Prescription drug · NDA
Azulfidine EN-tabs (sulfasalazine) NDC 0013-0102
Sulfasalazine 500 mg/1 · Tablet, Delayed release · Oral · Pfizer Laboratories Div Pfizer Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0013-0102-50 | 00013010250 | 1 BOTTLE in 1 CARTON (0013-0102-50) / 100 TABLET, DELAYED RELEASE in 1 BOTTLEMarketed from Jul 7, 2020 | |
| 0013-0102-60 | 00013010260 | 1 BOTTLE in 1 CARTON (0013-0102-60) / 300 TABLET, DELAYED RELEASE in 1 BOTTLEMarketed from Feb 15, 2021 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Azulfidine EN-tabsSuffix: EN-tabs
- Generic name (nonproprietary)
- sulfasalazine
- Active ingredients
- Sulfasalazine — 500 mg/1
- Dosage form
- Tablet, Delayed release
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 007073
- Marketing start
- Listing expires
- Other FDA classes
- Aminosalicylic Acids (Chemical structure)
- Identifiers
- Product ID 0013-0102_f4631374-60aa-4e49-ac58-632f9cbdea08SPL ID f4631374-60aa-4e49-ac58-632f9cbdea08SPL set ID b9ef541a-93c8-4428-ba45-398aa0b327d1RxCUI 313142, 724154UNII 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
N400013010250followed by a unit qualifier and the quantityPackage 00013-0102-50. 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 AZULFIDINE EN-tabs 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 responded …
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 |
| Sulfasalazine | Sulfasalazine 500 mg/1 | Tablet, Delayed releaseOral | Mylan Pharmaceuticals Inc. | 59762-0104 |
| 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 |