Over-the-counter drug · ANDA
diclofenac sodium NDC 68071-3671
Diclofenac sodium 10 mg/g · Gel · Topical · NuCare Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68071-3671-1 | 6807136710168071367101 | 1 TUBE in 1 CARTON (68071-3671-1) / 100 g in 1 TUBEMarketed from Aug 30, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- NuCare Pharmaceuticals, Inc.NDC labeler code 68071
- 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 68071-3671_20ef1493-6f0e-b4fc-e063-6394a90a888bSPL ID 20ef1493-6f0e-b4fc-e063-6394a90a888bSPL set ID 20ef08a3-35cf-b4d6-e063-6394a90a012eRxCUI 855633UNII QTG126297QUPC 0368071367119
- 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
N468071367101followed by a unit qualifier and the quantityPackage 68071-3671-01. 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 68071-3671
- What is NDC 68071-3671?
- 68071-3671 is the product NDC for diclofenac sodium, Diclofenac sodium 10 mg/g gel, listed with the FDA by NuCare Pharmaceuticals, Inc.. 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?
- NuCare Pharmaceuticals, Inc., NDC labeler code 68071. 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 |
|---|---|---|---|---|
| Dg Health Arthritis Paindiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | Dolgencorp Inc | 55910-926 |
| Diclofenac Sodium | Diclofenac sodium 10 mg/g | GelTopical | CVS Pharmacy | 69842-729 |
| berkley and jensen arthritis paindiclofenac sodium | — | Kit | BJWC | 68391-205 |
| Up And Up Arthritis Pain Relieverdiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | Target Corporation | 82442-251 |
| basic care arthritis paindiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | Amazon.com Services LLC | 72288-870 |
| Arthritis Pain Relievingdiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | Meijer, Inc. | 79481-0499 |
| Members Mark Arthritis Pain Relieverdiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | Sam's West Inc | 68196-523 |
| members mark arthritis pain relieverdiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | Sam's West Inc | 68196-870 |
| DG health arthritis paindiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | Dolgencorp Inc | 55910-424 |
| up and up arthritis pain relieverdiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | Target Corporation | 11673-569 |
| kirkland signature arthritis pain reliefdiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | Costco Wholesale Company | 63981-599 |
| kirkland signature arthritis pain reliefdiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | Costco Wholesale Company | 63981-799 |
| Foster And Thrive Arthritis Paindiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | Strategic Sourcing Services LLC | 70677-1293 |
| Diclofenac Sodium Topicaldiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 51316-804 |
| Aleve Arthritis Pain Geldiclofenac sodium | Diclofenac sodium 1 mg/g | GelTopical | Bayer HealthCare LLC | 0280-0039 |
| Good Sense Arthritis Paindiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | L. Perrigo Company | 0113-8175 |
| Diclofenac Sodium | Diclofenac sodium 10 mg/g | GelTopical | Rite Aid Corporation | 11822-0870 |
| arthritis pain relieverdiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | H E B | 37808-087 |
| Arthritis Pain Relieverdiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | H E B | 59640-198 |
| arthritis pain relieverdiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | HyVee Inc | 42507-150 |
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