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United States · US · US:72189-399_2c4ce870-c59f-df00-e063-6394a90a9011

Norco

In shortageOrange BookUNIISPLATC N02BE

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

Identification

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

Packs · 4

  • ndc11
    7218939930
    30 TABLET in 1 BOTTLE (72189-399-30)
  • ndc11
    7218939960
    60 TABLET in 1 BOTTLE (72189-399-60)
  • ndc11
    7218939972
    120 TABLET in 1 BOTTLE (72189-399-72)
  • ndc11
    7218939990
    90 TABLET in 1 BOTTLE (72189-399-90)

Annotations

UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A040400
AA
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": {
    "ee248dfd-7aa7-7dcc-e053-2995a90af19f": {
      "match": "brand_token",
      "title": "NORCO (HYDROCODONE/APAP) TABLET [DIRECT_RX]",
      "spl_version": "3",
      "published_date": "2025-01-23"
    }
  },
  "productid": "72189-399_2c4ce870-c59f-df00-e063-6394a90a9011",
  "productndc": "72189-399",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "040400",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AA",
        "strength": "325MG;10MG",
        "product_no": "001",
        "approval_date": "Jul 26, 2000"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ACETAMINOPHEN; HYDROCODONE BITARTRATE",
  "shortage_reason": "Acetaminophen; Oxycodone Hydrochloride Tablet",
  "shortage_status": "current",
  "proprietary_name": "Norco",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA040400",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Hydrocodone/APAP",
  "start_marketing_date": "20221123",
  "active_numerator_strength": "325; 10"
}

Related drugs

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