SULFASALAZINE
- Product NDC
- 68788-9021
- 11-digit product format
- 687889021
- Labeler code
- 68788
- Product ID
- 68788-9021_96656bd0-2dc8-4119-b9fa-5df199e49527
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SULFASALAZINE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals, Inc
- Application
- ANDA087197
- Marketing category
- ANDA
- Marketing start
- 2010-06-09
- Marketing end
- 0000-00-00
- Substance
- SULFASALAZINE
- Active strength
- 500 mg/1
- Pharmacologic classes
- Aminosalicylate [EPC],Aminosalicylic Acids [CS]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 68788-9021 | D | Discontinued by firm | 2026-07-31 | ||
| excluded package | package | 68788-9021 | 68788-9021-1 | D | Discontinued by firm | 2026-07-31 | |
| excluded package | package | 68788-9021 | 68788-9021-3 | D | Discontinued by firm | 2026-07-31 | |
| excluded package | package | 68788-9021 | 68788-9021-6 | D | Discontinued by firm | 2026-07-31 | |
| excluded package | package | 68788-9021 | 68788-9021-9 | D | Discontinued by firm | 2026-07-31 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A087197-001 | SULFASALAZINE | SULFASALAZINE | 500MG | TABLET / ORAL | Approved before 1982 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| SULFASALAZINE | ACTIVE INGREDIENT | 3XC8GUZ6CB | SULFASALAZINE TABLET [PREFERRED PHARMACEUTICALS, INC] | 1 | |
| SULFASALAZINE | ACTIVE MOIETY | 3XC8GUZ6CB | SULFASALAZINE TABLET [PREFERRED PHARMACEUTICALS, INC] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | SULFASALAZINE TABLET [PREFERRED PHARMACEUTICALS, INC] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | SULFASALAZINE TABLET [PREFERRED PHARMACEUTICALS, INC] | 1 | |
| SODIUM STEAROYL LACTYLATE | INACTIVE INGREDIENT | IN99IT31LN | SULFASALAZINE TABLET [PREFERRED PHARMACEUTICALS, INC] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | SULFASALAZINE TABLET [PREFERRED PHARMACEUTICALS, INC] | 1 |