🇺🇸
United States · US · US:55494-120_3e4fbcb3-ac64-4673-b46f-a2ce616d4374
BONJESTA
In shortageOrange BookUNIISPLATC R06AA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerDuchesnay USA, Inc.
CountryUS (United States)
ATC codeR06AA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc115549412010100 TABLET, EXTENDED RELEASE in 1 BOTTLE (55494-120-10)
- ndc11554941206060 TABLET, EXTENDED RELEASE in 1 BOTTLE (55494-120-60)
- ndc1155494120941 BLISTER PACK in 1 CARTON (55494-120-94) / 4 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
- ndc1155494120996 TABLET, EXTENDED RELEASE in 1 BOTTLE (55494-120-99)
Annotations
UNII (FDA Substance ID)
V9BI9B5YI2
DOXYLAMINE SUCCINATE
RxCUI 23665
Orange Book
N209661
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Doxylamine Succinate and Pyridoxine Hydrochloride Tablet, Delayed Release
Raw payload (JSON)
{
"unii": {
"unii": "V9BI9B5YI2",
"rxcui": "23665",
"inchikey": "KBAUFVUYFNWQFM-UHFFFAOYSA-N",
"display_name": "DOXYLAMINE SUCCINATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"dba60bb4-54ff-4e06-b8d2-acbbd3717666": {
"match": "brand_token",
"title": "BONJESTA (DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DUCHESNAY USA, INC.]",
"spl_version": "13",
"published_date": "2025-02-28"
}
},
"productid": "55494-120_3e4fbcb3-ac64-4673-b46f-a2ce616d4374",
"productndc": "55494-120",
"dosage_form": "TABLET, EXTENDED RELEASE",
"orange_book": {
"appl_no": "209661",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "20MG;20MG",
"product_no": "001",
"approval_date": "Nov 7, 2016"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE",
"shortage_reason": "Doxylamine Succinate and Pyridoxine Hydrochloride Tablet, Delayed Release",
"shortage_status": "current",
"proprietary_name": "BONJESTA",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "NDA209661",
"marketing_category": "NDA",
"nonproprietary_name": "doxylamine succinate and pyridoxine hydrochloride",
"start_marketing_date": "20180219",
"active_numerator_strength": "20; 20"
}Related drugs
Other records sharing ATC code R06AA.
- 🇪🇸BONJESTA 10 MG/10 MG COMPRIMIDOS GASTRORRESISTENTESExeltis Healthcare S.L.
- 🇪🇸BONJESTA 20 MG/20 MG COMPRIMIDOS DE LIBERACIÓN MODIFICADAExeltis Healthcare S.L.
- GBDiclectin modified-release tabletsImported (Canada)
- 🇺🇸DICLEGISDuchesnay USA, Inc.
- 🇺🇸Doxylamine succinate and pyridoxine hydrochlorideAnalog Pharma
- 🇺🇸Doxylamine succinate and pyridoxine hydrochlorideActavis Pharma, Inc.
- 🇺🇸Doxylamine succinate and Pyridoxine hydrochlorideBionpharma Inc.,
- 🇺🇸Doxylamine Succinate and Pyridoxine HydrochlorideBryant Ranch Prepack
Access this data programmatically
Query BONJESTA and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.