🇺🇸
United States · US · US:80005-126_8bfef633-a30b-4aac-b768-cce1c8e151c4
balsalazide disodium
Orange BookUNIISPLATC A07EC04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCarnegie Pharmaceuticals, LLC
CountryUS (United States)
ATC codeA07EC04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc118000512625280 CAPSULE in 1 BOTTLE (80005-126-25)
Annotations
UNII (FDA Substance ID)
1XL6BJI034
BALSALAZIDE DISODIUM
RxCUI 153718
Orange Book
A219422
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "1XL6BJI034",
"rxcui": "153718",
"inchikey": "XDCNKOBSQURQOZ-MVIJUDHYSA-L",
"display_name": "BALSALAZIDE DISODIUM",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"509b83b6-cde6-393b-8560-557793b6a529": {
"match": "brand_token",
"title": "BALSALAZIDE DISODIUM CAPSULE [AVPAK]",
"spl_version": "10",
"published_date": "2025-12-31"
}
},
"productid": "80005-126_8bfef633-a30b-4aac-b768-cce1c8e151c4",
"productndc": "80005-126",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "219422",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "750MG",
"product_no": "001",
"approval_date": "Apr 3, 2025"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BALSALAZIDE DISODIUM",
"proprietary_name": "balsalazide disodium",
"active_ingred_unit": "mg/1",
"application_number": "ANDA219422",
"marketing_category": "ANDA",
"nonproprietary_name": "balsalazide disodium",
"start_marketing_date": "20250630",
"active_numerator_strength": "750"
}Related drugs
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- 🇺🇸Balsalazide DisodiumAvPAK
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