Prescription drug · ANDA
Diclofenac Sodium Gel NDC 72189-379
Diclofenac sodium 30 mg/g · Gel · Topical · Direct_Rx
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72189-379-01 | 72189037901 | 1 g in 1 TUBE (72189-379-01)Marketed from Sep 8, 2022 |
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 Gel
- Generic name (nonproprietary)
- diclofenac sodium gel
- Active ingredients
- Diclofenac sodium — 30 mg/g
- Dosage form
- Gel
- Route
- Topical
- Labeler
- Direct_RxNDC labeler code 72189
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208301
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)
- Identifiers
- Product ID 72189-379_4d3a653e-054e-4554-e063-6294a90a1239SPL ID 4d3a653e-054e-4554-e063-6294a90a1239SPL set ID e82e4d34-bdaa-b950-e053-2995a90a29f1RxCUI 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
N472189037901followed by a unit qualifier and the quantityPackage 72189-0379-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
Diclofenac sodium gel is indicated for the topical treatment of actinic keratoses (AK).
Excerpt only. Read the full label for complete information.
About NDC 72189-379
- What is NDC 72189-379?
- 72189-379 is the product NDC for Diclofenac Sodium Gel, Diclofenac sodium 30 mg/g gel, 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 Gel.
- 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 Gel?
- 2 other product NDCs are listed under this name. See all Diclofenac Sodium Gel 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 Gel 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 Gel | Diclofenac sodium 10 mg/g | GelTopical | Direct_Rx | 72189-479 | 72189-0479-01 |
| Diclofenac Sodium Gel | Diclofenac sodium 30 mg/g | GelTopical | Direct_Rx | 72189-473 | 72189-0473-01 |
Other NDCs under ANDA 208301
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 30 mg/g | GelTopical | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0236 |
| Diclofenac Sodium | Diclofenac sodium 30 mg/g | GelTopical | HAWAII REPACK, INC | 85534-0089 |
| Diclofenac Sodium | Diclofenac sodium 30 mg/g | GelTopical | REMEDYREPACK INC. | 70518-3315 |
| Diclofenac Sodium | Diclofenac sodium 30 mg/g | GelTopical | Preferred Pharmaceuticals Inc. | 68788-9435 |
| Diclofenac Sodium | Diclofenac sodium 30 mg/g | GelTopical | Proficient Rx LP | 82804-052 |
| Diclofenac Sodium | Diclofenac sodium 30 mg/g | GelTopical | NuCare Pharmaceuticals,Inc. | 68071-3516 |
| Diclofenac Sodium | Diclofenac sodium 30 mg/g | GelTopical | GLENMARK PHARMACEUTICALS INC., USA | 68462-355 |
| Diclofenac Sodium | Diclofenac sodium 30 mg/g | GelTopical | Asclemed USA, Inc. | 76420-132 |