Prescription drug · ANDA
Diclofenac Sodium Topical Solution NDC 72189-575
Diclofenac sodium 20 mg/g · Solution · Topical · Direct_Rx
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72189-575-04 | 7218905750472189057504 | 112 g in 1 BOTTLE, PUMP (72189-575-04)Marketed from Sep 16, 2024 |
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 Topical Solution
- Generic name (nonproprietary)
- diclofenac sodium topical solution
- Active ingredients
- Diclofenac sodium — 20 mg/g
- Dosage form
- Solution
- Route
- Topical
- Labeler
- Direct_RxNDC labeler code 72189
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208021
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)
- Identifiers
- Product ID 72189-575_4d3a452b-bb60-24a6-e063-6294a90a6d21SPL ID 4d3a452b-bb60-24a6-e063-6294a90a6d21SPL set ID 223f0fb4-2006-c2dd-e063-6394a90a563aRxCUI 1487074UNII 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
N472189057504followed by a unit qualifier and the quantityPackage 72189-0575-04. 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 solution is indicated for the treatment of the pain of osteoarthritis of the knee(s).
Excerpt only. Read the full label for complete information.
About NDC 72189-575
- What is NDC 72189-575?
- 72189-575 is the product NDC for Diclofenac Sodium Topical Solution, Diclofenac sodium 20 mg/g solution, listed with the FDA by Direct_Rx. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Diclofenac Sodium Topical Solution.
- What is the active ingredient?
- Diclofenac sodium.
- Who is the labeler?
- Direct_Rx, NDC labeler code 72189. 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 Topical Solution?
- 1 other product NDC are listed under this name. See all Diclofenac Sodium Topical Solution 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 Topical Solution 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 Topical Solution | Diclofenac sodium 20 mg/g | SolutionTopical | Direct_Rx | 72189-546 | 72189-0546-04 |
Other NDCs under ANDA 208021
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 20 mg/g | SolutionTopical | Lupin Pharmaceuticals, Inc. | 68180-537 |
| Diclofenac Sodium | Diclofenac sodium 20 mg/g | SolutionTopical | Preferred Pharmaceuticals Inc. | 68788-8743 |
| Diclofenac Sodium | Diclofenac sodium 20 mg/g | SolutionTopical | Advanced Rx of Tennessee, LLC | 80425-0405 |
| Diclofenac Sodium | Diclofenac sodium 20 mg/g | SolutionTopical | Proficient Rx LP | 82804-113 |
| Diclofenac Sodium | Diclofenac sodium 20 mg/g | SolutionTopical | PHOENIX RX LLC | 85509-1537 |
| Diclofenac Sodium | Diclofenac sodium 20 mg/g | SolutionTopical | ASCLEMED USA INC. | 87063-223 |