Prescription drug · ANDA
Sulindac NDC 53489-479
Sulindac 200 mg/1 · Tablet · Oral · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 53489-479-01 | 53489047901 | 100 TABLET in 1 BOTTLE, PLASTIC (53489-479-01)Marketed from Sep 4, 2009 | |
| 53489-479-02 | 53489047902 | 50 TABLET in 1 BOTTLE, PLASTIC (53489-479-02)Marketed from Sep 4, 2009 | |
| 53489-479-03 | 53489047903 | 250 TABLET in 1 BOTTLE, PLASTIC (53489-479-03)Marketed from Sep 4, 2009 | |
| 53489-479-05 | 53489047905 | 500 TABLET in 1 BOTTLE, PLASTIC (53489-479-05)Marketed from Sep 4, 2009 | |
| 53489-479-06 | 53489047906 | 60 TABLET in 1 BOTTLE, PLASTIC (53489-479-06)Marketed from Sep 4, 2009 | |
| 53489-479-10 | 53489047910 | 1000 TABLET in 1 BOTTLE, PLASTIC (53489-479-10)Marketed from Sep 4, 2009 |
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
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 072051
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 53489-479_2524fd49-5789-e388-e063-6394a90a2c9bSPL ID 2524fd49-5789-e388-e063-6394a90a2c9bSPL set ID a47e4259-d44b-4b7b-b517-841cb6840982RxCUI 198238, 198239UNII 184SNS8VUHUPC 0353489479011, 0353489478014
- 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
N453489047901followed by a unit qualifier and the quantityPackage 53489-0479-01. 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 tablets and other treatment options before deciding to use sulindac tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Sulindac tablets 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
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 072051
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.