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NDC 23155-0019-05 Sulfasalazine 500 mg/1 Details
Sulfasalazine 500 mg/1
Sulfasalazine is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.. The primary component is SULFASALAZINE.
MedlinePlus Drug Summary
Sulfasalazine is used to treat ulcerative colitis (a condition which causes swelling and sores in the lining of the colon [large intestine] and rectum) and also to maintain improvement of ulcerative colitis symptoms. Sulfasalazine delayed-release (Azulfidine EN-tabs) is also used to treat rheumatoid arthritis in adults whose disease has not responded well to other medications or could not be tolerated. Sulfasalazine delayed-release (Azulfidine EN-tabs) is also used to treat polyarticular juvenile idiopathic arthritis (PJIA; a type of childhood arthritis that affects five or more joints during the first six months of the condition, causing pain, swelling, and loss of function) in children who have not been helped by other medications. Sulfasalazine is in a class of medications called anti-inflammatory drugs. It works by reducing inflammation (swelling) inside the body.
Related Packages: 23155-0019-05Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Sulfasalazine
Product Information
| NDC | 23155-0019 |
|---|---|
| Product ID | 23155-019_855bcbd0-211b-4fdd-b8bb-8a1ad2238171 |
| Associated GPIs | 52500060000310 |
| GCN Sequence Number | 009402 |
| GCN Sequence Number Description | sulfasalazine TABLET 500 MG ORAL |
| HIC3 | D6F |
| HIC3 Description | DRUG TX-CHRONIC INFLAM. COLON DX,5-AMINOSALICYLAT |
| GCN | 41611 |
| HICL Sequence Number | 004074 |
| HICL Sequence Number Description | SULFASALAZINE |
| Brand/Generic | Generic |
| Proprietary Name | Sulfasalazine |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Sulfasalazine |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 500 |
| Active Ingredient Units | mg/1 |
| Substance Name | SULFASALAZINE |
| Labeler Name | HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC. |
| Pharmaceutical Class | Aminosalicylate [EPC], Aminosalicylic Acids [CS] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA080197 |
| Listing Certified Through | n/a |
Package
NDC 23155-0019-05 (23155001905)
| NDC Package Code | 23155-019-05 |
|---|---|
| Billing NDC | 23155001905 |
| Package | 500 TABLET in 1 BOTTLE (23155-019-05) |
| Marketing Start Date | 2021-05-07 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |