azulfidine

Generic: sulfasalazine

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

Drug Facts

Product Profile

Brand Name azulfidine
Generic Name sulfasalazine
Labeler pfizer laboratories div pfizer inc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

sulfasalazine 500 mg/1

Manufacturer
Pfizer Laboratories Div Pfizer Inc

Identifiers & Regulatory

Product NDC 0013-0101
Product ID 0013-0101_cb6e4f45-60ee-44cd-a4d3-ea2445d5bda6
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 00130101
Hyphenated Format 0013-0101

Supplemental Identifiers

RxCUI
198232 208437
UPC
0300130101012
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 (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 (0013-0101-10) / 100 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (0013-0101-30) / 300 TABLET in 1 BOTTLE
source: ndc

Packages (2)

0013-0101-10 1 BOTTLE in 1 CARTON (0013-0101-10) / 100 TABLET in 1 BOTTLE 0013-0101-30 1 BOTTLE in 1 CARTON (0013-0101-30) / 300 TABLET in 1 BOTTLE

Ingredients (1)

sulfasalazine (500 mg/1)

Linked Drug Pages (1)

Azulfidine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "cb6e4f45-60ee-44cd-a4d3-ea2445d5bda6", "openfda": {"nui": ["N0000175781", "M0000971"], "upc": ["0300130101012"], "unii": ["3XC8GUZ6CB"], "rxcui": ["198232", "208437"], "spl_set_id": ["ddbe69f3-bd55-45f3-a64f-f60226c744c4"], "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 (0013-0101-10)  / 100 TABLET in 1 BOTTLE", "package_ndc": "0013-0101-10", "marketing_start_date": "20200227"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (0013-0101-30)  / 300 TABLET in 1 BOTTLE", "package_ndc": "0013-0101-30", "marketing_start_date": "20200227"}], "brand_name": "Azulfidine", "product_id": "0013-0101_cb6e4f45-60ee-44cd-a4d3-ea2445d5bda6", "dosage_form": "TABLET", "pharm_class": ["Aminosalicylate [EPC]", "Aminosalicylic Acids [CS]"], "product_ndc": "0013-0101", "generic_name": "Sulfasalazine", "labeler_name": "Pfizer Laboratories Div Pfizer Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Azulfidine", "active_ingredients": [{"name": "SULFASALAZINE", "strength": "500 mg/1"}], "application_number": "NDA007073", "marketing_category": "NDA", "marketing_start_date": "19500620", "listing_expiration_date": "20261231"}