sulfasalazine

Generic: sulfasalazine

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name sulfasalazine
Generic Name sulfasalazine
Labeler remedyrepack inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

sulfasalazine 500 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-1829
Product ID 70518-1829_4976ef9d-bb2f-1498-e063-6294a90a81d2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA007073
Listing Expiration 2027-12-31
Marketing Start 2019-01-28

Pharmacologic Class

Established (EPC)
aminosalicylate [epc]
Chemical Structure
aminosalicylic acids [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705181829
Hyphenated Format 70518-1829

Supplemental Identifiers

RxCUI
198232
UNII
3XC8GUZ6CB
NUI
N0000175781 M0000971

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name sulfasalazine (source: ndc)
Generic Name sulfasalazine (source: ndc)
Application Number NDA007073 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BLISTER PACK (70518-1829-3)
source: ndc

Packages (1)

70518-1829-3 30 TABLET in 1 BLISTER PACK (70518-1829-3)

Ingredients (1)

sulfasalazine (500 mg/1)

Linked Drug Pages (1)

Sulfasalazine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4976ef9d-bb2f-1498-e063-6294a90a81d2", "openfda": {"nui": ["N0000175781", "M0000971"], "unii": ["3XC8GUZ6CB"], "rxcui": ["198232"], "spl_set_id": ["88441a9f-b4f9-455d-a355-46fb30699a7b"], "pharm_class_cs": ["Aminosalicylic Acids [CS]"], "pharm_class_epc": ["Aminosalicylate [EPC]"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BLISTER PACK (70518-1829-3)", "package_ndc": "70518-1829-3", "marketing_start_date": "20211029"}], "brand_name": "Sulfasalazine", "product_id": "70518-1829_4976ef9d-bb2f-1498-e063-6294a90a81d2", "dosage_form": "TABLET", "pharm_class": ["Aminosalicylate [EPC]", "Aminosalicylic Acids [CS]"], "product_ndc": "70518-1829", "generic_name": "Sulfasalazine", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sulfasalazine", "active_ingredients": [{"name": "SULFASALAZINE", "strength": "500 mg/1"}], "application_number": "NDA007073", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20190128", "listing_expiration_date": "20271231"}