sulfadiazine

Generic: sulfadiazine

Labeler: epic pharma, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sulfadiazine
Generic Name sulfadiazine
Labeler epic pharma, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

sulfadiazine 500 mg/1

Manufacturer
EPIC PHARMA, LLC

Identifiers & Regulatory

Product NDC 42806-757
Product ID 42806-757_69f2d77c-8279-4524-93c2-f199e7973400
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040091
Listing Expiration 2026-12-31
Marketing Start 2021-12-15

Pharmacologic Class

Established (EPC)
sulfonamide antibacterial [epc]
Chemical Structure
sulfonamides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42806757
Hyphenated Format 42806-757

Supplemental Identifiers

RxCUI
198228
UPC
0342806757604
UNII
0N7609K889
NUI
N0000175503 M0020790

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 sulfadiazine (source: ndc)
Generic Name sulfadiazine (source: ndc)
Application Number ANDA040091 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 60 TABLET in 1 BOTTLE (42806-757-60)
source: ndc

Packages (1)

42806-757-60 60 TABLET in 1 BOTTLE (42806-757-60)

Ingredients (1)

sulfadiazine (500 mg/1)

Linked Drug Pages (1)

SULFADIAZINE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "69f2d77c-8279-4524-93c2-f199e7973400", "openfda": {"nui": ["N0000175503", "M0020790"], "upc": ["0342806757604"], "unii": ["0N7609K889"], "rxcui": ["198228"], "spl_set_id": ["8993651b-fff6-4e3f-9b60-78587bc9bcee"], "pharm_class_cs": ["Sulfonamides [CS]"], "pharm_class_epc": ["Sulfonamide Antibacterial [EPC]"], "manufacturer_name": ["EPIC PHARMA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET in 1 BOTTLE (42806-757-60)", "package_ndc": "42806-757-60", "marketing_start_date": "20211215"}], "brand_name": "SULFADIAZINE", "product_id": "42806-757_69f2d77c-8279-4524-93c2-f199e7973400", "dosage_form": "TABLET", "pharm_class": ["Sulfonamide Antibacterial [EPC]", "Sulfonamides [CS]"], "product_ndc": "42806-757", "generic_name": "sulfadiazine", "labeler_name": "EPIC PHARMA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SULFADIAZINE", "active_ingredients": [{"name": "SULFADIAZINE", "strength": "500 mg/1"}], "application_number": "ANDA040091", "marketing_category": "ANDA", "marketing_start_date": "20211215", "listing_expiration_date": "20261231"}