Over-the-counter drug · ANDA
Diclofenac sodium NDC 69097-720
Diclofenac sodium 10 mg/g · Gel · Topical · Cipla USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69097-720-44 | 69097072044 | 1 TUBE in 1 CARTON (69097-720-44) / 100 g in 1 TUBEMarketed from Aug 5, 2024 |
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 — 10 mg/g
- Dosage form
- Gel
- Route
- Topical
- Labeler
- Cipla USA Inc.
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209903
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)
- Identifiers
- Product ID 69097-720_930f1c44-2aea-41a8-a9d8-feb8e2699b9fSPL ID 930f1c44-2aea-41a8-a9d8-feb8e2699b9fSPL set ID daf52f5a-1bb7-4808-ab98-483ab9e8cfa0RxCUI 855633UNII QTG126297Q
- 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. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N469097072044followed by a unit qualifier and the quantityPackage 69097-0720-44. 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 .
Indications (excerpt from the label)
USES for the temporary relief of arthritis pain ONLY in the following areas: hand, wrist, elbow (upper body areas) foot, ankle, knee (lower body areas) this product may take up to 7 days to work for arthritis pain; it is not for immediate relief. If no pain relief in 7 days, stop use.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 209903
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 10 mg/g | GelTopical | EXELAN PHARMACEUTICALS INC. | 76282-103 |
| Diclofenac Sodium | Diclofenac sodium 10 mg/g | GelTopical | NuCare Pharmaceuticals, Inc. | 68071-3665 |
| Diclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | NuCare Pharmaceuticals, Inc. | 68071-5307 |
| Diclofenac Sodium | Diclofenac sodium 10 mg/g | GelTopical | Quality Care Products, LLC | 83008-037 |
| Diclofenac Sodium | Diclofenac sodium 10 mg/g | GelTopical | A-S Medication Solutions | 50090-4030 |
| Diclofenac Sodium | Diclofenac sodium 10 mg/g | GelTopical | A-S Medication Solutions | 50090-4020 |