Prescription drug · ANDA
Diclofenac Sodium 1.5% (Diclofenac sodium topical) NDC 70512-038
Diclofenac sodium 16.05 mg/mL · Solution · Topical · SOLA Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70512-038-05 | 70512003805 | 1 BOTTLE in 1 CARTON (70512-038-05) / 150 mL in 1 BOTTLEMarketed from Jun 4, 2021 |
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 1.5%
- Generic name (nonproprietary)
- diclofenac sodium topical
- Active ingredients
- Diclofenac sodium — 16.05 mg/mL
- Dosage form
- Solution
- Route
- Topical
- Labeler
- SOLA PharmaceuticalsNDC labeler code 70512
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204132
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)
- Identifiers
- Product ID 70512-038_457256fd-2abe-2c5a-e063-6394a90a84c0SPL ID 457256fd-2abe-2c5a-e063-6394a90a84c0SPL set ID c3f33952-44a8-71b2-e053-2a95a90abda2RxCUI 857700UNII 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
N470512003805followed by a unit qualifier and the quantityPackage 70512-0038-05. 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 is indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s) (1). Diclofenac sodium is indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s) (1).
Excerpt only. Read the full label for complete information.
About NDC 70512-038
- What is NDC 70512-038?
- 70512-038 is the product NDC for Diclofenac Sodium 1.5% (diclofenac sodium topical), Diclofenac sodium 16.05 mg/mL solution, listed with the FDA by SOLA Pharmaceuticals. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Diclofenac Sodium 1.5% (Diclofenac Sodium Topical).
- What is the active ingredient?
- Diclofenac sodium.
- Who is the labeler?
- SOLA Pharmaceuticals, NDC labeler code 70512. 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 1.5%?
- 3 other product NDCs are listed under this name. See all Diclofenac Sodium 1.5% 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 1.5% 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 Sodium 1.5%diclofenac sodium topical | Diclofenac sodium 16.05 mg/mL | SolutionTopical | Preferred Pharmaceuticals Inc. | 68788-8084 | — |
| Diclofenac Sodium 1.5%diclofenac sodium topical | Diclofenac sodium 16.05 mg/mL | SolutionTopical | Proficient Rx LP | 71205-640 | 71205-0640-15 |
| Diclofenac Sodium 1.5%diclofenac sodium topical | Diclofenac sodium 16.05 mg/mL | SolutionTopical | PHOENIX RX LLC | 85509-1038 | 85509-1038-01 |
Other NDCs under ANDA 204132
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 16.05 mg/mL | Solution/ dropsTransdermal | Proficient Rx LP | 63187-791 |
| Diclofenac Sodium | Diclofenac sodium 16.05 mg/mL | SolutionTopical | DIRECT RX | 72189-273 |
| Diclofenac Sodium | Diclofenac sodium 16.05 mg/mL | Solution/ dropsTransdermal | Asclemed USA, Inc. | 76420-134 |
| Diclofenac Sodium | Diclofenac sodium 16.05 mg/mL | SolutionTopical | Advanced Rx of Tennessee, LLC | 80425-0240 |
| Diclofenac Sodium 1.5%diclofenac sodium topical | Diclofenac sodium 16.05 mg/mL | SolutionTopical | Preferred Pharmaceuticals Inc. | 68788-8084 |
| Diclofenac Sodium 1.5%diclofenac sodium topical | Diclofenac sodium 16.05 mg/mL | SolutionTopical | Proficient Rx LP | 71205-640 |
| Diclofenac Sodium 1.5%diclofenac sodium topical | Diclofenac sodium 16.05 mg/mL | SolutionTopical | PHOENIX RX LLC | 85509-1038 |