Prescription drug · ANDA
Diclofenac Sodium (Diclofenac sodium topical gel, 1%,) NDC 76420-091
Diclofenac sodium 10 mg/g · Gel · Topical · Asclemed USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76420-091-01 | 7642000910176420009101 | 100 g in 1 TUBE (76420-091-01)Marketed from Oct 24, 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
- Asclemed USA, Inc.NDC labeler code 76420
- Product type
- Prescription 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 76420-091_b269742f-932d-73f2-e053-2a95a90a3761SPL ID b269742f-932d-73f2-e053-2a95a90a3761SPL set ID 988abe66-0b3b-4c13-87b4-adc913227fc5RxCUI 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
N476420009101followed by a unit qualifier and the quantityPackage 76420-0091-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
Diclofenac sodium topical gel is indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands. Diclofenac sodium topical gel has not been evaluated for use on the spine, hip, or shoulder. Diclofenac sodium topical gel is a non-steroidal anti-inflammatory drug indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands. Diclofenac sodium topical gel was not evaluated for use on joints of the spine, hip, or shoulder. (14.1)
Excerpt only. Read the full label for complete information.
About NDC 76420-091
- What is NDC 76420-091?
- 76420-091 is the product NDC for Diclofenac Sodium, Diclofenac sodium 10 mg/g gel, listed with the FDA by Asclemed USA, 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?
- Asclemed USA, Inc., NDC labeler code 76420. 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 | 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 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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