🇺🇸
United States · US · US:70505-100_59e091eb-f626-4083-b134-8d648d28b918
Doxylamine succinate and pyridoxine hydrochloride
In shortageOrange BookUNIISPLATC R06AA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAnalog Pharma
CountryUS (United States)
ATC codeR06AA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc117050510010100 TABLET, DELAYED RELEASE in 1 BOTTLE (70505-100-10)
Annotations
UNII (FDA Substance ID)
V9BI9B5YI2
DOXYLAMINE SUCCINATE
RxCUI 23665
Orange Book
N021876
AB
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": {
"0c410285-0ad6-aabc-e063-6294a90abcd8": {
"match": "brand_token",
"title": "DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE TABLET, DELAYED RELEASE [BIONPHARMA INC.,]",
"spl_version": "2",
"published_date": "2025-12-05"
}
},
"productid": "70505-100_59e091eb-f626-4083-b134-8d648d28b918",
"productndc": "70505-100",
"dosage_form": "TABLET, DELAYED RELEASE",
"orange_book": {
"appl_no": "021876",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "10MG;10MG",
"product_no": "001",
"approval_date": "Apr 8, 2013"
}
],
"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": "Doxylamine succinate and pyridoxine hydrochloride",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "NDA021876",
"marketing_category": "NDA AUTHORIZED GENERIC",
"nonproprietary_name": "Doxylamine succinate and pyridoxine hydrochloride",
"start_marketing_date": "20181115",
"active_numerator_strength": "10; 10"
}Related drugs
Other records sharing ATC code R06AA.
- 🇺🇸BONJESTADuchesnay USA, Inc.
- 🇪🇸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 hydrochlorideActavis Pharma, Inc.
- 🇺🇸Doxylamine succinate and Pyridoxine hydrochlorideBionpharma Inc.,
- 🇺🇸Doxylamine Succinate and Pyridoxine HydrochlorideBryant Ranch Prepack
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