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United States · US · US:0456-1203_621456b5-c1a3-48b8-99ac-ccbf8beebf43
Linzess
Orange BookUNIISPLATC A06AX04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAllergan, Inc.
CountryUS (United States)
ATC codeA06AX04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1104561203041 BOTTLE in 1 CARTON (0456-1203-04) / 4 CAPSULE, GELATIN COATED in 1 BOTTLE
- ndc1104561203071 BOTTLE in 1 CARTON (0456-1203-07) / 7 CAPSULE, GELATIN COATED in 1 BOTTLE
- ndc1104561203301 BOTTLE in 1 CARTON (0456-1203-30) / 30 CAPSULE, GELATIN COATED in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
N0TXR0XR5X
LINACLOTIDE
RxCUI 1307404
Orange Book
N202811
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "N0TXR0XR5X",
"rxcui": "1307404",
"inchikey": null,
"display_name": "LINACLOTIDE",
"substance_type": "protein",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"09beda19-56d6-4a56-afdc-9a77b70b2ef3": {
"match": "brand_token",
"title": "LINZESS (LINACLOTIDE) CAPSULE, GELATIN COATED [ALLERGAN, INC.]",
"spl_version": "39",
"published_date": "2026-06-01"
}
},
"productid": "0456-1203_621456b5-c1a3-48b8-99ac-ccbf8beebf43",
"productndc": "0456-1203",
"dosage_form": "CAPSULE, GELATIN COATED",
"orange_book": {
"appl_no": "202811",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "145MCG",
"product_no": "001",
"approval_date": "Aug 30, 2012"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "290MCG",
"product_no": "002",
"approval_date": "Aug 30, 2012"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "72MCG",
"product_no": "003",
"approval_date": "Jan 25, 2017"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LINACLOTIDE",
"proprietary_name": "Linzess",
"active_ingred_unit": "ug/1",
"application_number": "NDA202811",
"marketing_category": "NDA",
"nonproprietary_name": "linaclotide",
"start_marketing_date": "20170130",
"active_numerator_strength": "72"
}Related drugs
Other records sharing ATC code A06AX04.
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