Unisom SleepTabs

In shortageOrange BookUNIISPLATC R06AA59

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerChattem, Inc.

CountryUS (United States)

ATC codeR06AA59

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
4116700635
1 BLISTER PACK in 1 CARTON (41167-0063-5) / 16 TABLET in 1 BLISTER PACK
ndc11
4116700636
1 BOTTLE, PLASTIC in 1 CARTON (41167-0063-6) / 32 TABLET in 1 BOTTLE, PLASTIC
ndc11
4116700637
1 BOTTLE, PLASTIC in 1 CARTON (41167-0063-7) / 48 TABLET in 1 BOTTLE, PLASTIC
ndc11
4116700638
1 BOTTLE, PLASTIC in 1 CARTON (41167-0063-8) / 80 TABLET in 1 BOTTLE, PLASTIC

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": {
    "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": "41167-0063_32b4f344-3f75-4804-b8cb-800fe2b508c0",
  "productndc": "41167-0063",
  "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": "Unisom SleepTabs",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA040167",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Doxylamine Succinate",
  "start_marketing_date": "20160115",
  "active_numerator_strength": "25"
}

Related drugs

Other records sharing ATC code R06AA59.

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