Prescription drug · NDA
Azulfidine (sulfasalazine) NDC 0013-0101
Sulfasalazine 500 mg/1 · Tablet · Oral · Pfizer Laboratories Div Pfizer Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0013-0101-10 | 00013010110 | 1 BOTTLE in 1 CARTON (0013-0101-10) / 100 TABLET in 1 BOTTLEMarketed from Feb 27, 2020 | |
| 0013-0101-30 | 00013010130 | 1 BOTTLE in 1 CARTON (0013-0101-30) / 300 TABLET in 1 BOTTLEMarketed from Feb 27, 2020 |
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
- Generic name (nonproprietary)
- sulfasalazine
- Active ingredients
- Sulfasalazine — 500 mg/1
- Dosage form
- Tablet
- 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 0013-0101_8d2e14e3-000c-41bb-82d4-c9a67330e0d9SPL ID 8d2e14e3-000c-41bb-82d4-c9a67330e0d9SPL set ID ddbe69f3-bd55-45f3-a64f-f60226c744c4RxCUI 198232, 208437UNII 3XC8GUZ6CBUPC 0300130101012
- 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
N400013010110followed by a unit qualifier and the quantityPackage 00013-0101-10. 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 Tablets are indicated: • in the treatment of mild to moderate ulcerative colitis, and as adjunctive therapy in severe ulcerative colitis; and • 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 |
|---|---|---|---|---|
| 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 | 50090-0086 |
| 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 |