Prescription drug · ANDA
Diclofenac Sodium NDC 72888-111
Diclofenac sodium 75 mg/1 · Tablet, Delayed release · Oral · Advagen Pharma Ltd
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72888-111-00 | 72888011100 | 1000 TABLET, DELAYED RELEASE in 1 BOTTLE (72888-111-00)Marketed from Jun 1, 2023 | |
| 72888-111-01 | 72888011101 | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (72888-111-01)Marketed from Jun 1, 2023 | |
| 72888-111-05 | 72888011105 | 500 TABLET, DELAYED RELEASE in 1 BOTTLE (72888-111-05)Marketed from Aug 1, 2023 | |
| 72888-111-30 | 72888011130 | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (72888-111-30)Marketed from Jun 1, 2023 | |
| 72888-111-60 | 72888011160 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (72888-111-60)Marketed from Jun 1, 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 Sodium
- Generic name (nonproprietary)
- diclofenac sodium
- Active ingredients
- Diclofenac sodium — 75 mg/1
- Dosage form
- Tablet, Delayed release
- Route
- Oral
- Labeler
- Advagen Pharma Ltd
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216548
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)
- Identifiers
- Product ID 72888-111_3904a832-bc2f-1d96-e063-6294a90a0cd0SPL ID 3904a832-bc2f-1d96-e063-6294a90a0cd0SPL set ID ac2b4060-a5da-4ddf-a734-2ff58a1f98c9RxCUI 855664, 855906, 855926UNII QTG126297QUPC 0372888110608, 0372888111001, 0372888110059, 0372888111056, 0372888109015, 0372888109008, 0372888110301, 0372888111308, 0372888109602, 0372888110004, 0372888111605, 0372888109053, 0372888109305, 0372888110011, 0372888111018
- 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
N472888011100followed by a unit qualifier and the quantityPackage 72888-0111-00. 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)
INDICATIONS AND USAGE Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation ). Diclofenac sodium delayed-release tablets are indicated: for relief of the signs and symptoms of osteoarthritis for relief of the signs and symptoms of rheumatoid arthritis for acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 216548
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 Sodium | Diclofenac sodium 75 mg/1 | Tablet, Delayed releaseOral | A-S Medication Solutions | 50090-7646 |
| Diclofenac Sodium | Diclofenac sodium 75 mg/1 | Tablet, Delayed releaseOral | A-S Medication Solutions | 50090-7647 |
| Diclofenac Sodium | Diclofenac sodium 75 mg/1 | Tablet, Delayed releaseOral | Redpharm Drug | 67296-2151 |
| Diclofenac Sodium | Diclofenac sodium 75 mg/1 | Tablet, Delayed releaseOral | Bryant Ranch Prepack | 71335-2684 |
| Diclofenac Sodium | Diclofenac sodium 25 mg/1 | Tablet, Delayed releaseOral | Advagen Pharma Ltd | 72888-109 |
| Diclofenac Sodium | Diclofenac sodium 50 mg/1 | Tablet, Delayed releaseOral | Advagen Pharma Ltd | 72888-110 |
| Diclofenac Sodium | Diclofenac sodium 25 mg/1 | Tablet, Delayed releaseOral | NorthStar Rx LLC | 72603-600 |
| Diclofenac Sodium | Diclofenac sodium 50 mg/1 | Tablet, Delayed releaseOral | NorthStar Rx LLC | 72603-601 |
| Diclofenac Sodium | Diclofenac sodium 75 mg/1 | Tablet, Delayed releaseOral | NorthStar Rx LLC | 72603-604 |