Prescription drug · ANDA
Diclofenac Sodium (Diclofenac sodium topical) NDC 80425-0338
Diclofenac sodium 30 mg/g · Gel · Topical · Advanced Rx Pharmacy of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0338-1 | 8042503380180425033801 | 1 TUBE in 1 CARTON (80425-0338-1) / 100 g in 1 TUBEMarketed from May 19, 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 Sodium
- Generic name (nonproprietary)
- diclofenac sodium topical
- Active ingredients
- Diclofenac sodium — 30 mg/g
- Dosage form
- Gel
- Route
- Topical
- Labeler
- Advanced Rx Pharmacy of Tennessee, LLCNDC labeler code 80425
- 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 80425-0338_2a9ba8f4-6cf2-e827-e063-6394a90a0300SPL ID 2a9ba8f4-6cf2-e827-e063-6394a90a0300SPL set ID fc0e6a51-bec3-f7ee-e053-6394a90ada9aRxCUI 855642UNII 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
N480425033801followed by a unit qualifier and the quantityPackage 80425-0338-01. 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
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Diclofenac sodium topical gel is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the topical treatment of actinic keratoses (AK). ( 1 ) Diclofenac sodium topical gel is indicated for the topical treatment of actinic keratoses (AK).
Excerpt only. Read the full label for complete information.
About NDC 80425-0338
- What is NDC 80425-0338?
- 80425-0338 is the product NDC for Diclofenac Sodium (diclofenac sodium topical), Diclofenac sodium 30 mg/g gel, listed with the FDA by Advanced Rx Pharmacy of Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Diclofenac Sodium (Diclofenac Sodium Topical).
- What is the active ingredient?
- Diclofenac sodium.
- Who is the labeler?
- Advanced Rx Pharmacy 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 Sodium?
- 241 other product NDCs are listed under this name. See all Diclofenac Sodium NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Diclofenac Sodium 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 Sodiumdiclofenac sodium topical gel, 1% | Diclofenac sodium 10 mg/g | GelTopical | IPG Pharmaceuticals, inc. | 71085-084 | 71085-0084-03 |
| Diclofenac Sodium | Diclofenac sodium 10 mg/g | GelTopical | Target Corporation | 11673-028 | 11673-0028-1011673-0028-15 |
| Diclofenac Sodium | Diclofenac sodium 75 mg/1 | Tablet, Delayed releaseOral | Northwind Health Company, LLC | 82868-114 | 82868-0114-30 |
| Diclofenac Sodium | Diclofenac sodium 10 mg/g | GelTopical | Preferred Pharmaceuticals Inc. | 68788-4135 | 68788-4135-01 |
| Diclofenac Sodium | Diclofenac sodium 100 mg/1 | Tablet, Film coated, Extended releaseOral | Aurobindo Pharma Limited | 84386-103 | 84386-0103-01 |
| Diclofenac Sodium | Diclofenac sodium 50 mg/1 | Tablet, Delayed releaseOral | REMEDYREPACK INC. | 70518-4694 | 70518-4694-00 |
| Diclofenac sodium | Diclofenac sodium 30 mg/g | GelTopical | Preferred Pharmaceuticals Inc. | 68788-4118 | 68788-4118-01 |
| Diclofenac Sodium | Diclofenac sodium 10 mg/g | GelTopical | Preferred Pharmaceuticals Inc. | 68788-4335 | 68788-4335-01 |
| Diclofenac Sodium | Diclofenac sodium 25 mg/1 | Tablet, Delayed releaseOral | Umedica Laboratories USA Inc. | 60290-082 | 60290-0082-01 |
| Diclofenac Sodium | Diclofenac sodium 50 mg/1 | Tablet, Delayed releaseOral | Umedica Laboratories USA Inc. | 60290-083 | 60290-0083-0160290-0083-0260290-0083-03+1 more |
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 Limited | 46708-581 |
| 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 | Preferred Pharmaceuticals Inc. | 68788-8456 |
| Diclofenac Sodiumdiclofenac sodium topical | Diclofenac sodium 30 mg/g | GelTopical | REMEDYREPACK INC. | 70518-3779 |
| Diclofenac Sodiumdiclofenac sodium topical | Diclofenac sodium 30 mg/g | GelTopical | Proficient Rx LP | 82804-250 |
| 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 | ASCLEMED USA INC. | 87063-165 |
| Diclofenac Sodium Gel | Diclofenac sodium 30 mg/g | GelTopical | Direct_Rx | 72189-473 |