Over-the-counter drug · ANDA
Arthritis Pain (Diclofenac sodium topical gel, 1%) NDC 53943-523
Diclofenac sodium 10 mg/g · Gel · Topical · Discount Drug Mart, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 53943-523-01 | 5394305230153943052301 | 1 TUBE in 1 CARTON (53943-523-01) / 100 g in 1 TUBEMarketed from Sep 1, 2024 |
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)
- Arthritis Pain
- Generic name (nonproprietary)
- diclofenac sodium topical gel, 1%
- Active ingredients
- Diclofenac sodium — 10 mg/g
- Dosage form
- Gel
- Route
- Topical
- Labeler
- Discount Drug Mart, Inc.NDC labeler code 53943
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210986
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)
- Identifiers
- Product ID 53943-523_9304a874-8711-b556-d4bf-8babc87fde6cSPL ID 9304a874-8711-b556-d4bf-8babc87fde6cSPL set ID ae1ebe9c-b1fa-6762-949e-cb83b33319a2RxCUI 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
N453943052301followed by a unit qualifier and the quantityPackage 53943-0523-01. 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)
Uses for the temporary relief of arthritis pain ONLY in the following areas: hand, 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 53943-523
- What is NDC 53943-523?
- 53943-523 is the product NDC for Arthritis Pain, Diclofenac sodium 10 mg/g gel, listed with the FDA by Discount Drug Mart, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Arthritis Pain (Diclofenac sodium topical gel, 1%).
- What is the active ingredient?
- Diclofenac sodium.
- Who is the labeler?
- Discount Drug Mart, Inc., NDC labeler code 53943. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Arthritis Pain?
- 8 other product NDCs are listed under this name. See all Arthritis Pain NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Arthritis Pain products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Arthritis Painacetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | Grocery Outlet, Inc. | 85828-200 | 85828-0200-01 |
| Arthritis Painacetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | AMERIFOODS TRADING COMPANY | 61504-200 | 61504-0200-03 |
| Arthritis Painacetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | HYVEE INC | 42507-205 | 42507-0205-0142507-0205-0242507-0205-03+2 more |
| Arthritis Painacetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | AAA Pharmaceutical, Inc. | 57344-200 | 57344-0200-02 |
| Arthritis Painacetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | SAM'S WEST INC | 68196-034 | 68196-0034-02 |
| Arthritis Painacetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | BETTER LIVING BRANDS, LLC | 21130-097 | 21130-0097-0121130-0097-05 |
| Arthritis Paindiclofenac sodium topical gel, 1% | Diclofenac sodium 10 mg/g | GelTopical | Strategic Sourcing Services, LLC | 70677-1125 | 70677-1125-01 |
| Arthritis Painacetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | DISCOUNT DRUG MART | 53943-200 | 53943-0200-0253943-0200-0353943-0200-09 |
Other NDCs under ANDA 210986
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 |
|---|---|---|---|---|
| Arthritis Paindiclofenac sodium topical gel, 1% | Diclofenac sodium 10 mg/g | GelTopical | Strategic Sourcing Services, LLC | 70677-1125 |
| Diclofenac Sodiumdiclofenac sodium 1% | Diclofenac sodium 10 mg/g | GelTopical | SOLA Pharmaceuticals | 70512-106 |
| Diclofenac Sodiumdiclofenac sodium topical gel, 1% | Diclofenac sodium 10 mg/g | GelTopical | BluePoint Laboratories | 68001-621 |
| Diclofenac Sodium Gel | Diclofenac sodium 10 mg/g | GelTopical | Direct_Rx | 72189-479 |
| Diclofenac Sodiumdiclofenac sodium topical gel, 1% | Diclofenac sodium 10 mg/g | GelTopical | NuCare Pharmaceuticals,Inc. | 68071-3483 |
| Curist Arthritis Reliefdiclofenac sodium | Diclofenac sodium 1 g/100g | GelTopical | Little Pharma, Inc. | 72559-020 |
| Diclofenac Sodiumdiclofenac sodium topical gel, 1% | Diclofenac sodium 10 mg/g | GelTopical | Proficient Rx LP | 71205-747 |
| Diclofenac Sodiumdiclofenac sodium topical gel, 1% | Diclofenac sodium 10 mg/g | GelTopical | Chain Drug Marketing Association INC | 63868-730 |
| Diclofenac Sodiumdiclofenac sodium topical gel, 1%, | Diclofenac sodium 10 mg/g | GelTopical | A-S Medication Solutions | 50090-6998 |
| Diclofenac Sodiumdiclofenac sodium topical gel, 1% | Diclofenac sodium 10 mg/g | GelTopical | GERI-CARE PHARMACEUTICALS CORP | 57896-140 |
| Diclofenac Sodiumdiclofenac sodium topical gel, 1% | Diclofenac sodium 10 mg/g | GelTopical | Dr. Reddy's Laboratories Inc. | 43598-885 |
| Diclofenac Sodiumdiclofenac sodium topical gel, 1%, | Diclofenac sodium 10 mg/g | GelTopical | Asclemed USA, Inc. | 76420-091 |
| Diclofenac Sodium Topical Gel 1%diclofenac sodium topical gel, 1% | Diclofenac sodium 10 mg/g | GelTopical | Walgreens Company | 0363-7065 |
| Aspercreme Arthritisdiclofenac sodium | Diclofenac sodium .01 g/g | GelTopical | Chattem, Inc. | 41167-0571 |
| Diclofenac Sodiumdiclofenac sodium topical gel, 1% | Diclofenac sodium 10 mg/g | GelTopical | Simple Diagnostics | 62379-401 |
| Diclofenac Sodiumdiclofenac sodium topical gel, 1% | Diclofenac sodium 10 mg/g | GelTopical | Sportpharm LLC | 85766-160 |
| Diclofenac Sodiumdiclofenac sodium topical gel, 1% | Diclofenac sodium 10 mg/g | GelTopical | IPG Pharmaceuticals, inc. | 71085-084 |
| Diclofenac Sodiumdiclofenac sodium topical gel, 1% | Diclofenac sodium 10 mg/g | GelTopical | Dr. Reddy's Laboratories Inc. | 43598-977 |
| Diclofenac Sodiumdiclofenac sodium topical gel, 1%, | Diclofenac sodium 10 mg/g | GelTopical | Proficient Rx LP | 71205-552 |
| Diclofenac Sodium Topical Gel 1%diclofenac sodium topical gel, 1% | Diclofenac sodium 10 mg/g | GelTopical | Kroger Company | 30142-025 |
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