Prescription drug · ANDA
Diclofenac Sodium NDC 76420-861
Diclofenac sodium 20 mg/g · Solution · Topical · Asclemed USA, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76420-861-04 | 7642008610476420086104 | 1 BOTTLE in 1 CARTON (76420-861-04) / 112 g in 1 BOTTLEMarketed from Oct 4, 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)
- Diclofenac Sodium
- Generic name (nonproprietary)
- diclofenac sodium
- Active ingredients
- Diclofenac sodium — 20 mg/g
- Dosage form
- Solution
- Route
- Topical
- Labeler
- Asclemed USA, IncNDC labeler code 76420
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213040
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)
- Identifiers
- Product ID 76420-861_239fc4df-8f2c-e524-e063-6394a90a2baeSPL ID 239fc4df-8f2c-e524-e063-6394a90a2baeSPL set ID 2e3e6de9-7e07-4df3-9fea-ac50ddcde840RxCUI 1487074UNII 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
N476420086104followed by a unit qualifier and the quantityPackage 76420-0861-04. 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)
1. INDICATIONS AND USAGE Diclofenac sodium topical solution is indicated for the treatment of the pain of osteoarthritis of the knee(s). Diclofenac sodium topical solution is a nonsteroidal anti-inflammatory drug indicated for the treatment of the pain of osteoarthritis of the knee(s). (1)
Excerpt only. Read the full label for complete information.
About NDC 76420-861
- What is NDC 76420-861?
- 76420-861 is the product NDC for Diclofenac Sodium, Diclofenac sodium 20 mg/g solution, 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.
- 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 213040
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 Sodium | Diclofenac sodium 20 mg/g | SolutionTopical | Aurolife Pharma LLC | 13107-269 |
| Diclofenac Sodium | Diclofenac sodium 20 mg/g | SolutionTopical | A-S Medication Solutions | 50090-7632 |
| Diclofenac Sodium | Diclofenac sodium 20 mg/g | SolutionTopical | Preferred Pharmaceuticals Inc. | 68788-8541 |
| Diclofenac Sodium | Diclofenac sodium 20 mg/g | SolutionTopical | NorthStar Rx LLC | 72603-207 |
| Diclofenac Sodium | Diclofenac sodium 20 mg/g | SolutionTopical | Proficient Rx LP | 82804-074 |
| Diclofenac Sodium | Diclofenac sodium 20 mg/g | SolutionTopical | Proficient Rx LP | 82804-160 |
| Diclofenac Sodium Topical Solution | Diclofenac sodium 20 mg/g | SolutionTopical | Direct_Rx | 72189-546 |