Sulfasalazine
- Product NDC
- 0093-3234
- 11-digit product format
- 000933234
- Labeler code
- 0093
- Product ID
- 0093-3234_6bb77fd9-0f19-4f91-8eb9-33d9c6b5c471
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sulfasalazine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Teva Pharmaceuticals USA, Inc.
- Application
- ANDA085828
- Marketing category
- ANDA
- Marketing start
- 2022-12-15
- 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 |
|---|
| 0093-3234-01 | Sulfasalazine | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | | 5 |
| 0093-3234-05 | Sulfasalazine | 500 in 1 BOTTLE, PLASTIC | TABLET | 500 | | 5 |
| 0093-3234-10 | Sulfasalazine | 1000 in 1 BOTTLE, PLASTIC | TABLET | 1000 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0093-3234 | SULFASALAZINE TABLET [TEVA PHARMACEUTICALS USA, INC.] | 5 | Current NDC, Legacy NDC, 3 package rows | 20230907_3c59593b-e1a5-47cb-a82b-3e5e49205344.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0093-3234-01 | 00093323401 | 100 TABLET in 1 BOTTLE, PLASTIC (0093-3234-01) | 100 tablet | 2022-12-15 | 0000-00-00 | No | No | Current |
| 0093-3234-05 | 00093323405 | 500 TABLET in 1 BOTTLE, PLASTIC (0093-3234-05) | 500 tablet | 2023-02-27 | | No | No | Current |
| 0093-3234-10 | 00093323410 | 1000 TABLET in 1 BOTTLE, PLASTIC (0093-3234-10) | 1000 tablet | 2022-12-15 | 0000-00-00 | No | No | Current |