Prescription drug · ANDA
Diclofenac potassium NDC 0480-9435
Diclofenac potassium 25 mg/1 · Capsule, Liquid filled · Oral · TEVA PHARMACEUTICALS, INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0480-9435-89 | 00480943589 | 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (0480-9435-89)Marketed from Mar 24, 2022 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- TEVA PHARMACEUTICALS, INC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204648
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)
- Identifiers
- Product ID 0480-9435_40461510-7592-d588-e063-6394a90a8b9eSPL ID 40461510-7592-d588-e063-6394a90a8b9eSPL set ID d9685883-9d0b-81da-e053-2a95a90ab8d8RxCUI 858342UNII 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
N400480943589followed by a unit qualifier and the quantityPackage 00480-9435-89. 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 are indicated for relief of mild to moderate acute pain in adult and pediatric patients 12 years of age and older. Diclofenac potassium capsules are 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 ANDA 204648
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 | Bryant Ranch Prepack | 63629-4871 |