Prescription drug · NDA AUTHORIZED GENERIC
Sulfasalazine NDC 50090-0086
Sulfasalazine 500 mg/1 · Tablet · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-0086-4 | 50090008604 | 90 TABLET in 1 BOTTLE (50090-0086-4)Marketed from Nov 10, 2021 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- A-S Medication Solutions
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 007073
- Marketing start
- Listing expires
- Other FDA classes
- Aminosalicylic Acids (Chemical structure)
- Identifiers
- Product ID 50090-0086_48066ade-48d8-492d-b0b6-9aafad705a5bSPL ID 48066ade-48d8-492d-b0b6-9aafad705a5bSPL set ID 32fd1726-ed81-4441-9594-3aecf2db1dbfRxCUI 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
N450090008604followed by a unit qualifier and the quantityPackage 50090-0086-04. 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.
Other NDCs under NDA 007073
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 |
|---|---|---|---|---|
| Azulfidinesulfasalazine | Sulfasalazine 500 mg/1 | TabletOral | Pfizer Laboratories Div Pfizer Inc | 0013-0101 |
| Sulfasalazine | Sulfasalazine 500 mg/1 | TabletOral | Mylan Pharmaceuticals Inc. | 59762-5000 |
| Sulfasalazine | Sulfasalazine 500 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-1829 |
| Azulfidine EN-tabssulfasalazine | Sulfasalazine 500 mg/1 | Tablet, Delayed releaseOral | Pfizer Laboratories Div Pfizer Inc | 0013-0102 |
| Sulfasalazine | Sulfasalazine 500 mg/1 | Tablet, Delayed releaseOral | Mylan Pharmaceuticals Inc. | 59762-0104 |
| Sulfasalazine | Sulfasalazine 500 mg/1 | TabletOral | A-S Medication Solutions | 50090-6936 |
| Sulfasalazine | Sulfasalazine 500 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-706 |