Over-the-counter drug · ANDA
Salonpas (Diclofenac sodium) NDC 55328-801
Diclofenac sodium 10 mg/g · Gel · Topical · Hisamitsu America, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55328-801-10 | 5532808011055328080110 | 1 TUBE in 1 CARTON (55328-801-10) / 100 g in 1 TUBEMarketed from Mar 21, 2016 |
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)
- Salonpas
- Generic name (nonproprietary)
- diclofenac sodium
- Active ingredients
- Diclofenac sodium — 10 mg/g
- Dosage form
- Gel
- Route
- Topical
- Labeler
- Hisamitsu America, Inc.NDC labeler code 55328
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208077
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)
- Identifiers
- Product ID 55328-801_f4f1cff3-d484-46cc-ac7a-639874afd71aSPL ID f4f1cff3-d484-46cc-ac7a-639874afd71aSPL set ID f439445d-046e-4220-a4a7-13d750ee0949RxCUI 855633UNII QTG126297Q
- Pharmacologic class
- Nonsteroidal Anti-inflammatory Drug
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
N455328080110followed by a unit qualifier and the quantityPackage 55328-0801-10. 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)
Use(s) for the temporary relief of arthritis pain ONLY in the following areas head, wrist, elbow (upper body areas) foot, ankle, knee (lower body areas) this product may take up to 7 days to work for arthritis pain; it is not for immediate relief. If no pain relief in 7 days, stop use.
Excerpt only. Read the full label for complete information.
About NDC 55328-801
- What is NDC 55328-801?
- 55328-801 is the product NDC for Salonpas (diclofenac sodium), Diclofenac sodium 10 mg/g gel, listed with the FDA by Hisamitsu America, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Salonpas (Diclofenac Sodium).
- What is the active ingredient?
- Diclofenac sodium.
- Who is the labeler?
- Hisamitsu America, Inc., NDC labeler code 55328. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Salonpas?
- 2 other product NDCs are listed under this name. See all Salonpas NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Salonpas products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Salonpascamphor, menthol, methyl salicylate | Camphor (Synthetic) 86.24 mg/1 + 2 more ingredients | PatchPercutaneous, Topical, Transdermal | Hisamitsu Pharmaceutical Co., Inc. | 46581-210 | 46581-0210-06 |
| Salonpascamphor, menthol, methyl salicylate | Camphor (Synthetic) 21.56 mg/1 + 2 more ingredients | PatchPercutaneous, Topical, Transdermal | Hisamitsu Pharmaceutical Co., Inc. | 46581-110 | 46581-0110-1446581-0110-2046581-0110-60+1 more |
Other NDCs under ANDA 208077
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 |
|---|---|---|---|---|
| Diclofenac sodiumdiclofenac | Diclofenac sodium 10 mg/g | GelTopical | Amneal Pharmaceuticals NY LLC | 69238-2053 |
| Arthritis Pain Relieverdiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | P & L Development, LLC | 59726-012 |
| Arthritis Pain Relieverdiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | AmerisourceBergen (Good Neighbor Pharmacy) 46122 | 46122-752 |
| Diclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | Sportpharm LLC | 85766-136 |
| Arthritis Pain Relieverdiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | CVS PHARMACY, INC | 51316-073 |
| Diclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | Best Choice (Valu Merchandisers Company) | 63941-812 |
| Diclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | Safeway, Inc. | 21130-028 |
| Arthritis Pain Relieverdiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | QUALITY CHOICE (Chain Drug Marketing Association) | 83324-306 |
| Arthritis Pain Relieverdiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | CVS PHARMACY, INC | 51316-012 |
| Diclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | Walgreens | 0363-1210 |
| Arthritis Pain Relieverdiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | Chain Drug Consortium, LLC | 68016-171 |
| Diclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | Costco Wholesale | 63981-211 |
| Diclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | CARDINAL HEALTH 110, LLC. DBA LEADER 70000 | 70000-0555 |
| Diclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | Rugby Laboratories | 0536-1294 |
| Diclofenac sodiumdiclofenac | Diclofenac sodium 10 mg/g | GelTopical | Scholl's Wellness Company | 73469-2053 |
| Arthritis Pain Relieverdiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | Family Dollar (FAMILY WELLNESS) | 55319-969 |
| Diclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | CVS Pharmacy | 69842-974 |
| Diclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | 49035-269 |