Prescription drug · ANDA
Diclofenac Sodium Misoprostol (Diclofenac sodium and misoprostol) NDC 75834-265
Diclofenac sodium 75 mg/1; Misoprostol 200 ug/1 · Tablet, Delayed release · Oral · Nivagen Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 75834-265-60 | 7583402656075834026560 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (75834-265-60)Marketed from Jul 15, 2021 |
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 Misoprostol
- Generic name (nonproprietary)
- diclofenac sodium and misoprostol
- Active ingredients
- Diclofenac sodium — 75 mg/1Misoprostol — 200 ug/1
- Dosage form
- Tablet, Delayed release
- Route
- Oral
- Labeler
- Nivagen Pharmaceuticals, Inc.NDC labeler code 75834
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205143
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)Synthetic (Chemical structure)
- Identifiers
- Product ID 75834-265_542fd9dd-a6d3-4432-9e7a-2ca5bce12956SPL ID 542fd9dd-a6d3-4432-9e7a-2ca5bce12956SPL set ID 2acf46ac-8ba8-444d-b421-19d5ad49644cRxCUI 857706, 1359105UNII QTG126297Q, 0E43V0BB57UPC 0375834264608, 0375834265605
- Pharmacologic class
- Nonsteroidal Anti-inflammatory Drug; Prostaglandin E1 Analog
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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N475834026560followed by a unit qualifier and the quantityPackage 75834-0265-60. 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 and misoprostol delayed-release tablets are indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in adult patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications. For a list of factors that may increase the risk of NSAID-induced gastric and duodenal ulcers and their complications [see Warnings and Precautions (5.3) ] . Diclofenac sodium and misoprostol delayed-release tablets are a combination of diclofenac sodium, a non-steroidal anti-inflammatory drug, and misoprostol, a prostaglandin-1 (PGE1) analog, indicated for the treatment of signs and symptoms of osteoarthritis or rheumatoid arthri…
Excerpt only. Read the full label for complete information.
About NDC 75834-265
- What is NDC 75834-265?
- 75834-265 is the product NDC for Diclofenac Sodium Misoprostol, Diclofenac sodium 75 mg/1; Misoprostol 200 ug/1 tablet, delayed release, listed with the FDA by Nivagen Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Diclofenac Sodium Misoprostol (Diclofenac sodium and misoprostol).
- What is the active ingredient?
- Diclofenac sodium, Misoprostol.
- Who is the labeler?
- Nivagen Pharmaceuticals, Inc., NDC labeler code 75834. 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 Misoprostol?
- 6 other product NDCs are listed under this name. See all Diclofenac Sodium Misoprostol 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 Misoprostol 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 Sodium Misoprostoldiclofenac sodium and misoprostol | Diclofenac sodium 50 mg/1; Misoprostol 200 ug/1 | Tablet, Delayed releaseOral | Proficient Rx LP | 71205-865 | 71205-0865-0071205-0865-3071205-0865-55+4 more |
| Diclofenac Sodium Misoprostoldiclofenac sodium and misoprostol | Diclofenac sodium 75 mg/1; Misoprostol 200 ug/1 | Tablet, Delayed releaseOral | Proficient Rx LP | 71205-866 | 71205-0866-0071205-0866-3071205-0866-55+4 more |
| Diclofenac Sodium Misoprostoldiclofenac sodium and misoprostol | Diclofenac sodium 75 mg/1; Misoprostol 200 ug/1 | Tablet, Delayed releaseOral | Bryant Ranch Prepack | 71335-2441 | 71335-2441-0171335-2441-0271335-2441-03+2 more |
| Diclofenac Sodium Misoprostoldiclofenac sodium and misoprostol | Diclofenac sodium 50 mg/1; Misoprostol 200 ug/1 | Tablet, Delayed releaseOral | Bryant Ranch Prepack | 72162-2518 | 72162-2518-06 |
| Diclofenac Sodium Misoprostoldiclofenac sodium and misoprostol | Diclofenac sodium 75 mg/1; Misoprostol 200 ug/1 | Tablet, Delayed releaseOral | Bryant Ranch Prepack | 72162-2519 | 72162-2519-06 |
| Diclofenac Sodium Misoprostoldiclofenac sodium and misoprostol | Diclofenac sodium 50 mg/1; Misoprostol 200 ug/1 | Tablet, Delayed releaseOral | Nivagen Pharmaceuticals, Inc. | 75834-264 | 75834-0264-6075834-0264-90 |
Other NDCs under ANDA 205143
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 Misoprostoldiclofenac sodium and misoprostol | Diclofenac sodium 50 mg/1; Misoprostol 200 ug/1 | Tablet, Delayed releaseOral | Proficient Rx LP | 71205-865 |
| Diclofenac Sodium Misoprostoldiclofenac sodium and misoprostol | Diclofenac sodium 75 mg/1; Misoprostol 200 ug/1 | Tablet, Delayed releaseOral | Proficient Rx LP | 71205-866 |
| Diclofenac Sodium Misoprostoldiclofenac sodium and misoprostol | Diclofenac sodium 75 mg/1; Misoprostol 200 ug/1 | Tablet, Delayed releaseOral | Bryant Ranch Prepack | 71335-2441 |
| Diclofenac Sodium Misoprostoldiclofenac sodium and misoprostol | Diclofenac sodium 50 mg/1; Misoprostol 200 ug/1 | Tablet, Delayed releaseOral | Bryant Ranch Prepack | 72162-2518 |
| Diclofenac Sodium Misoprostoldiclofenac sodium and misoprostol | Diclofenac sodium 75 mg/1; Misoprostol 200 ug/1 | Tablet, Delayed releaseOral | Bryant Ranch Prepack | 72162-2519 |
| Diclofenac Sodium Misoprostoldiclofenac sodium and misoprostol | Diclofenac sodium 50 mg/1; Misoprostol 200 ug/1 | Tablet, Delayed releaseOral | Nivagen Pharmaceuticals, Inc. | 75834-264 |