Prescription drug · NDA
Zipsor (diclofenac potassium) NDC 13913-008
Diclofenac potassium 25 mg/1 · Capsule, Liquid filled · Oral · Assertio Therapeutics, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 13913-008-12 | 13913000812 | 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (13913-008-12)Marketed from Dec 1, 2015 |
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)
- Zipsor
- Generic name (nonproprietary)
- diclofenac potassium
- Active ingredients
- Diclofenac potassium — 25 mg/1
- Dosage form
- Capsule, Liquid filled
- Route
- Oral
- Labeler
- Assertio Therapeutics, Inc.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022202
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)
- Identifiers
- Product ID 13913-008_73f6a60d-3089-4936-84df-8c28c49cb441SPL ID 73f6a60d-3089-4936-84df-8c28c49cb441SPL set ID c982eca0-fc41-11e1-a9c8-0002a5d5c51bRxCUI 858342, 858346UNII L4D5UA6CB4UPC 0313913008125
- 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
N413913000812followed by a unit qualifier and the quantityPackage 13913-0008-12. 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)
ZIPSOR is indicated for relief of mild to moderate acute pain in adult and pediatric patients 12 years of age and older. ZIPSOR is a non-steroidal anti-inflammatory drug indicated for relief of mild to moderate acute pain in adult and pediatric patients 12 years of age and older. ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 022202
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 | Leading Pharma, LLC | 69315-275 |
| Zipsordiclofenac potassium | Diclofenac potassium 25 mg/1 | Capsule, Liquid filledOral | Assertio Specialty Pharmaceuticals LLC | 82497-008 |
| Diclofenac Potassium | Diclofenac potassium 25 mg/1 | Capsule, Liquid filledOral | Bryant Ranch Prepack | 71335-2550 |