Prescription drug · ANDA
Sulfasalazine NDC 16571-261
Sulfasalazine 500 mg/1 · Tablet · Oral · Rising Pharma Holdings, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16571-261-01 | 16571026101 | 100 TABLET in 1 CONTAINER (16571-261-01)Marketed from Nov 4, 2025 | |
| 16571-261-30 | 16571026130 | 300 TABLET in 1 CONTAINER (16571-261-30)Marketed from Nov 4, 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
- Route
- Oral
- Labeler
- Rising Pharma Holdings, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 219046
- Marketing start
- Listing expires
- Other FDA classes
- Aminosalicylic Acids (Chemical structure)
- Identifiers
- Product ID 16571-261_4b43540c-2b08-44cb-81b8-4308dea2c141SPL ID 4b43540c-2b08-44cb-81b8-4308dea2c141SPL set ID 3254432e-87a4-4af0-afd1-d9e6f1b0efd4RxCUI 198232UNII 3XC8GUZ6CB
- 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
N416571026101followed by a unit qualifier and the quantityPackage 16571-0261-01. 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 tablets are indicated: a) in the treatment of mild to moderate ulcerative colitis, and as adjunctive therapy in severe ulcerative colitis; and b) for the prolongation of the remission period between acute attacks of ulcerative colitis.
Excerpt only. Read the full label for complete information.