🇺🇸
United States · US · US:49884-186_19e74a3b-edba-41e5-afe6-fba1b9765ad1
Doxylamine Succinate and Pyridoxine Hydrochloride
In shortageOrange BookUNIISPLATC R06AA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerEndo USA, Inc.
CountryUS (United States)
ATC codeR06AA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc114988418601100 TABLET, DELAYED RELEASE in 1 BOTTLE (49884-186-01)
Annotations
UNII (FDA Substance ID)
V9BI9B5YI2
DOXYLAMINE SUCCINATE
RxCUI 23665
Orange Book
A208518
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": "49884-186_19e74a3b-edba-41e5-afe6-fba1b9765ad1",
"productndc": "49884-186",
"dosage_form": "TABLET, DELAYED RELEASE",
"orange_book": {
"appl_no": "208518",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG;10MG",
"product_no": "001",
"approval_date": "Dec 6, 2017"
}
],
"appl_type": "A"
},
"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": "ANDA208518",
"marketing_category": "ANDA",
"nonproprietary_name": "Doxylamine Succinate and Pyridoxine Hydrochloride, Delayed release Tablets 10 mg/10 mg",
"start_marketing_date": "20191219",
"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 hydrochlorideAnalog Pharma
- 🇺🇸Doxylamine succinate and pyridoxine hydrochlorideActavis Pharma, Inc.
- 🇺🇸Doxylamine succinate and Pyridoxine hydrochlorideBionpharma Inc.,
Access this data programmatically
Query Doxylamine Succinate and Pyridoxine Hydrochloride 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.