Over-the-counter drug · OTC MONOGRAPH DRUG
Hongocura S (Undecylenic acid) NDC 53145-319
Undecylenic acid 20 mg/100mL · Spray · Topical · MENPER DISTRIBUTORS, INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 53145-319-02 | 5314503190253145031902 | 1 BOTTLE, SPRAY in 1 CARTON (53145-319-02) / 30 mL in 1 BOTTLE, SPRAYMarketed from Apr 6, 2020 |
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)
- Hongocura SSuffix: S
- Generic name (nonproprietary)
- undecylenic acid
- Active ingredients
- Undecylenic acid — 20 mg/100mL
- Dosage form
- Spray
- Route
- Topical
- Labeler
- MENPER DISTRIBUTORS, INC.NDC labeler code 53145
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 005
- Marketing start
- Listing expires
- Identifiers
- Product ID 53145-319_3a8adc39-90f5-6dba-e063-6394a90ae227SPL ID 3a8adc39-90f5-6dba-e063-6394a90ae227SPL set ID 4a21f371-bfc1-4e66-af16-55b3283872b7UNII K3D86KJ24N
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
N453145031902followed by a unit qualifier and the quantityPackage 53145-0319-02. 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)
Do not use on children Under 2 years of age, unless directed by a doctor for diaper rash Stop use and ask a doctor if Irritation occurs there is no improvement within 4 weeks When using this product Avoid contact with eyes and mucus membrane
Excerpt only. Read the full label for complete information.
About NDC 53145-319
- What is NDC 53145-319?
- 53145-319 is the product NDC for Hongocura S (undecylenic acid), Undecylenic acid 20 mg/100mL spray, listed with the FDA by MENPER DISTRIBUTORS, INC.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Hongocura S (Undecylenic Acid).
- What is the active ingredient?
- Undecylenic acid.
- Who is the labeler?
- MENPER DISTRIBUTORS, INC., NDC labeler code 53145. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Hongocura S?
- 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 M 005
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
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| Treatonic Toenail Fungus Treatment Kittoenail fungus treatment | — | KitTopical | 100 KARMA INC | 85569-010 |
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| Good Neighbor Pharmacy Clotrimazoleclotrimazole | Clotrimazole 10 mg/g | CreamTopical | AmerisourceBergen | 24385-205 |
| Terrasil Ringworm Treatment MAXclotrimazole | Clotrimazole 1 g/100g | OintmentTopical | Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions | 24909-102 |
| Clotrimazolefamily wellness clotrimazole | Clotrimazole 1 g/100g | CreamTopical | Trifecta Pharmaceuticals USA LLC | 69396-038 |
| Paume Moisturizing Antibacterial Hand Gelalcohol | Alcohol 69 mL/100mL | GelTopical | Paume Inc | 80328-123 |
| Viachs ANTIFUNGAL Creammiconazole nitrate 2% antifungal cream | Miconazole nitrate 2 g/100g | CreamTopical | Wenzhou Yuyuan Pharmaceutical Co., Ltd. | 87786-044 |
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| RoyceDerm ANTIFUNGAL .soap.clotrimazole 1% | Clotrimazole 2.26 g/226g | SoapTopical | RoyceDerm LLC | 85424-019 |
| 1% ketoconazole anti dandruff1% ketoconazole anti dandruff shampoo | Ketoconazole 1 g/100mL | ShampooCutaneous | Fast Sold LLC | 86241-110 |
| Charmpoo ANTIFUNGAL BODY Creammiconazole nitrate 2% antifungal body cream | Miconazole nitrate 2 g/100g | CreamTopical | Wenzhou Yuyuan Pharmaceutical Co., Ltd. | 87786-042 |
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