sulfadiazine

Generic: sulfadiazine

Labeler: chartwell rx, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sulfadiazine
Generic Name sulfadiazine
Labeler chartwell rx, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

sulfadiazine 500 mg/1

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-842
Product ID 62135-842_22e33608-9604-ec44-e063-6394a90a3d12
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA080084
Listing Expiration 2026-12-31
Marketing Start 2024-09-23

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62135842
Hyphenated Format 62135-842

Supplemental Identifiers

RxCUI
198228
UPC
0362135842604
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 ANDA080084 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 60 TABLET in 1 BOTTLE (62135-842-60)
source: ndc

Packages (1)

62135-842-60 60 TABLET in 1 BOTTLE (62135-842-60)

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": "22e33608-9604-ec44-e063-6394a90a3d12", "openfda": {"nui": ["N0000175503", "M0020790"], "upc": ["0362135842604"], "unii": ["0N7609K889"], "rxcui": ["198228"], "spl_set_id": ["6032d6f7-cbce-4e5d-841c-a1e24b616f91"], "pharm_class_cs": ["Sulfonamides [CS]"], "pharm_class_epc": ["Sulfonamide Antibacterial [EPC]"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET in 1 BOTTLE (62135-842-60)", "package_ndc": "62135-842-60", "marketing_start_date": "20240923"}], "brand_name": "sulfADIAZINE", "product_id": "62135-842_22e33608-9604-ec44-e063-6394a90a3d12", "dosage_form": "TABLET", "pharm_class": ["Sulfonamide Antibacterial [EPC]", "Sulfonamides [CS]"], "product_ndc": "62135-842", "generic_name": "sulfADIAZINE", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "sulfADIAZINE", "active_ingredients": [{"name": "SULFADIAZINE", "strength": "500 mg/1"}], "application_number": "ANDA080084", "marketing_category": "ANDA", "marketing_start_date": "20240923", "listing_expiration_date": "20261231"}