Prescription drug · ANDA
Diclofenac Potassium NDC 80425-0457
Diclofenac potassium 50 mg/1 · Tablet, Film coated · Oral · Advanced Rx of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0457-1 | 8042504570180425045701 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0457-1)Marketed from Oct 21, 2024 | |
| 80425-0457-2 | 8042504570280425045702 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0457-2)Marketed from Oct 21, 2024 | |
| 80425-0457-3 | 8042504570380425045703 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0457-3)Marketed from Oct 21, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 50 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Advanced Rx of Tennessee, LLCNDC labeler code 80425
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215787
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)
- Identifiers
- Product ID 80425-0457_295d5e97-b95f-d7d1-e063-6394a90af14fSPL ID 295d5e97-b95f-d7d1-e063-6394a90af14fSPL set ID 295d5dab-8890-d76e-e063-6394a90ad402RxCUI 855942UNII L4D5UA6CB4
- 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
N480425045701followed by a unit qualifier and the quantityPackage 80425-0457-01. 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)
INDICATIONS AND USAGE Carefully consider the potential benefits and risks of diclofenac potassium tablets and other treatment options before deciding to use diclofenac potassium tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS: Gastrointestinal Bleeding, Ulceration, and Perforation) . Diclofenac potassium tablets are indicated: for treatment of primary dysmenorrhea for relief of mild to moderate pain for relief of the signs and symptoms of osteoarthritis for relief of the signs and symptoms of rheumatoid arthritis
Excerpt only. Read the full label for complete information.
About NDC 80425-0457
- What is NDC 80425-0457?
- 80425-0457 is the product NDC for Diclofenac Potassium, Diclofenac potassium 50 mg/1 tablet, film coated, listed with the FDA by Advanced Rx of Tennessee, LLC. It has 3 package NDCs, 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?
- Advanced Rx of Tennessee, LLC, NDC labeler code 80425. 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 ANDA 215787
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 Potassiumdiclofenac potassium, film coated | Diclofenac potassium 25 mg/1 | TabletOral | Cintex Services, LLC | 24470-924 |
| Diclofenac Potassiumdiclofenac potassium, film coated | Diclofenac potassium 50 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-912 |
| Diclofenac Potassiumdiclofenac potassium, film coated | Diclofenac potassium 50 mg/1 | TabletOral | Amici Pharma, Inc | 69292-552 |
| Diclofenac Potassium | Diclofenac potassium 50 mg/1 | Tablet, Film coatedOral | Doc Rx | 69306-750 |
| Diclofenac Potassium | Diclofenac potassium 50 mg/1 | Tablet, Film coatedOral | SOLA Pharmaceuticals, LLC | 70512-750 |
| Diclofenac Potassium | Diclofenac potassium 50 mg/1 | Tablet, Film coatedOral | SOLA Pharmaceuticals, LLC | 70512-900 |
| Diclofenac Potassiumdiclofenac potassium, film coated | Diclofenac potassium 50 mg/1 | TabletOral | Havix Group Inc d-b-a Aavis Pharmaceuticals | 71337-046 |
| Diclofenac Potassiumdiclofenac potassium, film coated | Diclofenac potassium 25 mg/1 | TabletOral | INA Pharmaceutics Inc, | 74157-016 |
| Diclofenac Potassium | Diclofenac potassium 50 mg/1 | Tablet, Film coatedOral | Advanced Rx of Tennessee, LLC | 80425-0456 |
| Diclofenac Potassium | Diclofenac potassium 50 mg/1 | Tablet, Film coatedOral | PHOENIX RX LLC | 85509-1900 |
| Diclofenac Potassium | Diclofenac potassium 50 mg/1 | Tablet, Film coatedOral | Phoenix RX LLC | 85509-2750 |
| Diclofenac Potassiumdiclofenac potassium, film coated | Diclofenac potassium 25 mg/1 | TabletOral | Happy Robin, LLC | 87127-802 |
| Diclofenac Potassiumdiclofenac potassium, film coated | Diclofenac potassium 50 mg/1 | TabletOral | VICI Pharmaceuticals, Inc | 87528-001 |
| Diclofenac Potassiumdiclofenac potassium, film coated | Diclofenac potassium 50 mg/1 | TabletOral | Amerisyn LLC | 87564-011 |