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United States · US · US:76420-103_b2dde53b-af58-ce44-e053-2a95a90a8fe0

Acetaminophen and Codeine

In shortageOrange BookUNIISPLATC N02BE

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

Identification

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

Packs · 4

  • ndc11
    7642010303
    3 TABLET in 1 BOTTLE (76420-103-03)
  • ndc11
    7642010310
    10 TABLET in 1 BOTTLE (76420-103-10)
  • ndc11
    7642010320
    20 TABLET in 1 BOTTLE (76420-103-20)
  • ndc11
    7642010330
    30 TABLET in 1 BOTTLE (76420-103-30)

Annotations

UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A040779
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": {
    "44520aa1-b63f-4239-e063-6394a90a5e14": {
      "match": "brand_token",
      "title": "ACETAMINOPHEN LIQUID / ACETAMINOPHEN DIPHENHYDRAMINE HCL LIQUID (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) KIT [KROGER]",
      "spl_version": "2",
      "published_date": "2026-06-02"
    }
  },
  "productid": "76420-103_b2dde53b-af58-ce44-e053-2a95a90a8fe0",
  "productndc": "76420-103",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "040779",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "300MG;30MG",
        "product_no": "001",
        "approval_date": "May 29, 2008"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CIII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ACETAMINOPHEN; CODEINE PHOSPHATE",
  "shortage_reason": "Acetaminophen; Oxycodone Hydrochloride Tablet",
  "shortage_status": "current",
  "proprietary_name": "Acetaminophen and Codeine",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA040779",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Acetaminophen and Codeine",
  "start_marketing_date": "20080529",
  "active_numerator_strength": "300; 30"
}

Related drugs

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