Back to search
🇺🇸

United States · US · US:68071-4533_2d53b71b-7709-e12d-e063-6294a90a5478

ACETAMINOPHEN AND CODEINE PHOSPHATE

In shortageOrange BookUNIISPLATC N02BE

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

Identification

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

Packs · 6

  • ndc11
    6807145332
    20 TABLET in 1 BOTTLE (68071-4533-2)
  • ndc11
    6807145333
    30 TABLET in 1 BOTTLE (68071-4533-3)
  • ndc11
    6807145334
    24 TABLET in 1 BOTTLE (68071-4533-4)
  • ndc11
    6807145335
    15 TABLET in 1 BOTTLE (68071-4533-5)
  • ndc11
    6807145336
    60 TABLET in 1 BOTTLE (68071-4533-6)
  • ndc11
    6807145338
    84 TABLET in 1 BOTTLE (68071-4533-8)

Annotations

UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A040419
AAAAAA
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": "68071-4533_2d53b71b-7709-e12d-e063-6294a90a5478",
  "productndc": "68071-4533",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "040419",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AA",
        "strength": "300MG;15MG",
        "product_no": "001",
        "approval_date": "May 31, 2001"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AA",
        "strength": "300MG;30MG",
        "product_no": "002",
        "approval_date": "May 31, 2001"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AA",
        "strength": "300MG;60MG",
        "product_no": "003",
        "approval_date": "May 31, 2001"
      }
    ],
    "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 PHOSPHATE",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA040419",
  "marketing_category": "ANDA",
  "nonproprietary_name": "acetaminophen and codeine phosphate",
  "start_marketing_date": "20110706",
  "active_numerator_strength": "300; 30"
}

Related drugs

Other records sharing ATC code N02BE.

Access this data programmatically

Query ACETAMINOPHEN AND CODEINE PHOSPHATE and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.