Prescription drug · NDA AUTHORIZED GENERIC
Diclofenac Potassium NDC 69315-275
Diclofenac potassium 25 mg/1 · Capsule, Liquid filled · Oral · Leading Pharma, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69315-275-20 | 6931502752069315027520 | 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (69315-275-20)Marketed from Mar 24, 2022 |
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 Potassium
- Generic name (nonproprietary)
- diclofenac potassium
- Active ingredients
- Diclofenac potassium — 25 mg/1
- Dosage form
- Capsule, Liquid filled
- Route
- Oral
- Labeler
- Leading Pharma, LLCNDC labeler code 69315
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 022202
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)
- Identifiers
- Product ID 69315-275_9f4d938d-3f9c-41b0-bb9b-82fd4487cf66SPL ID 9f4d938d-3f9c-41b0-bb9b-82fd4487cf66SPL set ID 698690a7-4978-4457-b123-0a670bbab481RxCUI 858342UNII L4D5UA6CB4UPC 0369315275207
- 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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N469315027520followed by a unit qualifier and the quantityPackage 69315-0275-20. 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 Potassium is indicated for relief of mild to moderate acute pain in adult and pediatric patients 12 years of age and older. Diclofenac potassium is a non-steroidal anti-inflammatory drug indicated for relief of mild to moderate acute pain in adult and pediatric patients 12 years of age and older. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 69315-275
- What is NDC 69315-275?
- 69315-275 is the product NDC for Diclofenac Potassium, Diclofenac potassium 25 mg/1 capsule, liquid filled, listed with the FDA by Leading Pharma, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Diclofenac Potassium.
- What is the active ingredient?
- Diclofenac potassium.
- Who is the labeler?
- Leading Pharma, LLC, NDC labeler code 69315. 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 Potassium?
- 67 other product NDCs are listed under this name. See all Diclofenac Potassium NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Diclofenac Potassium 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 Potassium | Diclofenac potassium 75 mg/1 | Tablet, CoatedOral | Advagen Pharma Ltd | 72888-203 | 72888-0203-0072888-0203-0172888-0203-05+1 more |
| Diclofenac Potassiumdiclofenac potassium, film coated | Diclofenac potassium 50 mg/1 | TabletOral | Amerisyn LLC | 87564-011 | 87564-0011-10 |
| Diclofenac Potassiumdiclofenac potassium, film coated | Diclofenac potassium 50 mg/1 | TabletOral | VICI Pharmaceuticals, Inc | 87528-001 | 87528-0001-10 |
| Diclofenac Potassiumdiclofenac potassium 25 mg | Diclofenac potassium 25 mg/1 | Capsule, Liquid filledOral | PureTek Corporation | 59088-131 | 59088-0131-73 |
| Diclofenac Potassium | Diclofenac potassium 50 mg/1 | Powder, For solutionOral | Umedica Laboratories USA Inc. | 60290-061 | 60290-0061-0160290-0061-02 |
| Diclofenac Potassium | Diclofenac potassium 50 mg/1 | Powder, For solutionOral | Nivagen Pharmaceuticals, Inc. | 75834-338 | 75834-0338-0175834-0338-02 |
| Diclofenac Potassiumdiclofenac potassium tablets | Diclofenac potassium 25 mg/1 | Tablet, Film coatedOral | NIVAGEN PHARMACEUTICALS, INC. | 75834-337 | 75834-0337-3075834-0337-60 |
| Diclofenac Potassiumdiclofenac potassium, film coated | Diclofenac potassium 25 mg/1 | TabletOral | Happy Robin, LLC | 87127-802 | 87127-0802-60 |
| Diclofenac Potassium | Diclofenac potassium 25 mg/1 | Capsule, Liquid filledOral | Lifsa Drugs LLC | 72336-432 | 72336-0432-12 |
| Diclofenac Potassium | Diclofenac potassium 50 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8411 | 68788-8411-0168788-8411-0368788-8411-06+1 more |
Other NDCs under NDA 022202
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 Potassium | Diclofenac potassium 25 mg/1 | Capsule, Liquid filledOral | Bryant Ranch Prepack | 71335-2550 |
| Zipsordiclofenac potassium | Diclofenac potassium 25 mg/1 | Capsule, Liquid filledOral | Assertio Therapeutics, Inc. | 13913-008 |
| Zipsordiclofenac potassium | Diclofenac potassium 25 mg/1 | Capsule, Liquid filledOral | Assertio Specialty Pharmaceuticals LLC | 82497-008 |