🇺🇸
United States · US · US:68391-957_357123fc-0972-4683-ab52-f95d46c1b6c9
berkley and jensen nicotine
Orange BookUNIISPLATC N07BA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBJWC
CountryUS (United States)
ATC codeN07BA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11683919570127 LOZENGE in 1 BOTTLE (68391-957-01)
- ndc1168391957067 BOTTLE in 1 PACKAGE (68391-957-06) / 27 LOZENGE in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
6M3C89ZY6R
NICOTINE
RxCUI 7407
Orange Book
A203690
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "6M3C89ZY6R",
"rxcui": "7407",
"inchikey": "SNICXCGAKADSCV-JTQLQIEISA-N",
"display_name": "NICOTINE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"cda57e42-6106-46ee-82d1-479a692ee5bb": {
"match": "brand_token",
"title": "BERKLEY AND JENSEN IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [BJWC]",
"spl_version": "9",
"published_date": "2026-05-25"
}
},
"productid": "68391-957_357123fc-0972-4683-ab52-f95d46c1b6c9",
"productndc": "68391-957",
"dosage_form": "LOZENGE",
"orange_book": {
"appl_no": "203690",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 2MG BASE",
"product_no": "001",
"approval_date": "Oct 9, 2012"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 4MG BASE",
"product_no": "002",
"approval_date": "Oct 9, 2012"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "NICOTINE",
"proprietary_name": "berkley and jensen nicotine",
"active_ingred_unit": "mg/1",
"application_number": "ANDA203690",
"marketing_category": "ANDA",
"nonproprietary_name": "Nicotine Polacrilex",
"start_marketing_date": "20171106",
"active_numerator_strength": "4"
}Related drugs
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