azulfidine en-tabs

Generic: sulfasalazine

Labeler: pfizer laboratories div pfizer inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name azulfidine en-tabs
Generic Name sulfasalazine
Labeler pfizer laboratories div pfizer inc
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

sulfasalazine 500 mg/1

Manufacturer
Pfizer Laboratories Div Pfizer Inc

Identifiers & Regulatory

Product NDC 0013-0102
Product ID 0013-0102_e085ce86-abc0-4032-a3c9-ca89bae152d9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA007073
Listing Expiration 2026-12-31
Marketing Start 1950-06-20

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00130102
Hyphenated Format 0013-0102

Supplemental Identifiers

RxCUI
313142 724154
UNII
3XC8GUZ6CB
NUI
N0000175781 M0000971

Packaging Origin

Original Packager
true

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 azulfidine en-tabs (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
  • 1 BOTTLE in 1 CARTON (0013-0102-50) / 100 TABLET, DELAYED RELEASE in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (0013-0102-60) / 300 TABLET, DELAYED RELEASE in 1 BOTTLE
source: ndc

Packages (2)

0013-0102-50 1 BOTTLE in 1 CARTON (0013-0102-50) / 100 TABLET, DELAYED RELEASE in 1 BOTTLE 0013-0102-60 1 BOTTLE in 1 CARTON (0013-0102-60) / 300 TABLET, DELAYED RELEASE in 1 BOTTLE

Ingredients (1)

sulfasalazine (500 mg/1)

Linked Drug Pages (1)

Azulfidine EN-tabs ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "e085ce86-abc0-4032-a3c9-ca89bae152d9", "openfda": {"nui": ["N0000175781", "M0000971"], "unii": ["3XC8GUZ6CB"], "rxcui": ["313142", "724154"], "spl_set_id": ["b9ef541a-93c8-4428-ba45-398aa0b327d1"], "pharm_class_cs": ["Aminosalicylic Acids [CS]"], "pharm_class_epc": ["Aminosalicylate [EPC]"], "manufacturer_name": ["Pfizer Laboratories Div Pfizer Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (0013-0102-50)  / 100 TABLET, DELAYED RELEASE in 1 BOTTLE", "package_ndc": "0013-0102-50", "marketing_start_date": "20200707"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (0013-0102-60)  / 300 TABLET, DELAYED RELEASE in 1 BOTTLE", "package_ndc": "0013-0102-60", "marketing_start_date": "20210215"}], "brand_name": "Azulfidine EN-tabs", "product_id": "0013-0102_e085ce86-abc0-4032-a3c9-ca89bae152d9", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Aminosalicylate [EPC]", "Aminosalicylic Acids [CS]"], "product_ndc": "0013-0102", "generic_name": "Sulfasalazine", "labeler_name": "Pfizer Laboratories Div Pfizer Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Azulfidine", "brand_name_suffix": "EN-tabs", "active_ingredients": [{"name": "SULFASALAZINE", "strength": "500 mg/1"}], "application_number": "NDA007073", "marketing_category": "NDA", "marketing_start_date": "19500620", "listing_expiration_date": "20261231"}