Prescription drug · ANDA
Diclofenac Sodium NDC 83008-037
Diclofenac sodium 10 mg/g · Gel · Topical · Quality Care Products, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83008-037-00 | 83008003700 | 1 TUBE in 1 CARTON (83008-037-00) / 100 g in 1 TUBEMarketed from Aug 4, 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
- Generic name (nonproprietary)
- diclofenac sodium
- Active ingredients
- Diclofenac sodium — 10 mg/g
- Dosage form
- Gel
- Route
- Topical
- Labeler
- Quality Care Products, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209903
- Marketing start
- Marketing end
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)
- Identifiers
- Product ID 83008-037_b686004e-bfe6-4125-aea6-b94ed1eb700bSPL ID b686004e-bfe6-4125-aea6-b94ed1eb700bSPL set ID 12e1f808-9f24-4f6d-b5bc-12ce0059ab7aRxCUI 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
N483008003700followed by a unit qualifier and the quantityPackage 83008-0037-00. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
Diclofenac sodium is a non-steroidal anti-inflammatory drug indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands. ( 1 ) Diclofenac sodium topical gel was not evaluated for use on joints of the spine, hip, or shoulder. ( 14.1 ) Diclofenac sodium topical gel is indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands. Diclofenac sodium topical gel has not been evaluated for use on the spine, hip, or shoulder.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 209903
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 | EXELAN PHARMACEUTICALS INC. | 76282-103 |
| Diclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | Cipla USA Inc. | 69097-720 |
| Diclofenac Sodium | Diclofenac sodium 10 mg/g | GelTopical | NuCare Pharmaceuticals, Inc. | 68071-3665 |
| Diclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | NuCare Pharmaceuticals, Inc. | 68071-5307 |
| Diclofenac Sodium | Diclofenac sodium 10 mg/g | GelTopical | A-S Medication Solutions | 50090-4030 |
| Diclofenac Sodium | Diclofenac sodium 10 mg/g | GelTopical | A-S Medication Solutions | 50090-4020 |