Prescription drug · ANDA
Sulindac NDC 55289-930
Sulindac 200 mg/1 · Tablet · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55289-930-10 | 55289093010 | 10 TABLET in 1 BOTTLE, PLASTIC (55289-930-10)Marketed from Jul 12, 2010 | |
| 55289-930-20 | 55289093020 | 20 TABLET in 1 BOTTLE, PLASTIC (55289-930-20)Marketed from Jul 12, 2010 | |
| 55289-930-30 | 55289093030 | 30 TABLET in 1 BOTTLE, PLASTIC (55289-930-30)Marketed from Jul 12, 2010 |
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)
- Sulindac
- Generic name (nonproprietary)
- sulindac
- Active ingredients
- Sulindac — 200 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 071795
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 55289-930_30ca698c-7fb2-9fa7-e063-6294a90abd86SPL ID 30ca698c-7fb2-9fa7-e063-6294a90abd86SPL set ID 68d4eeed-2501-494b-b979-502720de86c0RxCUI 198239UNII 184SNS8VUHUPC 0355289930105
- 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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N455289093010followed by a unit qualifier and the quantityPackage 55289-0930-10. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE Carefully consider the potential benefits and risks of sulindac and other treatment options before deciding to use sulindac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Sulindac tablets, USP are indicated for acute or long-term use in the relief of signs and symptoms of the following: Osteoarthritis Rheumatoid arthritis** Ankylosing spondylitis Acute painful shoulder (Acute subacromial bursitis/supraspinatus tendinitis) Acute gouty arthritis **The safety and effectiveness of sulindac have not been established in rheumatoid arthritis patients who are designated in the American Rheumatism Asso…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 071795
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 |
|---|---|---|---|---|
| Sulindac | Sulindac 200 mg/1 | TabletOral | Actavis Pharma, Inc. | 0591-5660 |