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United States · US · US:63629-8679_3735ed2d-e468-4890-813a-991f3aa5fd48
Mesalamine
Orange BookSPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1163629867914 CARTON in 1 KIT (63629-8679-1) / 1 KIT in 1 CARTON * 60 mL in 1 BOTTLE (45802-098-46) * 1 SWAB in 1 PACKET
Annotations
Orange Book
A076751
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"route": null,
"spl_meta": {
"485ed763-976e-4410-a401-7ff762a931b3": {
"match": "brand_token",
"title": "MESALAMINE SUSPENSION [ANI PHARMACEUTICALS, INC.]",
"spl_version": "3",
"published_date": "2026-05-21"
}
},
"productid": "63629-8679_3735ed2d-e468-4890-813a-991f3aa5fd48",
"productndc": "63629-8679",
"dosage_form": "KIT",
"orange_book": {
"appl_no": "076751",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "4GM/60ML",
"product_no": "001",
"approval_date": "Sep 17, 2004"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": null,
"proprietary_name": "Mesalamine",
"active_ingred_unit": null,
"application_number": "ANDA076751",
"marketing_category": "ANDA",
"nonproprietary_name": "Mesalamine",
"start_marketing_date": "20180802",
"active_numerator_strength": null
}Access this data programmatically
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