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United States · US · US:41167-0608_d16a629c-c038-4ab2-a330-9df512db0288
Unisom SleepTabs
In shortageOrange BookUNIISPLATC R06AA59
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerChattem, Inc.
CountryUS (United States)
ATC codeR06AA59
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc1141167060801 BLISTER PACK in 1 CARTON (41167-0608-0) / 16 TABLET in 1 BLISTER PACK
- ndc1141167060811 BOTTLE in 1 CARTON (41167-0608-1) / 32 TABLET in 1 BOTTLE
- ndc1141167060821 BOTTLE in 1 CARTON (41167-0608-2) / 48 TABLET in 1 BOTTLE
- ndc1141167060831 BOTTLE in 1 CARTON (41167-0608-3) / 80 TABLET in 1 BOTTLE
- ndc1141167060841 BLISTER PACK in 1 CARTON (41167-0608-4) / 4 TABLET in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
V9BI9B5YI2
DOXYLAMINE SUCCINATE
RxCUI 23665
Orange Book
A040564
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": {
"7ae32d74-76a0-47e2-9e5c-812426413c4e": {
"match": "brand_token",
"title": "UNISOM SLEEPTABS (DOXYLAMINE SUCCINATE) TABLET [CHATTEM, INC.]",
"spl_version": "1",
"published_date": "2026-03-25"
}
},
"productid": "41167-0608_d16a629c-c038-4ab2-a330-9df512db0288",
"productndc": "41167-0608",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "040564",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "25MG",
"product_no": "001",
"approval_date": "Aug 27, 2004"
}
],
"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": "Unisom SleepTabs",
"active_ingred_unit": "mg/1",
"application_number": "ANDA040564",
"marketing_category": "ANDA",
"nonproprietary_name": "Doxylamine Succinate",
"start_marketing_date": "20260316",
"active_numerator_strength": "25"
}Related drugs
Other records sharing ATC code R06AA59.
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