Prescription drug · NDA
Zipsor (Diclofenac potassium) NDC 82497-008
Diclofenac potassium 25 mg/1 · Capsule, Liquid filled · Oral · Assertio Specialty Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82497-008-12 | 8249700081282497000812 | 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (82497-008-12)Marketed from Aug 24, 2026 |
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 Specialty Pharmaceuticals LLCNDC labeler code 82497
- 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 82497-008_5a0953ef-56b9-08cb-e063-6294a90a45b5SPL ID 5a0953ef-56b9-08cb-e063-6294a90a45b5SPL set ID ed2a8868-78eb-47b8-8f46-0f70e2891e07RxCUI 858342, 858346UNII L4D5UA6CB4UPC 0382497008128
- 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
N482497000812followed by a unit qualifier and the quantityPackage 82497-0008-12. 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.
About NDC 82497-008
- What is NDC 82497-008?
- 82497-008 is the product NDC for Zipsor (diclofenac potassium), Diclofenac potassium 25 mg/1 capsule, liquid filled, listed with the FDA by Assertio Specialty Pharmaceuticals LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Zipsor (Diclofenac potassium).
- What is the active ingredient?
- Diclofenac potassium.
- Who is the labeler?
- Assertio Specialty Pharmaceuticals LLC, NDC labeler code 82497. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Zipsor?
- 1 other product NDC are listed under this name. See all Zipsor NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Zipsor products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Zipsordiclofenac potassium | Diclofenac potassium 25 mg/1 | Capsule, Liquid filledOral | Assertio Therapeutics, Inc. | 13913-008 | 13913-0008-12 |
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 |
| Diclofenac Potassium | Diclofenac potassium 25 mg/1 | Capsule, Liquid filledOral | Bryant Ranch Prepack | 71335-2550 |
| Zipsordiclofenac potassium | Diclofenac potassium 25 mg/1 | Capsule, Liquid filledOral | Assertio Therapeutics, Inc. | 13913-008 |