Over-the-counter drug · ANDA
Diclofenac Sodium NDC 45802-953
Diclofenac sodium 10 mg/g · Gel · Topical · Padagis Israel Pharmaceuticals Ltd
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 45802-953-01 | 4580209530145802095301 | 1 TUBE in 1 CARTON (45802-953-01) / 100 g in 1 TUBEMarketed from Jul 9, 2020 |
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
- Generic name (nonproprietary)
- diclofenac sodium
- Active ingredients
- Diclofenac sodium — 10 mg/g
- Dosage form
- Gel
- Route
- Topical
- Labeler
- Padagis Israel Pharmaceuticals LtdNDC labeler code 45802
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211253
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)
- Identifiers
- Product ID 45802-953_2672b394-97f0-4839-add5-176504b9de00SPL ID 2672b394-97f0-4839-add5-176504b9de00SPL set ID 17bd62a8-b697-48cc-b988-aac3c19c6dc5RxCUI 855633UNII 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
N445802095301followed by a unit qualifier and the quantityPackage 45802-0953-01. 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)
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.
About NDC 45802-953
- What is NDC 45802-953?
- 45802-953 is the product NDC for Diclofenac Sodium, Diclofenac sodium 10 mg/g gel, listed with the FDA by Padagis Israel Pharmaceuticals Ltd. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Diclofenac Sodium.
- What is the active ingredient?
- Diclofenac sodium.
- Who is the labeler?
- Padagis Israel Pharmaceuticals Ltd, NDC labeler code 45802. 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 211253
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 |
|---|---|---|---|---|
| good sense arthritis paindiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | A-S Medication Solutions | 50090-7250 |
| arthritis pain relievingdiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | Walgreen Company | 0363-5123 |
| arthritis pain relievingdiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | Meijer Distribution Inc | 41250-674 |
| Motrin Arthritis Paindiclofenac sodium | Diclofenac sodium 9.3 mg/g | GelTopical | Kenvue Brands LLC | 50580-574 |
| Diclofenac Sodium | Diclofenac sodium 10 mg/g | GelTopical | NuCare Pharmaceuticals,Inc. | 68071-3456 |
| Arthritis Pain Relieverdiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | Publix Super Markets Inc | 56062-471 |
| Equate Arthritis Paindiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | WALMART INC. | 79903-391 |
| Arthritis Pain Reliefdiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 51316-517 |
| topcare athritis pain relieverdiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | Topco Associates LLC | 36800-526 |
| CareOne arthritis pain reliefdiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | American Sales Company | 41520-788 |
| arthritis pain relieverdiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | Publix Super Markets Inc | 56062-878 |
| Aspercreme Arthritisdiclofenac sodium | Diclofenac sodium .01 g/g | GelTopical | Chattem, Inc. | 41167-0573 |
| Arthritis Pain Relievingdiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | Walgreen Company | 0363-3003 |
| Diclofenac Sodium | Diclofenac sodium 10 mg/g | GelTopical | CVS Pharmacy | 69842-729 |
| good sense arthritis paindiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | L. Perrigo Company | 0113-1189 |
| basic care arthritis paindiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | Amazon.com Services LLC | 72288-870 |
| berkley and jensen arthritis paindiclofenac sodium | — | Kit | BJWC | 68391-205 |
| Members Mark Arthritis Pain Relieverdiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | Sam's West Inc | 68196-523 |
| Dg Health Arthritis Paindiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | Dolgencorp Inc | 55910-926 |
| members mark arthritis pain relieverdiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | Sam's West Inc | 68196-870 |
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