Prescription drug · NDA
Flector (Diclofenac epolamine) NDC 71858-0405
Diclofenac epolamine .013 g/1 · System · Topical · IBSA Pharma Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71858-0405-2 | 71858040502 | 1 POUCH in 1 CARTON (71858-0405-2) / 2 SYSTEM in 1 POUCH (71858-0405-1)Marketed from Nov 1, 2020 · Sample package | |
| 71858-0405-5 | 71858040505 | 6 POUCH in 1 CARTON (71858-0405-5) / 5 SYSTEM in 1 POUCH (71858-0405-4)Marketed from Nov 1, 2020 | |
| 71858-0405-6 | 71858040506 | 3 POUCH in 1 CARTON (71858-0405-6) / 5 SYSTEM in 1 POUCH (71858-0405-4)Marketed from Feb 1, 2026 |
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)
- Flector
- Generic name (nonproprietary)
- diclofenac epolamine
- Active ingredients
- Diclofenac epolamine — .013 g/1
- Dosage form
- System
- Route
- Topical
- Labeler
- IBSA Pharma Inc.NDC labeler code 71858
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021234
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)
- Identifiers
- Product ID 71858-0405_41a95307-60af-f937-e063-6394a90aa82aSPL ID 41a95307-60af-f937-e063-6394a90aa82aSPL set ID 1f19a016-c4fc-43c5-9990-e5f2e2776a82RxCUI 855626, 855628UNII 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
N471858040502followed by a unit qualifier and the quantityPackage 71858-0405-02. 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)
FLECTOR ® is indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions in adults and pediatric patients 6 years and older. FLECTOR is a nonsteroidal anti-inflammatory drug (NSAID) and is indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions in adults and pediatric patients 6 years and older. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 71858-0405
- What is NDC 71858-0405?
- 71858-0405 is the product NDC for Flector (diclofenac epolamine), Diclofenac epolamine .013 g/1 system, listed with the FDA by IBSA Pharma Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Flector (Diclofenac epolamine).
- What is the active ingredient?
- Diclofenac epolamine.
- Who is the labeler?
- IBSA Pharma Inc., NDC labeler code 71858. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Flector?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
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 | HAWAII REPACK, INC. | 85534-0034 |
| Diclofenac Epolamine | Diclofenac epolamine .013 g/1 | SystemTopical | Asclemed USA, Inc. | 76420-673 |
| Diclofenac Epolamine | Diclofenac epolamine .013 g/1 | SystemTopical | YARAL Pharma Inc. | 82347-0405 |
| 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 |
| diclofenac epolamine | Diclofenac epolamine .013 g/1 | SystemTopical | Teva Pharmaceuticals USA Inc. | 0093-3727 |
| diclofenac epolamine | Diclofenac epolamine .013 g/1 | SystemTopical | ASCLEMED USA INC. | 76420-409 |
| Diclofenac Epolamine | Diclofenac epolamine .013 g/1 | SystemTopical | Phoenix RX LLC | 85509-1405 |
| diclofenac epolamine | Diclofenac epolamine .013 g/1 | SystemTopical | Advanced Rx of Tennessee, LLC | 80425-0364 |
| Diclofenac Epolamine | Diclofenac epolamine .013 g/1 | SystemTopical | Preferred Pharmaceuticals Inc. | 68788-4115 |
| diclofenac epolamine | Diclofenac epolamine .013 g/1 | SystemTopical | Quality Care Products, LLC | 83008-036 |
| Diclofenac Epolamine | Diclofenac epolamine .013 g/1 | SystemTopical | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0403 |