🇺🇸
United States · US · US:55494-100_19a108be-4aba-4906-8a5d-35f5b263b1c2
DICLEGIS
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 · 2
- ndc115549410010100 TABLET, DELAYED RELEASE in 1 BOTTLE (55494-100-10)
- ndc11554941009912 TABLET, DELAYED RELEASE in 1 BOTTLE (55494-100-99)
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": {
"8bde08f6-e8bd-4e90-baa7-82e01876a86a": {
"match": "brand_token",
"title": "DICLEGIS (DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE) TABLET, DELAYED RELEASE [DUCHESNAY USA, INC.]",
"spl_version": "15",
"published_date": "2025-12-04"
}
},
"productid": "55494-100_19a108be-4aba-4906-8a5d-35f5b263b1c2",
"productndc": "55494-100",
"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": "DICLEGIS",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "NDA021876",
"marketing_category": "NDA",
"nonproprietary_name": "doxylamine succinate and pyridoxine hydrochloride",
"start_marketing_date": "20130515",
"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)
- 🇺🇸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
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