Over-the-counter drug · ANDA
Diclofenac Sodium Topical Gel 1% NDC 0363-7065
diclofenac sodium topical gel, 1% · Diclofenac sodium 10 mg/g · Gel · Topical · Walgreens Company
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0363-7065-10 | 00363706510 | 1 TUBE in 1 CARTON (0363-7065-10) / 100 g in 1 TUBEMarketed from Sep 14, 2020 | |
| 0363-7065-15 | 00363706515 | 1 TUBE in 1 CARTON (0363-7065-15) / 150 g in 1 TUBEMarketed from Jan 31, 2021 | |
| 0363-7065-20 | 00363706520 | 2 TUBE in 1 CARTON (0363-7065-20) / 100 g in 1 TUBEMarketed from Apr 9, 2021 | |
| 0363-7065-50 | 00363706550 | 1 TUBE in 1 CARTON (0363-7065-50) / 50 g in 1 TUBEMarketed from Jan 31, 2021 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 Topical Gel 1%
- Generic name (nonproprietary)
- diclofenac sodium topical gel, 1%
- Active ingredients
- Diclofenac sodium — 10 mg/g
- Dosage form
- Gel
- Route
- Topical
- Labeler
- Walgreens Company
- 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 0363-7065_867bef8c-ad27-7567-cfe7-fc27e8cddd4dSPL ID 867bef8c-ad27-7567-cfe7-fc27e8cddd4dSPL set ID 40d0553b-a97a-1315-3fca-8ef38611505eRxCUI 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
N400363706510followed by a unit qualifier and the quantityPackage 00363-7065-10. 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)
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.
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 |
|---|---|---|---|---|
| Diclofenac Sodiumdiclofenac sodium topical gel, 1% | Diclofenac sodium 10 mg/g | GelTopical | Dr. Reddy's Laboratories Inc. | 43598-977 |
| Crcle Diclofenac Sodium Topical Gel 1%diclofenac sodium topical gel 1% | Diclofenac sodium 10 mg/g | GelTopical | Innovus Pharmaceuticals Inc. | 57483-596 |
| Gencare-Arthritis Pain Reliefdiclofenac sodium | Diclofenac sodium .01 g/g | GelTopical | Pioneer Life Sciences, LLC | 72090-017 |
| Diclofenac Sodiumdiclofenac sodium 1% | Diclofenac sodium 10 mg/g | GelTopical | Sportpharm LLC | 85766-240 |
| Diclofenac Sodium Topical Gel 1%diclofenac sodium topical gel, 1% | Diclofenac sodium 10 mg/g | GelTopical | Kroger Company | 30142-025 |
| Dolo-NeuroBion Arthritis Paindiclofenac sodium topical gel, 1% | Diclofenac sodium 10 mg/g | GelTopical | BENARD INDUSTRIES INC | 55959-123 |
| Diclofenac Sodium | Diclofenac sodium 10 mg/g | GelTopical | NuCare Pharmaceuticals,Inc. | 68071-2239 |
| Diclofenac Sodiumdiclofenac sodium 1% | Diclofenac sodium 10 mg/g | GelTopical | Asclemed USA, Inc. | 76420-691 |
| Diclofenac Sodium | Diclofenac sodium 10 mg/g | GelTopical | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0233 |
| Aspercreme Arthritisdiclofenac sodium | Diclofenac sodium .01 g/g | GelTopical | Chattem, Inc. | 41167-0571 |
| Diclofenac Sodium Gel | Diclofenac sodium 10 mg/g | GelTopical | Direct_Rx | 72189-479 |
| Curist Arthritis Reliefdiclofenac sodium | Diclofenac sodium 1 g/100g | GelTopical | Little Pharma, Inc. | 72559-020 |
| Arthritis Paindiclofenac sodium topical gel, 1% | Diclofenac sodium 10 mg/g | GelTopical | Strategic Sourcing Services, LLC | 70677-1125 |
| Diclofenac Sodiumdiclofenac sodium topical gel, 1% | Diclofenac sodium 10 mg/g | GelTopical | BluePoint Laboratories | 68001-621 |
| 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 | Encube Ethicals, Inc. | 21922-044 |
| 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 | NuCare Pharmaceuticals,Inc. | 68071-3483 |
| Diclofenac Sodiumdiclofenac sodium topical gel, 1%, | Diclofenac sodium 10 mg/g | GelTopical | Preferred Pharmaceuticals, Inc. | 68788-7772 |
| Diclofenac Sodium Topical 1%diclofenac sodium | Diclofenac sodium 1 mg/100g | GelTopical | YYBA CORP | 73581-104 |
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