🇺🇸
United States · US · US:68391-441_6aed4ba1-211a-4e76-bc4c-0ca3a57fb66a
berkley and jensen sleep aid
In shortageOrange BookUNIISPLATC R06AA59
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBJWC
CountryUS (United States)
ATC codeR06AA59
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1168391441022 BOTTLE in 1 CARTON (68391-441-02) / 96 TABLET in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
V9BI9B5YI2
DOXYLAMINE SUCCINATE
RxCUI 23665
Orange Book
A040167
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": {
"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": "68391-441_6aed4ba1-211a-4e76-bc4c-0ca3a57fb66a",
"productndc": "68391-441",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "040167",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "25MG",
"product_no": "001",
"approval_date": "Sep 18, 1996"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "DOXYLAMINE SUCCINATE",
"shortage_reason": "Doxylamine Succinate and Pyridoxine Hydrochloride Tablet, Delayed Release",
"shortage_status": "current",
"proprietary_name": "berkley and jensen sleep aid",
"active_ingred_unit": "mg/1",
"application_number": "ANDA040167",
"marketing_category": "ANDA",
"nonproprietary_name": "Doxylamine succinate",
"start_marketing_date": "20180806",
"active_numerator_strength": "25"
}Related drugs
Other records sharing ATC code R06AA59.
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