Sulfasalazine
- Product NDC
- 16571-261
- 11-digit product format
- 165710261
- Labeler code
- 16571
- Product ID
- 16571-261_4b43540c-2b08-44cb-81b8-4308dea2c141
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sulfasalazine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Rising Pharma Holdings, Inc.
- Application
- ANDA219046
- Marketing category
- ANDA
- Marketing start
- 2025-11-04
- 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 | 198232 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 16571-261-01 | Sulfasalazine | 100 in 1 CONTAINER | TABLET | 100 | | 1 |
| 16571-261-30 | Sulfasalazine | 300 in 1 CONTAINER | TABLET | 300 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 16571-261-01 | 16571026101 | 100 TABLET in 1 CONTAINER (16571-261-01) | 100 tablet | 2025-11-04 | No | No | Current |
| 16571-261-30 | 16571026130 | 300 TABLET in 1 CONTAINER (16571-261-30) | 300 tablet | 2025-11-04 | No | No | Current |