Sulfasalazine
- Product NDC
- 11534-201
- 11-digit product format
- 115340201
- Labeler code
- 11534
- Product ID
- 11534-201_86d69175-60ab-4573-9c76-b995fc3a7802
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sulfasalazine
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Sunrise Pharmaceutical, Inc.
- Application
- ANDA075339
- Marketing category
- ANDA
- Marketing start
- 2025-12-11
- Substance
- SULFASALAZINE
- Active strength
- 500 mg/1
- Pharmacologic classes
- Aminosalicylate [EPC], Aminosalicylic Acids [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Sulfasalazine
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SULFASALAZINE | 500 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3XC8GUZ6CB |
| Rxcui | 313142 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 11534-201-01 | Sulfasalazine | 100 in 1 BOTTLE | TABLET, DELAYED RELEASE | 100 | | 4 |
| 11534-201-07 | Sulfasalazine | 300 in 1 BOTTLE | TABLET, DELAYED RELEASE | 300 | | 4 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 11534-201-01 | 11534020101 | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (11534-201-01) | 2025-12-11 | No | No | Current |
| 11534-201-07 | 11534020107 | 300 TABLET, DELAYED RELEASE in 1 BOTTLE (11534-201-07) | 2025-12-11 | No | No | Current |