Prescription drug · NDA AUTHORIZED GENERIC
diclofenac epolamine NDC 80425-0364
Diclofenac epolamine .013 g/1 · System · Topical · Advanced Rx of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0364-1 | 80425036401 | 6 POUCH in 1 CARTON (80425-0364-1) / 5 SYSTEM in 1 POUCHMarketed from Nov 27, 2023 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 epolamine
- Generic name (nonproprietary)
- diclofenac epolamine
- Active ingredients
- Diclofenac epolamine — .013 g/1
- Dosage form
- System
- Route
- Topical
- Labeler
- Advanced Rx of Tennessee, LLCNDC labeler code 80425
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 021234
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)
- Identifiers
- Product ID 80425-0364_2a994ea2-2577-6513-e063-6394a90a7bc2SPL ID 2a994ea2-2577-6513-e063-6394a90a7bc2SPL set ID 08b8737f-b6d2-77da-e063-6294a90a1a3eRxCUI 855626UNII X5F8EKL9ZG
- 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
N480425036401followed by a unit qualifier and the quantityPackage 80425-0364-01. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
About NDC 80425-0364
- What is NDC 80425-0364?
- 80425-0364 is the product NDC for diclofenac epolamine, Diclofenac epolamine .013 g/1 system, listed with the FDA by Advanced Rx of Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- diclofenac epolamine.
- What is the active ingredient?
- Diclofenac epolamine.
- Who is the labeler?
- Advanced Rx of Tennessee, LLC, NDC labeler code 80425. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for diclofenac epolamine?
- 10 other product NDCs are listed under this name. See all diclofenac epolamine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other diclofenac epolamine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Diclofenac Epolamine | Diclofenac epolamine .013 g/1 | SystemTopical | Preferred Pharmaceuticals Inc. | 68788-4115 | 68788-4115-03 |
| Diclofenac Epolamine | Diclofenac epolamine .013 g/1 | SystemTopical | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0403 | 80425-0403-01 |
| diclofenac epolamine | Diclofenac epolamine .013 g/1 | SystemTopical | Quality Care Products, LLC | 83008-036 | 83008-0036-30 |
| Diclofenac Epolamine | Diclofenac epolamine .013 g/1 | SystemTopical | Asclemed USA, Inc. | 76420-673 | 76420-0673-30 |
| Diclofenac Epolamine | Diclofenac epolamine .013 g/1 | SystemTopical | YARAL Pharma Inc. | 82347-0405 | 82347-0405-0582347-0405-06 |
| Diclofenac Epolamine | Diclofenac epolamine .013 g/1 | SystemTopical | Phoenix RX LLC | 85509-1405 | 85509-1405-03 |
| Diclofenac Epolamine | Diclofenac epolamine .013 g/1 | SystemTopical | HAWAII REPACK, INC. | 85534-0034 | 85534-0034-00 |
| Diclofenac Epolamine | Diclofenac epolamine .013 g/1 | SystemTopical | Sportpharm LLC | 85766-265 | 85766-0265-1585766-0265-30 |
| diclofenac epolamine | Diclofenac epolamine .013 g/1 | SystemTopical | Teva Pharmaceuticals USA Inc. | 0093-3727 | 00093-3727-55 |
| diclofenac epolamine | Diclofenac epolamine .013 g/1 | SystemTopical | ASCLEMED USA INC. | 76420-409 | 76420-0409-30 |
Other NDCs under NDA 021234
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 epolamine | Diclofenac epolamine .013 g/1 | SystemTopical | Teva Pharmaceuticals USA Inc. | 0093-3727 |
| Diclofenac Epolamine | Diclofenac epolamine .013 g/1 | SystemTopical | Preferred Pharmaceuticals Inc. | 68788-4115 |
| diclofenac epolamine | Diclofenac epolamine .013 g/1 | SystemTopical | ASCLEMED USA INC. | 76420-409 |
| Diclofenac Epolamine | Diclofenac epolamine .013 g/1 | SystemTopical | Asclemed USA, Inc. | 76420-673 |
| Diclofenac Epolamine | Diclofenac epolamine .013 g/1 | SystemTopical | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0403 |
| Diclofenac Epolamine | Diclofenac epolamine .013 g/1 | SystemTopical | YARAL Pharma Inc. | 82347-0405 |
| diclofenac epolamine | Diclofenac epolamine .013 g/1 | SystemTopical | Quality Care Products, LLC | 83008-036 |
| Diclofenac Epolamine | Diclofenac epolamine .013 g/1 | SystemTopical | Phoenix RX LLC | 85509-1405 |
| Diclofenac Epolamine | Diclofenac epolamine .013 g/1 | SystemTopical | HAWAII REPACK, INC. | 85534-0034 |
| Diclofenac Epolamine | Diclofenac epolamine .013 g/1 | SystemTopical | Sportpharm LLC | 85766-265 |
| Diclox Patch 30CTdiclofenac epolamine 1.3% patch | Diclofenac epolamine .013 g/1 | SystemTopical | Injecta Medcial LLC | 87234-0405 |
| Flectordiclofenac epolamine | Diclofenac epolamine .013 g/1 | SystemTopical | IBSA Pharma Inc. | 71858-0405 |