Prescription drug · ANDA
Diclofenac Sodium (diclofenac sodium topical) NDC 82804-250
Diclofenac sodium 30 mg/g · Gel · Topical · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82804-250-00 | 82804025000 | 1 TUBE in 1 CARTON (82804-250-00) / 100 g in 1 TUBEMarketed from Oct 23, 2025 |
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 topical
- Active ingredients
- Diclofenac sodium — 30 mg/g
- Dosage form
- Gel
- Route
- Topical
- Labeler
- Proficient Rx LP
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212351
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)
- Identifiers
- Product ID 82804-250_9f1af144-5910-4484-ba6e-6c87e0efba45SPL ID 9f1af144-5910-4484-ba6e-6c87e0efba45SPL set ID 140a2c64-4996-4da3-b10f-1b8235ebde9dRxCUI 855642UNII QTG126297QUPC 0382804250004
- 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
N482804025000followed by a unit qualifier and the quantityPackage 82804-0250-00. 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)
Diclofenac sodium topical gel is indicated for the topical treatment of actinic keratoses (AK). Diclofenac sodium topical gel is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the topical treatment of actinic keratoses (AK). ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 212351
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 Sodiumdiclofenac sodium topical | Diclofenac sodium 30 mg/g | GelTopical | Medsource Pharmaceuticals | 45865-260 |
| Diclofenac Sodiumdiclofenac sodium topical | Diclofenac sodium 30 mg/g | GelTopical | Alembic Pharmaceuticals Inc. | 62332-581 |
| Diclofenac Sodiumdiclofenac sodium topical | Diclofenac sodium 30 mg/g | GelTopical | REMEDYREPACK INC. | 70518-3779 |
| Diclofenac Sodium Gel | Diclofenac sodium 30 mg/g | GelTopical | Direct_Rx | 72189-473 |
| Diclofenac Sodiumdiclofenac sodium topical | Diclofenac sodium 30 mg/g | GelTopical | PHOENIX RX LLC | 85509-1581 |
| Diclofenac Sodiumdiclofenac sodium topical | Diclofenac sodium 30 mg/g | GelTopical | Alembic Pharmaceuticals Limited | 46708-581 |
| Diclofenac Sodiumdiclofenac sodium topical | Diclofenac sodium 30 mg/g | GelTopical | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0338 |
| Diclofenac Sodiumdiclofenac sodium topical | Diclofenac sodium 30 mg/g | GelTopical | ASCLEMED USA INC. | 87063-165 |
| Diclofenac Sodiumdiclofenac sodium topical | Diclofenac sodium 30 mg/g | GelTopical | Preferred Pharmaceuticals Inc. | 68788-8456 |