Prescription drug · ANDA
Sulfasalazine NDC 11534-201
Sulfasalazine 500 mg/1 · Tablet, Delayed release · Oral · Sunrise Pharmaceutical, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 11534-201-01 | 11534020101 | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (11534-201-01)Marketed from Dec 11, 2025 | |
| 11534-201-07 | 11534020107 | 300 TABLET, DELAYED RELEASE in 1 BOTTLE (11534-201-07)Marketed from Dec 11, 2025 |
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)
- Sulfasalazine
- Generic name (nonproprietary)
- sulfasalazine
- Active ingredients
- Sulfasalazine — 500 mg/1
- Dosage form
- Tablet, Delayed release
- Route
- Oral
- Labeler
- Sunrise Pharmaceutical, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075339
- Marketing start
- Listing expires
- Other FDA classes
- Aminosalicylic Acids (Chemical structure)
- Identifiers
- Product ID 11534-201_86d69175-60ab-4573-9c76-b995fc3a7802SPL ID 86d69175-60ab-4573-9c76-b995fc3a7802SPL set ID d596ac59-b643-4181-80ba-f2db1cc3459cRxCUI 313142UNII 3XC8GUZ6CBUPC 0311534201017, 0311534201079
- Pharmacologic class
- Aminosalicylate
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
N411534020101followed by a unit qualifier and the quantityPackage 11534-0201-01. 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 .
Indications (excerpt from the label)
INDICATIONS AND USAGE SULFASALAZINE DELAYED RELEASE Tablets, USP are indicated: a)in the treatment of mild to moderate ulcerative colitis, and as adjunctive therapy in severe ulcerative colitis;b)for the prolongation of the remission period between acute attacks of ulcerative colitis;c)in the treatment of patients with rheumatoid arthritis who have responded inadequately to salicylates or other nonsteroidal anti-inflammatory drugs (e.g., an insufficient therapeutic response to, or intolerance of, an adequate trial of full doses of one or more nonsteroidal anti-inflammatory drugs); andd)in the treatment of pediatric patients with polyarticular-course 1 juvenile rheumatoid arthritis who have r…
Excerpt only. Read the full label for complete information.