Nucynta

Orange BookUNIISPLATC N02AX06

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerCollegium Pharmaceutical, Inc.

CountryUS (United States)

ATC codeN02AX06

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
2451011601
10 BLISTER PACK in 1 CARTON (24510-116-01) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
ndc11
2451011660
60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (24510-116-60)

Annotations

UNII (FDA Substance ID)

71204KII53

TAPENTADOL HYDROCHLORIDE

RxCUI 857492

Orange Book

N200533

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": "24510-116_2d370c0d-8d66-446f-be46-ed92e0f1cf6b",
  "productndc": "24510-116",
  "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "200533",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 50MG BASE",
        "product_no": "001",
        "approval_date": "Aug 25, 2011"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 100MG BASE",
        "product_no": "002",
        "approval_date": "Aug 25, 2011"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 150MG BASE",
        "product_no": "003",
        "approval_date": "Aug 25, 2011"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 200MG BASE",
        "product_no": "004",
        "approval_date": "Aug 25, 2011"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 250MG BASE",
        "product_no": "005",
        "approval_date": "Aug 25, 2011"
      }
    ],
    "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": "NDA200533",
  "marketing_category": "NDA",
  "nonproprietary_name": "tapentadol hydrochloride",
  "start_marketing_date": "20190419",
  "active_numerator_strength": "100"
}

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