Prescription drug · ANDA
Diclofenac Potassium NDC 70518-3538
Diclofenac potassium 50 mg/1 · Tablet, Film coated · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-3538-3 | 7051835380370518353803 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3538-3)Marketed from Apr 6, 2023 |
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
- REMEDYREPACK INC.NDC labeler code 70518
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215585
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)
- Identifiers
- Product ID 70518-3538_5472ba66-47b6-8776-e063-6294a90abc82SPL ID 5472ba66-47b6-8776-e063-6294a90abc82SPL set ID c4976d69-ca06-4263-9240-6fd8b44a9b6dRxCUI 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
N470518353803followed by a unit qualifier and the quantityPackage 70518-3538-03. 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 70518-3538
- What is NDC 70518-3538?
- 70518-3538 is the product NDC for Diclofenac Potassium, Diclofenac potassium 50 mg/1 tablet, film coated, listed with the FDA by REMEDYREPACK INC.. 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?
- REMEDYREPACK INC., NDC labeler code 70518. 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 215585
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 50 mg/1 | Tablet, Film coatedOral | AvKARE | 42291-042 |
| Diclofenac Potassium | Diclofenac potassium 50 mg/1 | Tablet, Film coatedOral | Ingenus Pharmaceuticals, LLC | 50742-279 |
| Diclofenac Potassium | Diclofenac potassium 50 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8697 |
| Diclofenac Potassium | Diclofenac potassium 50 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2530 |