Prescription drug · ANDA
Diclofenac Potassium NDC 62135-469
Diclofenac potassium 25 mg/1 · Capsule, Liquid filled · Oral · Chartwell RX, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62135-469-12 | 62135046912 | 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (62135-469-12)Marketed from Feb 12, 2023 |
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
- Chartwell RX, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210078
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)
- Identifiers
- Product ID 62135-469_459be997-2951-a7cf-e063-6394a90ad491SPL ID 459be997-2951-a7cf-e063-6394a90ad491SPL set ID 3a837a3e-10b2-4256-b515-80c863318ccbRxCUI 858342UNII L4D5UA6CB4UPC 0362135469122
- 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
N462135046912followed by a unit qualifier and the quantityPackage 62135-0469-12. 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 Capsules is indicated for relief of mild to moderate acute pain in adult patients. Pediatric use information is approved for Assertio Therapeutics Inc's ZIPSOR (diclofenac potassium) Capsules. However, due to Assertio Therapeutics Inc's marketing exclusivity rights, this drug product is not labeled with that information. Diclofenac Potassium Capsules is a non-steroidal anti-inflammatory drug indicated for relief of mild to moderate acute pain in adult patients ( 1 ) ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 210078
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 | Lifsa Drugs LLC | 72336-432 |
| diclofenac potassium | Diclofenac potassium 25 mg/1 | Capsule, Liquid filledOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-840 |
| diclofenac potassium | Diclofenac potassium 25 mg/1 | Capsule, Liquid filledOral | Strides Pharma Science Limited | 64380-841 |
| Diclofenac Potassiumdiclofenac potassium 25 mg | Diclofenac potassium 25 mg/1 | Capsule, Liquid filledOral | PureTek Corporation | 59088-131 |