🇺🇸
United States · US · US:0054-0079_6f5a92d7-1828-44ea-8265-0ed1b3bef16c
Balsalazide Disodium
Orange BookUNIISPLATC A07EC04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHikma Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeA07EC04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc110054007928280 CAPSULE in 1 BOTTLE (0054-0079-28)
Annotations
UNII (FDA Substance ID)
1XL6BJI034
BALSALAZIDE DISODIUM
RxCUI 153718
Orange Book
A077806
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": "0054-0079_6f5a92d7-1828-44ea-8265-0ed1b3bef16c",
"productndc": "0054-0079",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "077806",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "750MG",
"product_no": "001",
"approval_date": "Dec 28, 2007"
}
],
"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": "ANDA077806",
"marketing_category": "ANDA",
"nonproprietary_name": "Balsalazide Disodium",
"start_marketing_date": "20071228",
"active_numerator_strength": "750"
}Related drugs
Other records sharing ATC code A07EC04.
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- 🇺🇸balsalazide disodiumZydus Lifesciences Limited
- 🇺🇸Balsalazide DisodiumApotex Corp.
- 🇺🇸Balsalazide DisodiumPD-Rx Pharmaceuticals, Inc.
- 🇺🇸Balsalazide DisodiumAvPAK
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