Prescription drug · ANDA
Diclofenac potassium NDC 31722-046
Diclofenac potassium 50 mg/1 · Powder, For solution · Oral · Camber Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 31722-046-31 | 31722004631 | 1 POWDER, FOR SOLUTION in 1 PACKET (31722-046-31)Marketed from Mar 4, 2022 | |
| 31722-046-32 | 31722004632 | 9 POWDER, FOR SOLUTION in 1 CARTON (31722-046-32)Marketed from Mar 4, 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 — 50 mg/1
- Dosage form
- Powder, For solution
- Route
- Oral
- Labeler
- Camber Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215375
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)
- Identifiers
- Product ID 31722-046_2d0e1b57-79e2-61da-e063-6394a90a214eSPL ID 2d0e1b57-79e2-61da-e063-6394a90a214eSPL set ID 9261a9d6-f772-41a2-ac99-8608c04c355bRxCUI 859063UNII L4D5UA6CB4UPC 0331722046329
- 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
N431722004631followed by a unit qualifier and the quantityPackage 31722-0046-31. 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 for oral solution is indicated for the acute treatment of migraine attacks with or without aura in adults (18 years of age or older). Limitations of Use: • Diclofenac potassium for oral solution is not indicated for the prophylactic therapy of migraine. • The safety and effectiveness of diclofenac potassium for oral solution have not been established for cluster headache, which is present in an older, predominantly male population. Diclofenac potassium for oral solution is a non-steroidal anti-inflammatory drug (NSAID) indicated for the acute treatment of migraine attacks with or without aura in adults 18 years of age or older ( 1 ) Limitations of Use ( 1 ): • Diclofenac…
Excerpt only. Read the full label for complete information.