Over-the-counter drug · OTC MONOGRAPH DRUG
Premier Value Antifungal Maximum Strength (Undecylenic acid) NDC 68016-474
Undecylenic acid 25 mg/30mL · Liquid · Topical · PHARMACY VALUE ALLIANCE, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68016-474-00 | 6801604740068016047400 | 30 mL in 1 BOTTLE, WITH APPLICATOR (68016-474-00)Marketed from Apr 10, 2019 |
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)
- Premier Value Antifungal Maximum StrengthSuffix: Maximum Strength
- Generic name (nonproprietary)
- undecylenic acid
- Active ingredients
- Undecylenic acid — 25 mg/30mL
- Dosage form
- Liquid
- Route
- Topical
- Labeler
- PHARMACY VALUE ALLIANCE, LLCNDC labeler code 68016
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 005
- Marketing start
- Listing expires
- Identifiers
- Product ID 68016-474_49f1dae5-2b13-47e8-9a1a-cf6cbf834400SPL ID 49f1dae5-2b13-47e8-9a1a-cf6cbf834400SPL set ID f5694ee5-616c-40f6-8da4-c3620dbcd6f7UNII 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
N468016047400followed by a unit qualifier and the quantityPackage 68016-0474-00. 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)
Uses ▪ For the cure of most: ▪ ringworm (tinea corporis) ▪ athlete’s foot (tinea pedis) ▪ itching ▪ scaling ▪ cracking ▪ burning ▪ redness ▪ soreness ▪ irritation ▪ discomfort which may accompany these conditions.
Excerpt only. Read the full label for complete information.
About NDC 68016-474
- What is NDC 68016-474?
- 68016-474 is the product NDC for Premier Value Antifungal Maximum Strength, Undecylenic acid 25 mg/30mL liquid, listed with the FDA by PHARMACY VALUE ALLIANCE, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Premier Value Antifungal Maximum Strength (Undecylenic Acid).
- What is the active ingredient?
- Undecylenic acid.
- Who is the labeler?
- PHARMACY VALUE ALLIANCE, LLC, NDC labeler code 68016. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Premier Value Antifungal Maximum Strength?
- 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.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Terrasil Tinea Treatment MAXclotrimazole | Clotrimazole 1 g/100g | OintmentTopical | Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions | 24909-104 |
| Everywhere Flushable Wipes | Benzalkonium chloride .15 U/100U | ClothTopical | Shenzhen Shierjie Biological Engineering Co., LTD | 43116-042 |
| Seacall Hydrocortisone Ointment.seacall hydrocortisone ointment | Hydrocortisone .1 g/100g | OintmentTopical | Guangdong Quadrant Ecological Technology Co., Ltd. | 76986-006 |
| Fungal Nail Nighttime Renewal Patchestolnaftate 1% | Tolnaftate 1 g/1001 | PatchTopical | 100 KARMA INC | 85569-009 |
| Oiangna Tea Tree Oil Antifungalclotrimazole 1% | Clotrimazole 1 g/116g | SoapTopical | Guangzhou Huixue Biotechnology Co., Ltd. | 87204-285 |
| Eyelid Wipes | 4-terpineol .003 U/100U; Melaleuca alternifolia (Tea tree) leaf oil .04 U/100U | ClothTopical | Shenzhen Shierjie Biological Engineering Co., LTD | 43116-040 |
| CAREALL Clotrimazoleclotrimazole | Clotrimazole 10 g/g | CreamTopical | New World Imports, Inc | 51824-063 |
| Clotrimazole | Clotrimazole 1 g/100g | CreamTopical | Cardinal Health 110 dba LEADER | 70000-0667 |
| Gemachlich ZuHause Fungal Nail Revitalizer | Undecylenic acid 11 g/100mL | LiquidTopical | Guangdong Quadrant Ecological Technology Co., Ltd. | 76986-007 |
| Treatonic Toenail Fungus Treatment Kittoenail fungus treatment | — | KitTopical | 100 KARMA INC | 85569-010 |
| Fungal Nail Treatmentglacial acetic acid | Acetic acid 10.5 g/100mL | LiquidTopical | Guchutang Biotechnology (Longyan) Co., Ltd | 87083-020 |
| 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 |
| Clotrimazole | Clotrimazole 1 g/100g | CreamTopical | A-S Medication Solutions | 50090-6546 |
| 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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