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United States · US · US:24510-075_3f155622-a850-4d63-9539-9e645a8fcc28
Nucynta
Orange BookUNIISPLATC N02AX06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCollegium Pharmaceutical, Inc.
CountryUS (United States)
ATC codeN02AX06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11245100750110 BLISTER PACK in 1 CARTON (24510-075-01) / 10 TABLET, FILM COATED in 1 BLISTER PACK
- ndc112451007510100 TABLET, FILM COATED in 1 BOTTLE (24510-075-10)
Annotations
UNII (FDA Substance ID)
71204KII53
TAPENTADOL HYDROCHLORIDE
RxCUI 857492
Orange Book
N022304
ABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "71204KII53",
"rxcui": "857492",
"inchikey": "ZELFLGGRLLOERW-YECZQDJWSA-N",
"display_name": "TAPENTADOL HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"80938c30-9fe3-4c7d-9d9c-5476638cfb2d": {
"match": "brand_token",
"title": "NUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [COLLEGIUM PHARMACEUTICAL, INC.]",
"spl_version": "7",
"published_date": "2026-01-06"
}
},
"productid": "24510-075_3f155622-a850-4d63-9539-9e645a8fcc28",
"productndc": "24510-075",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "022304",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "EQ 50MG BASE",
"product_no": "001",
"approval_date": "Nov 20, 2008"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "EQ 75MG BASE",
"product_no": "002",
"approval_date": "Nov 20, 2008"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "EQ 100MG BASE",
"product_no": "003",
"approval_date": "Nov 20, 2008"
}
],
"appl_type": "N"
},
"dea_schedule": "CII",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TAPENTADOL HYDROCHLORIDE",
"proprietary_name": "Nucynta",
"active_ingred_unit": "mg/1",
"application_number": "NDA022304",
"marketing_category": "NDA",
"nonproprietary_name": "tapentadol hydrochloride",
"start_marketing_date": "20190401",
"active_numerator_strength": "75"
}Related drugs
Other records sharing ATC code N02AX06.
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