Prescription drug · NDA AUTHORIZED GENERIC
Sulfasalazine NDC 59762-0104
Sulfasalazine 500 mg/1 · Tablet, Delayed release · Oral · Mylan Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59762-0104-5 | 59762010405 | 1 BOTTLE in 1 CARTON (59762-0104-5) / 100 TABLET, DELAYED RELEASE in 1 BOTTLEMarketed from Mar 23, 2020 | |
| 59762-0104-6 | 59762010406 | 1 BOTTLE in 1 CARTON (59762-0104-6) / 300 TABLET, DELAYED RELEASE in 1 BOTTLEMarketed from Apr 6, 2020 |
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, Delayed release
- Route
- Oral
- Labeler
- Mylan Pharmaceuticals Inc.
- 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 59762-0104_0e53b1e5-3efe-4e5a-8d20-108f96490393SPL ID 0e53b1e5-3efe-4e5a-8d20-108f96490393SPL set ID 257cee60-b68f-4c2b-b57d-8e4d73d17e09RxCUI 313142UNII 3XC8GUZ6CBUPC 0359762010414
- 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
N459762010405followed by a unit qualifier and the quantityPackage 59762-0104-05. 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 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); and d) in the treatment of pediatric patients with polyarticular-course 1 juvenile rheumatoid arthritis who have…
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 | TabletOral | A-S Medication Solutions | 50090-0086 |
| 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 |