Sulfasalazine
- Product NDC
- 62135-960
- 11-digit product format
- 621350960
- Labeler code
- 62135
- Product ID
- 62135-960_ef9f56ad-c921-6fe7-e053-2a95a90a85af
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sulfasalazine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Chartwell RX, LLC.
- Application
- ANDA080197
- Marketing category
- ANDA
- Marketing start
- 1973-11-12
- 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 |
|---|
| 62135-960-01 | Sulfasalazine | 100 in 1 BOTTLE | TABLET | 100 | | 6 |
| 62135-960-05 | Sulfasalazine | 500 in 1 BOTTLE | TABLET | 500 | | 6 |
| 62135-960-10 | Sulfasalazine | 1000 in 1 BOTTLE | TABLET | 1000 | | 6 |
| 62135-960-31 | Sulfasalazine | 300 in 1 BOTTLE | TABLET | 300 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62135-960 | SULFASALAZINE TABLET [CHARTWELL RX, LLC.] | 6 | Current NDC, Legacy NDC, 4 package rows | 20221213_029716bd-ee1a-484c-bf1f-ec8d02d5281b.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 |
|---|
| 62135-960-01 | 62135096001 | 100 TABLET in 1 BOTTLE (62135-960-01) | 100 tablet | 2021-05-07 | 0000-00-00 | No | No | Current |
| 62135-960-05 | 62135096005 | 500 TABLET in 1 BOTTLE (62135-960-05) | 500 tablet | 2021-05-07 | 0000-00-00 | No | No | Current |
| 62135-960-10 | 62135096010 | 1000 TABLET in 1 BOTTLE (62135-960-10) | 1000 tablet | 2021-05-07 | 0000-00-00 | No | No | Current |
| 62135-960-31 | 62135096031 | 300 TABLET in 1 BOTTLE (62135-960-31) | 300 tablet | 2021-05-07 | 0000-00-00 | No | No | Current |