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United States · US · US:55741-449_bed562f2-f5b3-632b-4b2c-fdf34a061098
nicotine
Orange BookSPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerDr. Reddy's Laboratories Inc.
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11557414495656 PATCH in 1 CARTON (55741-449-56) / 1 KIT in 1 PATCH
Annotations
Orange Book
N020076
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"route": "TRANSDERMAL",
"spl_meta": {
"f1eb8d9f-1c9a-4c8a-833b-ced0ec01ed5c": {
"match": "brand_token",
"title": "NICOTINE (NICOTINE POLACRILEX) LOZENGE [RITE AID CORPORATION]",
"spl_version": "5",
"published_date": "2026-06-01"
}
},
"productid": "55741-449_bed562f2-f5b3-632b-4b2c-fdf34a061098",
"productndc": "55741-449",
"dosage_form": "KIT",
"orange_book": {
"appl_no": "020076",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "7MG/24HR",
"product_no": "004",
"approval_date": "Nov 12, 1999"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "14MG/24HR",
"product_no": "005",
"approval_date": "Nov 12, 1999"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "21MG/24HR",
"product_no": "006",
"approval_date": "Nov 12, 1999"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": null,
"proprietary_name": "nicotine",
"active_ingred_unit": null,
"application_number": "NDA020076",
"marketing_category": "NDA",
"nonproprietary_name": "nicotine",
"start_marketing_date": "20150514",
"active_numerator_strength": null
}Access this data programmatically
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