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United States · US · US:76281-502_46e2d507-7545-48c8-e063-6294a90a6c67

Nite-Time

In shortageUNIISPLATC N02BE

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerAptaPharma Inc.
CountryUS (United States)
ATC codeN02BE
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    7628150224
    118 mL in 1 BOTTLE (76281-502-24)
  • ndc11
    7628150225
    177 mL in 1 BOTTLE (76281-502-25)
  • ndc11
    7628150228
    354 mL in 1 BOTTLE (76281-502-28)

Annotations

UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Acetaminophen; Oxycodone Hydrochloride Tablet
Raw payload (JSON)
{
  "unii": {
    "unii": "362O9ITL9D",
    "rxcui": "161",
    "inchikey": "RZVAJINKPMORJF-UHFFFAOYSA-N",
    "display_name": "ACETAMINOPHEN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "87c2b823-ed88-44f3-8f6a-df30430b40f3": {
      "match": "brand_token",
      "title": "NITE-TIME COLD/FLU MEDICINE CHERRY (ACETAMINOPHEN) LIQUID [APTAPHARMA INC.]",
      "spl_version": "11",
      "published_date": "2025-12-29"
    }
  },
  "productid": "76281-502_46e2d507-7545-48c8-e063-6294a90a6c67",
  "productndc": "76281-502",
  "dosage_form": "LIQUID",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE",
  "shortage_reason": "Acetaminophen; Oxycodone Hydrochloride Tablet",
  "shortage_status": "current",
  "proprietary_name": "Nite-Time",
  "active_ingred_unit": "mg/30mL; mg/30mL; mg/30mL",
  "application_number": "M012",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "ACETAMINOPHEN",
  "start_marketing_date": "20180101",
  "active_numerator_strength": "650; 30; 12.5"
}

Related drugs

Other records sharing ATC code N02BE.

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