Over-the-counter drug · OTC MONOGRAPH DRUG
Gembooxt Ketoconazole 1% Medicated Shampoos (Ketoconazole) NDC 76986-025
Ketoconazole .01 g/mL · Liquid · Topical · Guangdong Quadrant Ecological Technology Co., Ltd.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76986-025-01 | 7698600250176986002501 | 300 mL in 1 BOTTLE (76986-025-01)Marketed from Jan 30, 2026 | |
| 76986-025-02 | 7698600250276986002502 | 450 mL in 1 BOTTLE (76986-025-02)Marketed from Jan 30, 2026 | |
| 76986-025-03 | 7698600250376986002503 | 750 mL in 1 BOTTLE (76986-025-03)Marketed from Jan 30, 2026 |
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)
- Gembooxt Ketoconazole 1% Medicated Shampoos
- Generic name (nonproprietary)
- ketoconazole
- Active ingredients
- Ketoconazole — .01 g/mL
- Dosage form
- Liquid
- Route
- Topical
- Labeler
- Guangdong Quadrant Ecological Technology Co., Ltd.NDC labeler code 76986
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication 505G(a)(3)
- Marketing start
- Listing expires
- Other FDA classes
- Azoles (Chemical structure)Cytochrome P450 3A4 Inhibitors (Mechanism)Cytochrome P450 3A5 Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
- Identifiers
- Product ID 76986-025_5a12f0c5-a8de-b428-e063-6294a90a6d75SPL ID 5a12f0c5-a8de-b428-e063-6294a90a6d75SPL set ID 49965e91-43c3-65d7-e063-6294a90abaecRxCUI 240812UNII R9400W927IUPC 6977863764704
- Pharmacologic class
- Azole Antifungal
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
N476986002501followed by a unit qualifier and the quantityPackage 76986-0025-01. 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)
Controls flaking, scaling and itching associated with dandruff
Excerpt only. Read the full label for complete information.
About NDC 76986-025
- What is NDC 76986-025?
- 76986-025 is the product NDC for Gembooxt Ketoconazole 1% Medicated Shampoos, Ketoconazole .01 g/mL liquid, listed with the FDA by Guangdong Quadrant Ecological Technology Co., Ltd.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Gembooxt Ketoconazole 1% Medicated Shampoos (Ketoconazole).
- What is the active ingredient?
- Ketoconazole.
- Who is the labeler?
- Guangdong Quadrant Ecological Technology Co., Ltd., NDC labeler code 76986. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Gembooxt Ketoconazole 1% Medicated Shampoos?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under 505G(a)(3)
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
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