Over-the-counter drug · ANDA
Arthritis Pain Reliever (Diclofenac sodium) NDC 68016-171
Diclofenac sodium 10 mg/g · Gel · Topical · Chain Drug Consortium, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68016-171-00 | 6801601710068016017100 | 1 TUBE in 1 CARTON (68016-171-00) / 100 g in 1 TUBEMarketed from Dec 31, 2022 | |
| 68016-171-50 | 6801601715068016017150 | 1 TUBE in 1 CARTON (68016-171-50) / 50 g in 1 TUBEMarketed from Dec 31, 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)
- Arthritis Pain Reliever
- Generic name (nonproprietary)
- diclofenac sodium
- Active ingredients
- Diclofenac sodium — 10 mg/g
- Dosage form
- Gel
- Route
- Topical
- Labeler
- Chain Drug Consortium, LLCNDC labeler code 68016
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208077
- Marketing start
- Marketing end
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)
- Identifiers
- Product ID 68016-171_f872b707-a589-455f-a4bf-4c0bb637ded9SPL ID f872b707-a589-455f-a4bf-4c0bb637ded9SPL set ID 8879a2ed-6c66-4489-8adc-9f160241cc7dRxCUI 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
N468016017100followed by a unit qualifier and the quantityPackage 68016-0171-00. 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 68016-171
- What is NDC 68016-171?
- 68016-171 is the product NDC for Arthritis Pain Reliever (diclofenac sodium), Diclofenac sodium 10 mg/g gel, listed with the FDA by Chain Drug Consortium, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Arthritis Pain Reliever (Diclofenac sodium).
- What is the active ingredient?
- Diclofenac sodium.
- Who is the labeler?
- Chain Drug Consortium, LLC, NDC labeler code 68016. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Arthritis Pain Reliever?
- 13 other product NDCs are listed under this name. See all Arthritis Pain Reliever NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Arthritis Pain Reliever products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| arthritis pain relieverdiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | HyVee Inc | 42507-150 | 42507-0150-01 |
| Arthritis Pain Relieverdiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | Publix Super Markets Inc | 56062-471 | 56062-0471-02 |
| Arthritis Pain Relieverdiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | H E B | 59640-198 | 59640-0198-0159640-0198-0259640-0198-03 |
| Arthritis Pain Relieverdiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | QUALITY CHOICE (Chain Drug Marketing Association) | 83324-306 | 83324-0306-01 |
| Arthritis Pain Relieverdiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | Family Dollar (FAMILY WELLNESS) | 55319-969 | 55319-0969-17 |
| Arthritis Pain Relieverdiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | AmerisourceBergen (Good Neighbor Pharmacy) 46122 | 46122-752 | 46122-0752-3746122-0752-5246122-0752-53 |
| Arthritis Pain Relieveracetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | WALGREENS | 0363-9781 | 00363-9781-0100363-9781-42 |
| Arthritis Pain Relieverdiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | CVS PHARMACY, INC | 51316-012 | 51316-0012-15 |
| Arthritis Pain Relieverdiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | CVS PHARMACY, INC | 51316-073 | 51316-0073-76 |
| Arthritis Pain Relieverdiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | P & L Development, LLC | 59726-012 | 59726-0012-5059726-0012-53 |
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 sodiumdiclofenac | Diclofenac sodium 10 mg/g | GelTopical | Amneal Pharmaceuticals NY LLC | 69238-2053 |
| 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 | AmerisourceBergen (Good Neighbor Pharmacy) 46122 | 46122-752 |
| Diclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | Sportpharm LLC | 85766-136 |
| Arthritis Pain Relieverdiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | CVS PHARMACY, INC | 51316-073 |
| Diclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | Best Choice (Valu Merchandisers Company) | 63941-812 |
| Diclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | Safeway, Inc. | 21130-028 |
| Arthritis Pain Relieverdiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | QUALITY CHOICE (Chain Drug Marketing Association) | 83324-306 |
| Arthritis Pain Relieverdiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | CVS PHARMACY, INC | 51316-012 |
| Diclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | Walgreens | 0363-1210 |
| Diclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | Costco Wholesale | 63981-211 |
| 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 | Rugby Laboratories | 0536-1294 |
| Diclofenac sodiumdiclofenac | Diclofenac sodium 10 mg/g | GelTopical | Scholl's Wellness Company | 73469-2053 |
| Arthritis Pain Relieverdiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | Family Dollar (FAMILY WELLNESS) | 55319-969 |
| Diclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | CVS Pharmacy | 69842-974 |
| Diclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | 49035-269 |
| Salonpasdiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | Hisamitsu America, Inc. | 55328-801 |