Prescription drug · ANDA
Diclofenac Potassium NDC 50090-5893
Diclofenac potassium 50 mg/1 · Tablet, Coated · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-5893-0 | 50090589300 | 30 TABLET, COATED in 1 BOTTLE (50090-5893-0)Marketed from Jan 12, 2022 | |
| 50090-5893-1 | 50090589301 | 21 TABLET, COATED in 1 BOTTLE (50090-5893-1)Marketed from Jan 16, 2022 | |
| 50090-5893-3 | 50090589303 | 45 TABLET, COATED in 1 BOTTLE (50090-5893-3)Marketed from Jan 16, 2022 | |
| 50090-5893-4 | 50090589304 | 90 TABLET, COATED in 1 BOTTLE (50090-5893-4)Marketed from Jan 16, 2022 |
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, Coated
- Route
- Oral
- Labeler
- A-S Medication Solutions
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075229
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)
- Identifiers
- Product ID 50090-5893_b6546725-2742-4aef-a3cf-0c53aeaea638SPL ID b6546725-2742-4aef-a3cf-0c53aeaea638SPL set ID 112e7c94-23c8-451e-ae71-eb89a6eb2cb2RxCUI 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
N450090589300followed by a unit qualifier and the quantityPackage 50090-5893-00. 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.
Other NDCs under ANDA 075229
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 | Tablet, CoatedOral | Trifluent Pharma LLC | 73352-086 |
| Diclofenac Potassium | Diclofenac potassium 50 mg/1 | Tablet, CoatedOral | Coupler LLC | 67046-1522 |
| Diclofenac Potassium | Diclofenac potassium 50 mg/1 | Tablet, CoatedOral | Advagen Pharma Ltd | 72888-073 |
| Diclofenac Potassium | Diclofenac potassium 50 mg/1 | Tablet, CoatedOral | Northwind Health Company, LLC | 51655-230 |
| Diclofenac Potassium | Diclofenac potassium 25 mg/1 | Tablet, CoatedOral | Advagen Pharma Ltd | 72888-086 |
| Diclofenac Potassium | Diclofenac potassium 50 mg/1 | Tablet, CoatedOral | Proficient Rx LP | 82804-010 |
| Diclofenac Potassium | Diclofenac potassium 50 mg/1 | Tablet, CoatedOral | NuCare Pharmaceuticals,Inc. | 68071-2625 |
| Diclofenac Potassium | Diclofenac potassium 75 mg/1 | Tablet, CoatedOral | Advagen Pharma Ltd | 72888-203 |
| Diclofenac Potassium | Diclofenac potassium 25 mg/1 | Tablet, CoatedOral | INA Pharmaceutics Inc | 74157-007 |
| Diclofenac Potassium | Diclofenac potassium 50 mg/1 | Tablet, CoatedOral | Bryant Ranch Prepack | 71335-2052 |