who is the labeler?
- Bausch Health US, LLC, NDC labeler code 99207. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Zyclara?
- 2 other product NDCs are listed under this name. See all Zyclara NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Zyclara products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Zyclaraimiquimod | Imiquimod 37.5 mg/g | CreamTopical | Bausch Health US, LLC | 99207-271 | 99207-0271-0199207-0271-75 |
| Zyclaraimiquimod | Imiquimod 37.5 mg/g | CreamTopical | Bausch Health US, LLC | 99207-270 | 99207-0270-01 |
Other NDCs under NDA 022483
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Imiquimod | Imiquimod 37.5 mg/g | CreamTopical | Teva Pharmaceuticals USA, Inc. | 0093-3133 |
| Imiquimod | Imiquimod 37.5 mg/g | CreamTopical | Oceanside Pharmacueticals | 68682-272 |
| Zyclaraimiquimod | Imiquimod 37.5 mg/g | CreamTopical | Bausch Health US, LLC | 99207-270 |
| Zyclaraimiquimod | Imiquimod 37.5 mg/g | CreamTopical | Bausch Health US, LLC | 99207-271 |