Over-the-counter drug · ANDA
Diclofenac sodium NDC 0536-1294
Diclofenac sodium 10 mg/g · Gel · Topical · Rugby Laboratories
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0536-1294-31 | 00536129431 | 1 TUBE in 1 CARTON (0536-1294-31) / 150 g in 1 TUBEMarketed from Sep 14, 2020 | |
| 0536-1294-34 | 00536129434 | 1 TUBE in 1 CARTON (0536-1294-34) / 50 g in 1 TUBEMarketed from Sep 14, 2020 | |
| 0536-1294-97 | 00536129497 | 1 TUBE in 1 CARTON (0536-1294-97) / 100 g in 1 TUBEMarketed from Sep 14, 2020 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- Generic name (nonproprietary)
- diclofenac sodium
- Active ingredients
- Diclofenac sodium — 10 mg/g
- Dosage form
- Gel
- Route
- Topical
- Labeler
- Rugby Laboratories
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208077
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)
- Identifiers
- Product ID 0536-1294_8b734e52-fc53-489b-97a3-bea23f008d40SPL ID 8b734e52-fc53-489b-97a3-bea23f008d40SPL set ID 95f3c70c-eded-4d24-b9b0-cfa0b7902d6eRxCUI 855633UNII QTG126297QUPC 0305361294977
- 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
N400536129431followed by a unit qualifier and the quantityPackage 00536-1294-31. 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)
Uses for the temporary relief of arthritis pain ONLY in the following areas: hand, wrist, elbow (upper body areas) foot, ankle, knee (lower body areas) this product may take up to 7 days to work for arthritis pain; it is not for immediate relief. If no pain relief in 7 days, stop use.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 208077
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 10 mg/g | GelTopical | Costco Wholesale | 63981-112 |
| Arthritis Pain Relieverdiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | Chain Drug Consortium, LLC | 68016-171 |
| Arthritis Pain Relieverdiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | AmerisourceBergen (Good Neighbor Pharmacy) 46122 | 46122-752 |
| Diclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | CARDINAL HEALTH 110, LLC. DBA LEADER 70000 | 70000-0555 |
| Diclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | Costco Wholesale | 63981-211 |
| Arthritis Pain Relieverdiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | Family Dollar (FAMILY WELLNESS) | 55319-969 |
| Arthritis Pain Relieverdiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | QUALITY CHOICE (Chain Drug Marketing Association) | 83324-306 |
| Diclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | Safeway, Inc. | 21130-028 |
| Salonpasdiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | Hisamitsu America, Inc. | 55328-801 |
| Diclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | CVS Pharmacy | 69842-974 |
| Arthritis Pain Relieverdiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | P & L Development, LLC | 59726-012 |
| Arthritis Pain Relieverdiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | CVS PHARMACY, INC | 51316-012 |
| Diclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | 49035-269 |
| Diclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | Sportpharm LLC | 85766-136 |
| Diclofenac sodiumdiclofenac | Diclofenac sodium 10 mg/g | GelTopical | Amneal Pharmaceuticals NY LLC | 69238-2053 |
| Arthritis Pain Relieverdiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | CVS PHARMACY, INC | 51316-073 |
| Diclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | Walgreens | 0363-1210 |
| Diclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | Best Choice (Valu Merchandisers Company) | 63941-812 |
| Diclofenac sodiumdiclofenac | Diclofenac sodium 10 mg/g | GelTopical | Scholl's Wellness Company | 73469-2053 |