Over-the-counter drug · ANDA
Diclofenac Sodium Topical 1% (Diclofenac sodium) NDC 73581-104
Diclofenac sodium 1 mg/100g · Gel · Topical · YYBA CORP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 73581-104-10 | 7358101041073581010410 | 1 TUBE in 1 BOX (73581-104-10) / 100 g in 1 TUBEMarketed from Aug 31, 2023 | |
| 73581-104-15 | 7358101041573581010415 | 1 TUBE in 1 BOX (73581-104-15) / 150 g in 1 TUBEMarketed from Aug 31, 2023 |
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 Topical 1%Suffix: 1%
- Generic name (nonproprietary)
- diclofenac sodium
- Active ingredients
- Diclofenac sodium — 1 mg/100g
- Dosage form
- Gel
- Route
- Topical
- Labeler
- YYBA CORPNDC labeler code 73581
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210986
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)
- Identifiers
- Product ID 73581-104_43412567-2420-f159-e063-6394a90a2d87SPL ID 43412567-2420-f159-e063-6394a90a2d87SPL set ID 043df5d2-6f3e-311f-e063-6294a90a23d7RxCUI 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
N473581010410followed by a unit qualifier and the quantityPackage 73581-0104-10. 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, KNEWW (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 IN 7 DAYS, STOP USE.
Excerpt only. Read the full label for complete information.
About NDC 73581-104
- What is NDC 73581-104?
- 73581-104 is the product NDC for Diclofenac Sodium Topical 1% (diclofenac sodium), Diclofenac sodium 1 mg/100g gel, listed with the FDA by YYBA CORP. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Diclofenac Sodium Topical 1% (Diclofenac Sodium).
- What is the active ingredient?
- Diclofenac sodium.
- Who is the labeler?
- YYBA CORP, NDC labeler code 73581. 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 Topical 1%?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under ANDA 210986
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 |
|---|---|---|---|---|
| Arthritis Paindiclofenac sodium topical gel, 1% | Diclofenac sodium 10 mg/g | GelTopical | Discount Drug Mart, Inc. | 53943-523 |
| Arthritis Paindiclofenac sodium topical gel, 1% | Diclofenac sodium 10 mg/g | GelTopical | Strategic Sourcing Services, LLC | 70677-1125 |
| Aspercreme Arthritisdiclofenac sodium | Diclofenac sodium .01 g/g | GelTopical | Chattem, Inc. | 41167-0571 |
| Crcle Diclofenac Sodium Topical Gel 1%diclofenac sodium topical gel 1% | Diclofenac sodium 10 mg/g | GelTopical | Innovus Pharmaceuticals Inc. | 57483-596 |
| Curist Arthritis Reliefdiclofenac sodium | Diclofenac sodium 1 g/100g | GelTopical | Little Pharma, Inc. | 72559-020 |
| Diclofenac Sodiumdiclofenac sodium topical gel, 1% | Diclofenac sodium 10 mg/g | GelTopical | Encube Ethicals, Inc. | 21922-044 |
| Diclofenac Sodiumdiclofenac sodium topical gel, 1% | Diclofenac sodium 10 mg/g | GelTopical | Dr. Reddy's Laboratories Inc. | 43598-885 |
| Diclofenac Sodiumdiclofenac sodium topical gel, 1% | Diclofenac sodium 10 mg/g | GelTopical | Dr. Reddy's Laboratories Inc. | 43598-977 |
| Diclofenac Sodiumdiclofenac sodium topical gel, 1%, | Diclofenac sodium 10 mg/g | GelTopical | A-S Medication Solutions | 50090-6998 |
| Diclofenac Sodiumdiclofenac sodium topical gel, 1%, | Diclofenac sodium 10 mg/g | GelTopical | A-S Medication Solutions | 50090-7243 |
| Diclofenac Sodiumdiclofenac sodium topical gel, 1% | Diclofenac sodium 10 mg/g | GelTopical | GERI-CARE PHARMACEUTICALS CORP | 57896-140 |
| Diclofenac Sodiumdiclofenac sodium topical gel, 1% | Diclofenac sodium 10 mg/g | GelTopical | Simple Diagnostics | 62379-401 |
| Diclofenac Sodiumdiclofenac sodium topical gel, 1% | Diclofenac sodium 10 mg/g | GelTopical | Chain Drug Marketing Association INC | 63868-730 |
| Diclofenac Sodiumdiclofenac sodium topical gel, 1% | Diclofenac sodium 10 mg/g | GelTopical | BluePoint Laboratories | 68001-621 |
| Diclofenac Sodium | Diclofenac sodium 10 mg/g | GelTopical | NuCare Pharmaceuticals,Inc. | 68071-2239 |
| Diclofenac Sodiumdiclofenac sodium topical gel, 1% | Diclofenac sodium 10 mg/g | GelTopical | NuCare Pharmaceuticals,Inc. | 68071-3483 |
| Diclofenac Sodiumdiclofenac sodium topical gel, 1%, | Diclofenac sodium 10 mg/g | GelTopical | Preferred Pharmaceuticals, Inc. | 68788-7772 |
| Diclofenac Sodiumdiclofenac sodium 1% | Diclofenac sodium 10 mg/g | GelTopical | SOLA Pharmaceuticals | 70512-106 |
| Diclofenac Sodiumdiclofenac sodium topical gel, 1% | Diclofenac sodium 10 mg/g | GelTopical | IPG Pharmaceuticals, inc. | 71085-084 |
| Diclofenac Sodiumdiclofenac sodium topical gel, 1%, | Diclofenac sodium 10 mg/g | GelTopical | Proficient Rx LP | 71205-552 |
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