Over-the-counter drug · ANDA
Diclofenac Sodium (Diclofenac sodium topical gel, 1%) NDC 63868-730
Diclofenac sodium 10 mg/g · Gel · Topical · Chain Drug Marketing Association INC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63868-730-01 | 6386807300163868073001 | 1 TUBE in 1 CARTON (63868-730-01) / 100 g in 1 TUBEMarketed from Sep 26, 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)
- Diclofenac Sodium
- Generic name (nonproprietary)
- diclofenac sodium topical gel, 1%
- Active ingredients
- Diclofenac sodium — 10 mg/g
- Dosage form
- Gel
- Route
- Topical
- Labeler
- Chain Drug Marketing Association INCNDC labeler code 63868
- 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 63868-730_860cabb0-eb63-5e45-bb3e-78bfc550fa83SPL ID 860cabb0-eb63-5e45-bb3e-78bfc550fa83SPL set ID 625d21e8-0731-1157-30fe-9f9868ff8dc4RxCUI 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
N463868073001followed by a unit qualifier and the quantityPackage 63868-0730-01. 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 63868-730
- What is NDC 63868-730?
- 63868-730 is the product NDC for Diclofenac Sodium, Diclofenac sodium 10 mg/g gel, listed with the FDA by Chain Drug Marketing Association INC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Diclofenac Sodium (Diclofenac Sodium topical gel, 1%).
- What is the active ingredient?
- Diclofenac sodium.
- Who is the labeler?
- Chain Drug Marketing Association INC, NDC labeler code 63868. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Diclofenac Sodium?
- 241 other product NDCs are listed under this name. See all Diclofenac Sodium NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Diclofenac Sodium products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Diclofenac Sodiumdiclofenac sodium topical gel, 1% | Diclofenac sodium 10 mg/g | GelTopical | IPG Pharmaceuticals, inc. | 71085-084 | 71085-0084-03 |
| Diclofenac Sodium | Diclofenac sodium 10 mg/g | GelTopical | Target Corporation | 11673-028 | 11673-0028-1011673-0028-15 |
| Diclofenac Sodium | Diclofenac sodium 75 mg/1 | Tablet, Delayed releaseOral | Northwind Health Company, LLC | 82868-114 | 82868-0114-30 |
| Diclofenac Sodium | Diclofenac sodium 10 mg/g | GelTopical | Preferred Pharmaceuticals Inc. | 68788-4135 | 68788-4135-01 |
| Diclofenac Sodium | Diclofenac sodium 100 mg/1 | Tablet, Film coated, Extended releaseOral | Aurobindo Pharma Limited | 84386-103 | 84386-0103-01 |
| Diclofenac Sodium | Diclofenac sodium 50 mg/1 | Tablet, Delayed releaseOral | REMEDYREPACK INC. | 70518-4694 | 70518-4694-00 |
| Diclofenac sodium | Diclofenac sodium 30 mg/g | GelTopical | Preferred Pharmaceuticals Inc. | 68788-4118 | 68788-4118-01 |
| Diclofenac Sodium | Diclofenac sodium 10 mg/g | GelTopical | Preferred Pharmaceuticals Inc. | 68788-4335 | 68788-4335-01 |
| Diclofenac Sodium | Diclofenac sodium 25 mg/1 | Tablet, Delayed releaseOral | Umedica Laboratories USA Inc. | 60290-082 | 60290-0082-01 |
| Diclofenac Sodium | Diclofenac sodium 50 mg/1 | Tablet, Delayed releaseOral | Umedica Laboratories USA Inc. | 60290-083 | 60290-0083-0160290-0083-0260290-0083-03+1 more |
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 | 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 |
| Arthritis Paindiclofenac sodium topical gel, 1% | Diclofenac sodium 10 mg/g | GelTopical | Discount Drug Mart, Inc. | 53943-523 |
| 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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